Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Micronutrients

Vitamins

Androgens

Hormones

Docetaxel

Leuprolide

Goserelin

Prolactin Release-Inhibiting Factors

Triptorelin Pamoate

Buserelin

Ascorbic Acid

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Estrogens, Conjugated (USP)

Estrogens

Tubulin Modulators

Antimitotic Agents

Hormone Antagonists

Antioxidants

Protective Agents

Trace Elements

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

Vitamin C

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

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).

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

Luteinizing hormone-releasing hormone (LHRH)

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

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 Radiation Therapy (RT)

Carlos Vargas, MD

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

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.

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

Phase 2/3 Study of Dose-escalated External Beam Radiation Therapy With or Without Chemotherapy for High Risk Adenocarcinoma of the Prostate

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).

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.

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).

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.

Assessment will be performed using CTCAE v 4 criteria.

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.

The total number of local/distant failures will be assessed.

The total number of subjects with salvage androgen deprivation use will be assessed.

The number of deaths in both arms will be assessed.

The number of biochemical failure events will be assessed on both arms.

Proton Collaborative Group

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).

Radiation + 24mo LHRH

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).

Radiation + Chemo + 6mo LHRH

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Corey Woods

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).

Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)

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).

Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone

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.

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

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

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).

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

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

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

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).

Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events

Assessment of Number of GI and GU Adverse Events

Assessment of Total Number of Local/Distant Failures

unable to assess due to study termination

Spots Global Cancer Trial Database for conformal radiation therapy (rt)