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Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT00438464
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Prostate
Stage II Prostate Cancer
Interventions Drug: Finasteride
Other: Placebo
Procedure: Prostatectomy
Other: Laboratory biomarker analysis
Enrollment 204
Recruitment Details Recruitment period: From 2007 to 2012 recruitment was done at various medical clinic locations.
Pre-assignment Details Of the 210 participants recruited, 204 were randomized to the study.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Period Title: Overall Study
Started 103 101
Received Assigned Intervention 89 94
Completed 89 94
Not Completed 14 7
Reason Not Completed
Terminated Early             14             5
Incomplete data submission             0             2
Arm/Group Title Arm I (Finasteride) Arm II (Placebo) Total
Hide Arm/Group Description Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. Placebo once daily for 4-6 weeks, then undergo prostatectomy. Total of all reporting groups
Overall Number of Baseline Participants 89 94 183
Hide Baseline Analysis Population Description
Baseline includes participants who were randomized to arms and received assigned treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 89 participants 94 participants 183 participants
59
(45 to 73)
62
(48 to 73)
60
(45 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 94 participants 183 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
89
 100.0%
94
 100.0%
183
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants 94 participants 183 participants
Asian 1 0 1
Black 5 7 12
Hispanic 5 2 7
White 78 85 163
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 89 participants 94 participants 183 participants
89 94 183
1.Primary Outcome
Title Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Hide Description Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.
Time Frame At prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Arm/Group Title Finasteride Arm Within GG3 Placebo Arm Within GG3
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 62 68
Median (Full Range)
Unit of Measure: Percentage tumor cell involvement
VEGF (N=37,55)
80
(5 to 100)
90
(0 to 100)
ERβ (N=35, 55)
15.0
(0.03 to 59.0)
6.6
(0 to 56.3)
AR (N=35, 54)
75.2
(21.5 to 92.1)
78.3
(33.8 to 97.6)
Ki-67 (N=37,54)
1.1
(0.05 to 5.4)
1.3
(0.03 to 4.5)
SRD5A2 (N=45,47)
100
(0 to 100)
90
(0 to 100)
UBE2C (N=34,55)
0.4
(0 to 1.5)
0.3
(0 to 2.4)
Caspase (N=38,55)
0.2
(0.01 to 4.1)
0.08
(0 to 0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG3, Placebo Arm Within GG3
Comments VEGF3, Within GG3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG3, Placebo Arm Within GG3
Comments Estrogen receptor beta (ERβ), Within GG3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG3, Placebo Arm Within GG3
Comments Androgen receptor (AR), Within GG3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG3, Placebo Arm Within GG3
Comments Ki-67 protein, Within GG3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG3, Placebo Arm Within GG3
Comments 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG3, Placebo Arm Within GG3
Comments Ubiquitin-conjugating enzyme E2C (UBE2C), Within GG3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG3, Placebo Arm Within GG3
Comments Cleaved Caspase 3 (Caspase), Within GG3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Hide Description Biomarkers using pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.
