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Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00321698
Recruitment Status : Active, not recruiting
First Posted : May 4, 2006
Results First Posted : December 30, 2016
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Garzotto, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Radiation: Intensity-Modulated Radiation Therapy (IMRT)
Drug: Docetaxel+IMRT
Enrollment 25
Recruitment Details Subject accrual from Urology clinics started in April 2006; annual follow-up of 22 VA, 3 Oregon Health & Science University (OHSU) (25 total) subjects who completed ended in 2011; 10 year follow-up of these patients will be completed in 2021.
Pre-assignment Details Our 1 screen failure was excluded as a result of having a different type of cancer, other than non-melanoma skin cancer, within the past 5 years.
Arm/Group Title Phase I, Radiation Only Phase I, Dose 1 Phase I, Dose 2 Phase I, Dose 3 Phase II, MTD Dose
Hide Arm/Group Description

Group 1=radiation only;

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Group 2=IV over 30mins, 10mg/m2 weekly x 5 weeks starting on day one of radiation;

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.

Group 3=IV over 30mins, 20mg/m2 weekly x 5 weeks starting on day one of radiation;

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.

Group 4=IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation;

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.

MTD=Docetaxel IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation plus external beam radiation, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Period Title: Phase I, Rad Only & Dose 1-3
Started 3 3 3 3 0
Completed 3 3 3 3 0
Not Completed 0 0 0 0 0
Period Title: Phase II, MTD Dose
Started 0 0 0 0 13 [1]
Completed 0 0 0 0 13
Not Completed 0 0 0 0 0
[1]
+1 screen failure
Arm/Group Title Phase I, Radiation Only Phase I, Dose 1 Phase I, Dose 2 Phase I, Dose 3 Phase II, MTD Dose Total
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Drug: N/A

4 groups of men in phase I study.

Group 1=radiation only

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Drug: docetaxel

4 groups of men in phase I study.

Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Drug: docetaxel

4 groups of men in phase I study.

Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Drug: docetaxel

4 groups of men in phase I study.

Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Drug: docetaxel

Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 3 13 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 13 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  66.7%
2
  66.7%
2
  66.7%
3
 100.0%
11
  84.6%
20
  80.0%
>=65 years
1
  33.3%
1
  33.3%
1
  33.3%
0
   0.0%
2
  15.4%
5
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 3 participants 13 participants 25 participants
66.67  (8.14) 62.67  (7.64) 66.33  (4.93) 58.00  (6.56) 60.54  (4.58) 61.92  (5.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 13 participants 25 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
13
 100.0%
25
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 3 participants 3 participants 13 participants 25 participants
3 3 3 3 13 25
1.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide Description

Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel.

The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling).

MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped.

Time Frame 5 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I Dose 1-4
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4 groups of men in phase I study.

Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: mg/m^2
30
2.Primary Outcome
Title Pathologic Response Rate at the Phase II Dose
Hide Description

Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:

The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.

Time Frame 4-6 weeks after study treatment
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase II MTD Dose
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Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
Pathologic Stage pT2c 7
Pathologic Stage pT3a 3
Pathologic Stage pT3b 3
3.Secondary Outcome
Title Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA
Hide Description

All participants were combined for this assessment as pre-specified in the protocol.

The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported.

PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years

Time Frame Baseline (pre-treatment) and 1 month after surgery (post-treatment)
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Pre- and post-treatment PSA values were available in 22 of 25 patients.
Arm/Group Title All Research Participants
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This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.

Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.

Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).

Overall Number of Participants Analyzed 22
Mean (95% Confidence Interval)
Unit of Measure: percentage change
-49.1
(-60.3 to -36.7)
4.Secondary Outcome
Title Long-term Safety
Hide Description [Not Specified]
Time Frame Regular intervals (clinical contact)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Clinical Response to Treatment as Measured by Urologic Examination
Hide Description [Not Specified]
Time Frame Regular intervals (clinical contact)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins)
Hide Description

Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:

The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body.

Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For Phase I Dose 1-4, all participants were combined for this assessment as pre-specified in the protocol.
Arm/Group Title Phase I Dose 1-4 Phase II MTD Dose
Hide Arm/Group Description:

Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Overall Number of Participants Analyzed 12 13
Measure Type: Count of Participants
Unit of Measure: Participants
9
  75.0%
13
 100.0%
7.Secondary Outcome
Title Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures
Hide Description

Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score.

AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe.

EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate cancer patients. 4 subscales measuring urinary (further consisting of two sub-components, EPIC Urinary Incontinence Score and EPIC Urinary Obstructive/Irritative Score), bowel, sexual and hormonal changes. Scores for each of the subscales, as well as for each sub-component within the Urinary sub scale, are transformed linearly to a 0-100 scale with higher scores representing better QOL.

Time Frame Baseline and 12 Months Post-Prostatectomy
Hide Outcome Measure Data
Hide Analysis Population Description
Scores not available for some participants
Arm/Group Title All Research Participants
Hide Arm/Group Description:

This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.

Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.

Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).

Overall Number of Participants Analyzed 25
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
AUA Symptom Score Number Analyzed 24 participants
0.67
(-2.96 to 4.29)
EPIC Urinary Incontinence Score Number Analyzed 21 participants
-36.52
(-51.38 to -21.67)
EPIC Urinary Obstructive/Irritative Score Number Analyzed 22 participants
3.41
(-5.55 to 12.37)
EPIC Bowel Number Analyzed 25 participants
1.45
(-6.42 to 9.33)
EPIC Hormonal Number Analyzed 23 participants
0.00
(-6.42 to 6.42)
EPIC Sexual Number Analyzed 22 participants
-36.26
(-48.84 to -23.68)
8.Secondary Outcome
Title Clinical Progression-free Rate as Determined by <0.1ng PSA Results
Hide Description The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment.
Time Frame 3, 6, 9, 12 months and annually, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Research Participants
Hide Arm/Group Description:

This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.

Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.

Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62.8
(41.9 to 83.6)
Time Frame An average of 133.84 days.
Adverse Event Reporting Description

For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery.

Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.

 
Arm/Group Title Phase I, Radiation Only Phase I, Dose 1 Phase I, Dose 2 Phase I, Dose 3 Phase II, MTD Dose
Hide Arm/Group Description

Drug: N/A

4 groups of men in phase I study.

Group 1=radiation only

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Drug: docetaxel

4 groups of men in phase I study.

Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Drug: docetaxel

4 groups of men in phase I study.

Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Drug: docetaxel

4 groups of men in phase I study.

Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Drug: docetaxel

Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

All-Cause Mortality
Phase I, Radiation Only Phase I, Dose 1 Phase I, Dose 2 Phase I, Dose 3 Phase II, MTD Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I, Radiation Only Phase I, Dose 1 Phase I, Dose 2 Phase I, Dose 3 Phase II, MTD Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      8/13 (61.54%)    
Blood and lymphatic system disorders           
Lymphapenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  2 5/13 (38.46%)  5
Hemoglobin (L)  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0
Hypokalemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0
Hyponatremia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0
General disorders           
Difficulty with ADLs  1 [1]  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/13 (0.00%)  0
Metabolism and nutrition disorders           
Hyperglycemia  1  0/3 (0.00%)  0 2/3 (66.67%)  2 0/3 (0.00%)  0 1/3 (33.33%)  2 1/13 (7.69%)  1
Hypophosphatemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  4
Surgical and medical procedures           
Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Difficulty with activities of daily living (ADLs)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I, Radiation Only Phase I, Dose 1 Phase I, Dose 2 Phase I, Dose 3 Phase II, MTD Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/13 (0.00%)    
Patient accrual was not completed due to the sponsor withdrawing funding.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Dr. Mark Garzotto
Organization: Portland VAMC
Phone: 541-728-0665
EMail: garzotto@ohsu.edu
Layout table for additonal information
Responsible Party: Mark Garzotto, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00321698     History of Changes
Other Study ID Numbers: IRB00001581
IIT16179 ( Other Grant/Funding Number: Sanofi-Aventis funding number )
OHSU-1581 ( Other Identifier: OHSU IRB number )
PVAMC-11-1205/ M1675 ( Other Identifier: Portland VA IRB numbers )
OHSU-SOL-05077-L ( Other Identifier: OHSU Knight Cancer Institute number )
CDR0000467219 ( Other Identifier: NCI PDQ ID )
First Submitted: May 2, 2006
First Posted: May 4, 2006
Results First Submitted: December 30, 2014
Results First Posted: December 30, 2016
Last Update Posted: June 26, 2018