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External Beam Radiation With or Without Chemotherapy to Treat High Risk 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: NCT01603420
Recruitment Status : Terminated (enrollment goals not met)
First Posted : May 22, 2012
Results First Posted : August 31, 2015
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Luteinizing hormone-releasing hormone (LHRH)
Drug: Docetaxel
Other: Conformal Radiation Therapy (RT)
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Hide Arm/Group Description

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH Total
Hide Arm/Group Description

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
0
   0.0%
1
  50.0%
>=65 years
0
   0.0%
1
 100.0%
1
  50.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
53
(53 to 53)
72
(72 to 72)
62.5
(53 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
2
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
2
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
 100.0%
0
   0.0%
1
  50.0%
White
0
   0.0%
1
 100.0%
1
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm
Hide Description

Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (Prostate Specific Antigen [PSA] > = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation.

This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).

Time Frame No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.
Hide Outcome Measure Data
Hide Analysis Population Description
No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.
Arm/Group Title Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: failure events
0 0
2.Primary Outcome
Title Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm
Hide Description

This endpoint will be examined if decision is made to not move forward with phase 3 study.

This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.

Time Frame at 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.
Hide Description

Assessment will be performed using CTCAE v4 criteria.

This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).
Arm/Group Title Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: events
0 0
4.Primary Outcome
Title Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.
Hide Description

The events for FFF will be the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA > = ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage androgen deprivation.

This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.

Time Frame at 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.
Arm/Group Title Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events
Hide Description Assessment will be performed using CTCAE v 4 criteria.
Time Frame at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: incidences
0 1
6.Secondary Outcome
Title Assessment of Number of GI and GU Adverse Events
Hide Description

Descriptive measurements of frequency will be compiled.

This study was terminated prior to the time frame of 3 years being reached. Therefore, this outcome was not assessed. Data were collected on toxicities up until study closure at 22 months. However, this timepoint was not indicated as a secondary objective in the protocol. Therefore, data was not analyzed at time of study closure.

Time Frame at 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Assessment of Total Number of Local/Distant Failures
Hide Description The total number of local/distant failures will be assessed.
Time Frame at time of study closure (22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
0 0
8.Secondary Outcome
Title Assessment of Impotence by Summation of Relative Scores for Sexual Function From the EPIC Quality of Life Instrument.
Hide Description unable to assess due to lack of data
Time Frame Up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
unable to assess due to study termination
Arm/Group Title Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.
Hide Description The total number of subjects with salvage androgen deprivation use will be assessed.
Time Frame At study closure (22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
0 0
10.Secondary Outcome
Title Assessment of Total Number of Survival Events With Comparison of Group Arms
Hide Description The number of deaths in both arms will be assessed.
Time Frame at study closure (22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
0 0
11.Secondary Outcome
Title Assessment of Total Number of Biochemical Failure Events
Hide Description The number of biochemical failure events will be assessed on both arms.
Time Frame at study closure (22 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
0 0
12.Secondary Outcome
Title Assessment of Quality of Life - Summation of Relative Scores From the EPIC Instrument.
Hide Description unable to assess due to lack of data
Time Frame Up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
unable to assess due to study termination
Arm/Group Title Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone
Hide Arm/Group Description:

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Hide Arm/Group Description

Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).

LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

All-Cause Mortality
Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiation + 24mo LHRH Radiation + Chemo + 6mo LHRH
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)    
Gastrointestinal disorders     
diarrhea  0/1 (0.00%)  0 1/1 (100.00%)  1
General disorders     
fatigue  1/1 (100.00%)  1 0/1 (0.00%)  0
Psychiatric disorders     
agitation  1/1 (100.00%)  1 0/1 (0.00%)  0
Renal and urinary disorders     
urinary retention  1/1 (100.00%)  1 0/1 (0.00%)  0
urinary incontinence  1/1 (100.00%)  1 1/1 (100.00%)  1
urinary tract pain  0/1 (0.00%)  0 1/1 (100.00%)  1
hematuria  0/1 (0.00%)  0 1/1 (100.00%)  1
Skin and subcutaneous tissue disorders     
dermatitis radiation  1/1 (100.00%)  1 1/1 (100.00%)  1
Vascular disorders     
hot flashes  1/1 (100.00%)  1 0/1 (0.00%)  0
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: Corey Woods
Organization: The Proton Collaborative Group
Phone: 630-836-8668
EMail: cwoods@pcgresearch.org
Layout table for additonal information
Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT01603420     History of Changes
Other Study ID Numbers: GU004-11
First Submitted: May 18, 2012
First Posted: May 22, 2012
Results First Submitted: July 31, 2015
Results First Posted: August 31, 2015
Last Update Posted: March 14, 2016