Time Frame At prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Arm/Group Title Finasteride Arm Within GG4 Placebo Arm Within GG4
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 62 68
Median (Full Range)
Unit of Measure: Percentage of tumor cell involvement
VEGF (N=48,61)
85
(5 to 100)
70
(0 to 100)
ERβ (N=48,62)
8.0
(0 to 49.6)
9.5
(0 to 72.8)
AR (N=48,62)
63.71
(13.5 to 92.0)
75.9
(1.4 to 96.6)
Ki-67 (N=48,62)
1.3
(0.05 to 7.2)
1.4
(0.05 to 7.3)
SRD5A2 (N=38,69)
95
(0 to 100)
90
(0 to 100)
UBE2C (N=46,62)
0.3
(0 to 1.6)
0.3
(0 to 2.3)
Caspase (N=47,61)
0.06
(0 to 0.5)
0.04
(0 to 0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG4, Placebo Arm Within GG4
Comments Vascular Epithelial Growth Factor (VEGF3), Within GG4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG4, Placebo Arm Within GG4
Comments Estrogen receptor beta (ERβ), Within GG4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG4, Placebo Arm Within GG4
Comments Androgen receptor (AR), Within GG4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG4, Placebo Arm Within GG4
Comments Ki-67 protein, Within GG4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG4, Placebo Arm Within GG4
Comments 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG4, Placebo Arm Within GG4
Comments UBE2C, Within GG4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Finasteride Arm Within GG4, Placebo Arm Within GG4
Comments Caspase, Within GG4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Hide Description Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Time Frame At prostatectomy following maximum 6 week treatment period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Arm/Group Title Finasteride Arm Within GG3 Placebo Arm Within GG3
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 62 68
Mean (Standard Deviation)
Unit of Measure: Percentage of tumor cell involvement
VEGF (N=37,55) 63.9  (36.3) 63.7  (38)
ERβ (N=35, 55) 18.1  (15.6) 14.8  (14.7)
AR (N=35, 54) 69.8  (17.3) 72.4  (16.7)
Ki-67 (N=37,54) 1.6  (1.4) 1.5  (1.0)
SRD5A2 (N=45,47) 72.9  (37.0) 64.7  (43.7)
UBE2C (N=34,55) 0.5  (0.4) 0.5  (0.5)
Caspase (N=38,55) 0.4  (0.7) 0.2  (0.2)
4.Primary Outcome
Title Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Hide Description Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Time Frame At prostatectomy following maximum 6 week treatment period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Arm/Group Title Finasteride Arm Within GG4 Placebo Arm Within GG4
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 62 68
Mean (Standard Deviation)
Unit of Measure: Percentage of tumor cell involvement
VEGF (N=48,61) 63.6  (35.5) 59.8  (35.4)
ERβ (N=48,62) 15.0  (15.1) 16.7  (18.8)
AR (N=48,62) 64.3  (16.67) 68.6  (23.1)
Ki-67 (N=48,62) 1.8  (1.6) 1.7  (1.4)
SRD5A2 (N=38,69) 71.8  (37.6) 64.9  (40.8)
UBE2C (N=46,62) 0.5  (0.4) 0.5  (0.4)
Caspase (N=47,61) 0.1  (0.1) 0.06  (0.08)
5.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score
Hide Description Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of prostate, clinical stage T1c or T2, with Gleason score of 6 or 7 and PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy. 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) used to grade tumors based upon its microscopic appearance: a primary grade is assigned to most common tumor pattern, and a second grade to next most common tumor pattern. Gleason score (GS) is sum of the two Gleason grades, based on scale of 2-10 with lowest numbers indicating slow-growing tumor unlikely to spread and highest numbers indicating an aggressive tumor. Gleason grade = 1-5; Gleason score = 2-10; 5 and 10 indicate worst prognosis. American Joint Committee on Cancer (AJCC) staging describes extent of disease progression utilizing TNM scoring system: Tumor size, Lymph Nodes affected, Metastases. Higher stage cancers are more advanced.
Time Frame Assessment following maximum 6 week treatment period and prostatectomy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 88 93
Measure Type: Number
Unit of Measure: participants
Gleason Score 6 12 10
Gleason Score 7 71 78
Gleason Score 8 2 1
Gleason Score 9 3 4
6.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)
Hide Description Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.
Time Frame Assessment following maximum 6 week treatment period and prostatectomy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 88 93
Measure Type: Number
Unit of Measure: participants
Grade 3 65 75
Grade 4 23 18
7.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)
Hide Description Frequency of Grade 3, Grade 4 and Grade 5 tumors in two treatment groups: Participants will consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.
