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GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

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Overview Studies Clinical Trials

Terminated PHASE2, PHASE3 INTERVENTIONAL NCT01603420

External Beam Radiation With or Without Chemotherapy to Treat High Risk Prostate Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy.

Detailed Description

The recommended treatment for a high risk prostate cancer consists of a combination of radiation therapy and androgen suppression for 2-3 years. Recent studies have shown a survival advantage for chemotherapy for prostate cancer. Chemotherapy has already been successfully integrated in the treatment of other cancer types and is our belief that chemotherapy will prove to be beneficial for patients with high risk prostate cancer. However, a clinical study is necessary to compare the results good or bad of chemotherapy with radiation therapy.

Interventions

Name: Luteinizing hormone-releasing hormone (LHRH)

Type: DRUG

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

Name: Docetaxel

Type: DRUG

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

Name: Conformal Radiation Therapy (RT)

Type: OTHER

Description: 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).

Primary Outcomes

Measure: Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm

TimeFrame: 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.

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).

Measure: Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm

TimeFrame: at 5 years

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.

Measure: Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.

TimeFrame: 2 years

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).

Measure: Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.

TimeFrame: at 5 years

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.

Trial Information

NCT ID

NCT01603420

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2, PHASE3

Sponsor

Proton Collaborative Group

Last Updated

December 15, 2025

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