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Trial record 78 of 103 for:    "Kennedy disease"

Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate Cancer (TARGET)

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ClinicalTrials.gov Identifier: NCT00589472
Recruitment Status : Completed
First Posted : January 9, 2008
Results First Posted : October 6, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Adenocarcinoma
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Interventions Drug: Bicalutamide
Drug: Goserelin Acetate
Other: Laboratory Biomarker Analysis
Drug: Leuprolide Acetate
Procedure: Therapeutic Conventional Surgery
Drug: Vorinostat
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Hide Arm/Group Description

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO

Period Title: Overall Study
Started 19
Completed 18
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Hide Arm/Group Description

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  73.7%
>=65 years
5
  26.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
0
   0.0%
Male
19
 100.0%
1.Primary Outcome
Title Pathologic Complete Response at the Time of Surgery
Hide Description The primary endpoint will be pathologic complete response at the time of surgery. This represents the proportion of patients with no evidence of disease in the prostate (ie, the absence of tumor in the posttherapy pathology specimen) at the time of radical prostatectomy. Pathologic complete response at the time of surgery is the primary endpoint for this study. A Simon 2-stage optimal design that differentiates between response probabilities of 0.05 and 0.20 will be used in the analysis of the pathological complete response at 12 weeks (Type I error 10% and power 90%). A maximum of 38 pts were planned for accrual onto this study. If zero or one response was observed, then the trial was to be stopped. The design had power 0.90 for a population response proportion to 0.20 using a one-sided 0.10 size test. pT2 indicates that the cancer is confined to the prostate, while pT3 indicates that there is an extraprostatic extension of the cancer.
Time Frame At 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
pT2
10
  55.6%
pT3
8
  44.4%
Complete Response
0
   0.0%
2.Secondary Outcome
Title Gleason Score
Hide Description A Gleason score is the sum of two numbers. Pathologist determines where the cancer is most prominent and assigns the primary grade, the secondary grade is assigned based on where the cancer is next most prominent. A score from one to five is assigned for each area based on how aggressive the tumor appears. A tumor with cell that appear close to normal is assigned a low Gleason score (six or below). A tumor with cells that appear clearly different from those of a normal prostate is assigned a high Gleason score (seven or above). A system of grading prostate cancer tissue based on how it looks under a microscope. Gleason scores range from 2 to 10 and indicate how likely it is that a tumor will spread. A low Gleason score means the cancer tissue is similar to normal prostate tissue and the tumor is less likely to spread; a high Gleason score means the cancer tissue is very different from normal and the tumor is more likely to spread.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: units on a scale
8
(6 to 9)
3.Secondary Outcome
Title Levels of DHEA in Blood From Radical Prostatectomy Specimens
Hide Description [Not Specified]
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: ng/dL
256
(81 to 461)
4.Secondary Outcome
Title Levels of DHEA-S in Blood From Radical Prostatectomy Specimens
Hide Description [Not Specified]
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: mcg/dL
90
(24.9 to 221)
5.Secondary Outcome
Title Levels of DHT in Blood From Radical Prostatectomy Specimens
Hide Description [Not Specified]
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: ng/dL
24
(2 to 54)
6.Secondary Outcome
Title Levels of PSA in Blood From Radical Prostatectomy Specimens
Hide Description [Not Specified]
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: ng/mL
9.44
(1.19 to 41.3)
7.Secondary Outcome
Title Levels of Testosterone in Blood From Radical Prostatectomy Specimens
Hide Description [Not Specified]
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: ng/dL
319
(138 to 521)
8.Other Pre-specified Outcome
Title Protein Expression Analysis, Including AR Target Genes, PSA and TMPRSS2
Hide Description [Not Specified]
Time Frame Up to 1 year
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Safety and Tolerability of Androgen Depletion Therapy in Combination With Vorinostat as Assessed by Physical Examinations, Adverse Events, and Laboratory Assessments. Please See Adverse Events Section.
Hide Description Adverse events will be monitored at each scheduled visit and throughout the study. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Gene Expression Analysis, Including AR Target Genes, PSA and TMPRSS2
Hide Description Estimates and 95% confidence intervals for the proportion of patients with nondetectable levels of PSA and TMPRSS2 will be computed.
Time Frame at 12 weeks
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Gene Microarray Analysis
Hide Description [Not Specified]
Time Frame Up to 1 year
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Levels of Testosterone in Prostate Tissue
Hide Description [Not Specified]
Time Frame Up to 1 year
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Levels of DHT in Prostate Tissue
Hide Description [Not Specified]
Time Frame Up to 1 year
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Levels of Androstenediol in Prostate Tissue
Hide Description [Not Specified]
Time Frame Up to 1 year
Outcome Measure Data Not Reported
15.Other Pre-specified Outcome
Title Levels of Androstenedione in Prostate Tissue
Hide Description [Not Specified]
Time Frame Up to 1 year
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Levels of DHEA in Prostate Tissue
Hide Description [Not Specified]
Time Frame Up to 1 year
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Levels of DHEA-S in Prostate Tissue
Hide Description [Not Specified]
Time Frame Up to 1 year
Outcome Measure Data Not Reported
Time Frame Up to 30 days after treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Hide Arm/Group Description

Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Therapeutic Conventional Surgery: Undergo radical prostatectomy

Vorinostat: Given PO

All-Cause Mortality
Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Affected / at Risk (%) # Events
Total   2/19 (10.53%)    
Cardiac disorders   
Thrombosis  1  1/19 (5.26%)  1
Vascular disorders   
Hypertension  1  1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)
Affected / at Risk (%) # Events
Total   17/19 (89.47%)    
Blood and lymphatic system disorders   
Anemia  1  11/19 (57.89%)  24
Cardiac disorders   
Cardiac disorders-Other, specify  1  1/19 (5.26%)  1
General disorders   
Fatigue  1  1/19 (5.26%)  1
Pain  1  1/19 (5.26%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  1/19 (5.26%)  1
Blood bilirubin increased  1  1/19 (5.26%)  1
Creatinine increased  1  2/19 (10.53%)  3
INR increased  1  2/19 (10.53%)  3
Lymphocyte count decreased  1  4/19 (21.05%)  6
Neutrophil count decreased  1  1/19 (5.26%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  11/19 (57.89%)  28
Hypocalcemia  1  8/19 (42.11%)  20
Hypokalemia  1  1/19 (5.26%)  1
Hypophosphatemia  1  1/19 (5.26%)  2
Nervous system disorders   
Headache  1  1/19 (5.26%)  1
Psychiatric disorders   
Confusion  1  1/19 (5.26%)  1
Reproductive system and breast disorders   
Erectile dysfunction  1  1/19 (5.26%)  1
Vascular disorders   
Hypertension  1  2/19 (10.53%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Dr. Susan Slovin
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-422-4470
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00589472     History of Changes
Other Study ID Numbers: NCI-2009-00238
NCI-2009-00238 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
06-160
MSKCC IRB 06-160
MSKCC-06160
CDR0000579559
06-160 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
7864 ( Other Identifier: CTEP )
N01CM62205 ( U.S. NIH Grant/Contract )
N01CM62206 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
First Submitted: December 20, 2007
First Posted: January 9, 2008
Results First Submitted: March 24, 2017
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017