Time Frame Assessment following maximum 6 week treatment period and prostatectomy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 88 93
Measure Type: Number
Unit of Measure: participants
Grade 3 31 24
Grade 4 53 64
Grade 5 4 5
8.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage
Hide Description American Joint Committee on Cancer (AJCC) system 6th edition (2002) describing amount and spread of cancer body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Numbers after the T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues where T3a reflects tumor has spread through the capsule on one or both sides; and T3b reflects tumor has invaded one or both seminal vesicles.
Time Frame Assessment following maximum 6 week treatment period and prostatectomy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 89 94
Measure Type: Number
Unit of Measure: participants
pT2 73 74
pT3a 11 15
pT3b 5 5
9.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)
Hide Description Edge or border of tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.
Time Frame Assessment following maximum 6 week treatment period and prostatectomy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 89 94
Measure Type: Number
Unit of Measure: participants
Positive 17 16
Negative 67 76
Equivocal 5 2
10.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status
Hide Description Status of cancer spread to lymph nodes; PN0 Cancer that has not spread to the lymph nodes. Cancer that has not spread to the lymph nodes. The N category describes whether the cancer has spread into nearby lymph nodes. NX means the nearby lymph nodes cannot be evaluated. N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.
Time Frame Assessment following maximum 6 week treatment period and prostatectomy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 89 94
Measure Type: Number
Unit of Measure: participants
PN0 46 43
PN1 2 2
pNX 41 49
11.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci
Hide Description Diagnosis of a small focus of prostatic adenocarcinoma on a prostate needle biopsy from pathologist's identification of an architecturally abnormal focus of epithelial structures at rather low magnification.
Time Frame Assessment following maximum 6 week treatment period and prostatectomy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 89 94
Measure Type: Number
Unit of Measure: participants
1 Focus 15 11
2 Foci 18 20
3 Foci 28 28
4 Foci 13 20
>/= 5 Foci 15 15
12.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)
Hide Description Tumor distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.
Time Frame Assessment following maximum 6 week treatment period and prostatectomy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 89 94
Measure Type: Number
Unit of Measure: participants
PZ 35 38
PZ + TZ 49 50
PZ + TZ + CZ 2 2
PZ + CZ 0 1
TZ 3 3
13.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus
Hide Description Dominant tumor focus, distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. Dominant tumor focus is the largest, index lesion, single high risk focus of the prostate cancer.
Time Frame Assessment following maximum 6 week treatment period and prostatectomy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 89 94
Measure Type: Number
Unit of Measure: participants
PZ 67 73
TZ 22 21
14.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy
Hide Description Change in Gleason Score from biopsy to prostatectomy where an upgrade refers to a higher Gleason Score signifying worsening of tumor. Gleason scoring (GS) to based on microscopic appearance using 2005 International Society of Urological Pathologists recommendation.
Time Frame Baseline biopsy to prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 89 94
Measure Type: Number
Unit of Measure: participants
No 63 70
Yes 26 24
15.Secondary Outcome
Title Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)
Hide Description Characteristics of tumor considering total zone cancer volume, and cancer volume using zonal foci categorized as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.
Time Frame Baseline biopsy to prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 89 94
Median (Full Range)
Unit of Measure: cubic centimeter
Total
1.0
(0.0 to 9.3)
0.8
(0.0 to 10.4)
PZ Cancer focus/foci
0.6
(0.0 to 9.3)
0.5
(0.0 to 9.0)
TZ cancer focus/foci
0.0
(0.0 to 6.0)
0.0
(0.0 to 10.4)
16.Secondary Outcome
Title Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)
Hide Description Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells.
Time Frame Baseline biopsy to prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 75 80
Median (Full Range)
Unit of Measure: percentage of change
-39.4
(-96.6 to 155.2)
-4.6
(-61.2 to 200.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Finasteride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Secondary Outcome
Title Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change
Hide Description Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood.
Time Frame Baseline biopsy to prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 76 80
Median (Full Range)
Unit of Measure: percentage of change
13
(-53 to 158)
-4.6
(-80.7 to 76.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Finasteride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
18.Secondary Outcome
Title Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change
Hide Description Characteristics of blood biomarkers using pretreatment and posttreatment values. Dihydrotestosterone (DHT) blood test measures serum concentrations of dihydrotestosterone and is closely related to those of testosterone.
Time Frame Baseline biopsy to prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 74 79
Median (Full Range)
Unit of Measure: percentage of change
-64.8
(-90 to 120)
-3.6
(-64.7 to 615.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Finasteride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
19.Secondary Outcome
Title Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change
Hide Description Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estrone (E1), one of the three estrogens, which also includes estriol and estradiol.
Time Frame Baseline biopsy to prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 75 79
Median (Full Range)
Unit of Measure: percentage of change
-8.9
(-93.2 to 870)
0
(-81.8 to 760)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Finasteride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Secondary Outcome
Title Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change
Hide Description Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.
Time Frame Baseline biopsy to prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all evaluable participants.
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description:
Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Overall Number of Participants Analyzed 76 79
Median (Full Range)
Unit of Measure: percentage of change
7.2
(-80.0 to 700)
0
(-86.8 to 161.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Finasteride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.254
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
21.Secondary Outcome
Title Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
Hide Description Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Time Frame At prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Arm/Group Title GG3, Within Finasteride Arm GG4, Within Finasteride Arm
Hide Arm/Group Description:
Participants with GG3 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
Participants with GG4 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
Overall Number of Participants Analyzed 62 62
Mean (Standard Deviation)
Unit of Measure: Percentage of tumor cell involvement
VEGF (N=37,48) 63.9  (36.3) 63.7  (35.5)
ERβ (N=35,48) 18.1  (15.6) 15.0  (15.1)
AR (N=35,48) 69.8  (17.3) 64.3  (16.7)
Ki-67 (N=37,48) 1.6  (1.4) 1.8  (1.6)
SRD5A2 (N=45,38) 72.9  (37.0) 71.8  (37.6)
UBE2C (N=34,46) 0.5  (0.4) 0.5  (0.4)
Caspase (N=38,47) 0.4  (0.7) 0.1  (0.1)
22.Secondary Outcome
Title Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
Hide Description Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Time Frame At prostatectomy following maximum 6 week treatment period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Arm/Group Title GG3, Within Placebo Arm GG4, Within Placebo Arm
Hide Arm/Group Description:
Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: Percentage of tumor cell involvement
VEGF (N=55,61) 63.7  (38) 59.7  (35.4)
ERβ (N=55,62) 14.8  (14.7) 16.7  (18.8)
AR (N=54,62) 72.4  (16.7) 68.6  (23.1)
Ki-67 (N=54,62) 1.5  (1.0) 1.7  (1.4)
SRD5A2 (N=47,69) 64.7  (43.7) 64.9  (40.8)
UBE2C (N=55,62) 0.5  (0.5) 0.5  (0.4)
Caspase (N=55,61) 0.2  (0.2) 0.06  (0.08)
23.Secondary Outcome
Title Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
Hide Description Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.
Time Frame At prostatectomy following maximum 6 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Arm/Group Title Within GG3, Finasteride Arm Within GG4, Finasteride Arm
Hide Arm/Group Description:
Participants with GG3 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
Participants with GG4 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
Overall Number of Participants Analyzed 62 62
Median (Full Range)
Unit of Measure: Percentage of tumor cell involvement
VEGF (N=37,48)
80
(5 to 100)
85
(5 to 100)
ERβ (N=35,48)
15.0
(0.03 to 58.9)
8.0
(0 to 49.56)
AR (N=35,48)
75.2
(21.5 to 92.1)
63.7
(13.5 to 92.0)
Ki-67 (N=37,48)
1.1
(0.05 to 5.4)
1.3
(0.05 to 7.2)
SRD5A2 (N=45,38)
100
(0 to 100)
95
(0 to 100)
UBE2C (N=34,46)
0.4
(0 to 1.5)
0.3
(0 to 1.6)
Caspase (N=38,47)
0.2
(0.01 to 4.1)
0.06
(0 to 0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Within GG3, Finasteride Arm, Within GG4, Finasteride Arm
Comments VEGF3, Within Finasteride Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Within GG3, Finasteride Arm, Within GG4, Finasteride Arm
Comments ERβ, Within Finasteride Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Within GG3, Finasteride Arm, Within GG4, Finasteride Arm
Comments AR, Within Finasteride
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Within GG3, Finasteride Arm, Within GG4, Finasteride Arm
Comments Ki-67 protein, Within Finasteride Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Within GG3, Finasteride Arm, Within GG4, Finasteride Arm
Comments SRD5A2, Within Finasteride Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Within GG3, Finasteride Arm, Within GG4, Finasteride Arm
Comments UBE2C, Within Finasteride Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Within GG3, Finasteride Arm, Within GG4, Finasteride Arm
Comments Caspase, Within Finasteride Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
24.Secondary Outcome
Title Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
Hide Description Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.
Time Frame At prostatectomy following maximum 6 week treatment period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
Arm/Group Title Within GG3, Placebo Arm Within GG4, Placebo Arm
Hide Arm/Group Description:
Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
Overall Number of Participants Analyzed 68 68
Median (Full Range)
Unit of Measure: Percentage of tumor cell involvement
VEGF (N=55,61)
90
(0 to 100)
70
(0 to 100)
ERβ (N=55,62)
6.6
(0 to 56.3)
9.5
(0 to 72.8)
AR (N=54,62)
78.3
(33.77 to 97.6)
75.9
(1.39 to 96.6)
Ki-67 (N=54,62)
1.3
(0.03 to 4.5)
1.4
(0.05 to 7.3)
SRD5A2 (N=47,69)
90
(0 to 100)
90
(0 to 100)
UBE2C (N=55,62)
0.3
(0 to 2.4)
0.3
(0 to 2.3)
Caspase (N=55,61)
0.08
(0 to 0.8)
0.04
(0 to 0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Within GG3, Placebo Arm, Within GG4, Placebo Arm
Comments VEGF3, Within Placebo Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Within GG3, Placebo Arm, Within GG4, Placebo Arm
Comments ERβ, Within Placebo Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Within GG3, Placebo Arm, Within GG4, Placebo Arm
Comments AR, Within Placebo Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Within GG3, Placebo Arm, Within GG4, Placebo Arm
Comments Ki-67 protein, Within Placebo Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Within GG3, Placebo Arm, Within GG4, Placebo Arm
Comments SRD5A2, Within Placebo Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Within GG3, Placebo Arm, Within GG4, Placebo Arm
Comments UBE2C, Within Placebo Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Within GG3, Placebo Arm, Within GG4, Placebo Arm
Comments Caspase, Within Placebo Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame The final collection of adverse events obtained at the completion of the 4-6 week course of study medication/placebo, before prostatectomy. Overall study period: March 2007 to April 2012.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Finasteride) Arm II (Placebo)
Hide Arm/Group Description Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. Placebo once daily for 4-6 weeks, then undergo prostatectomy.
All-Cause Mortality
Arm I (Finasteride) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Finasteride) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/94 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Finasteride) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/94 (0.00%) 
Predefined molecular signature could not easily distinguish GG 4 from GG 3 tumor areas in the placebo arm.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jeri Kim, MD / Associate Professor, Genitourinary Medical Oncology
Organization: University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2830
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00438464     History of Changes
Other Study ID Numbers: NCI-2009-00856
NCI-2009-00856 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000653463
2006-0614 ( Other Identifier: M D Anderson Cancer Center )
MDA03-1-03 ( Other Identifier: DCP )
N01CN35159 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: February 20, 2007
First Posted: February 22, 2007
Results First Submitted: October 20, 2015
Results First Posted: March 9, 2016
Last Update Posted: March 9, 2016