Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Vitamins

Docetaxel

Androgens

Hormones

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

Androgen Suppression Therapy and Radiation therapy

Docetaxel plus androgen suppression therapy and radiation therapy

60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.

Total Androgen Ablation and external beam radiation therapy

Androgen Hormonal Suppression and Radiation

Total Androgen Ablation and External Beam Radiation Therapy

Androgen Suppression Therapy and Radiation Therapy

Anthony V. D'Amico, MD, PhD

This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.

Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docetaxel (Taxotere)will make this treatment more effective. Docetaxel has shown a benefit in median survival when given to men who have become resistant to hormonal therapy and in men who have metastatic prostate cancer (spread to other areas of the body).

Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial

Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up

Time to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir).

10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk.

Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model.

Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study.

Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other.

Sanofi

Dana-Farber Cancer Institute

Principal Investigator

Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.

Androgen Suppression Therapy and Radiation therapy

Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy

Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy

Arm1: Androgen Suppression Therapy + Radiation Therapy

Docetaxel plus androgen suppression therapy and radiation therapy

Docetaxel: 60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.

Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy

Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy

Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy

Androgen Suppression Therapy + Radiation therapy

Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression

Docetaxel + Androgen Suppression Therapy + Radiation Therapy

Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression

Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy

Total

Age, Continuous

Sex: Female, Male

White

Black or African American

Asian

Other

Race/Ethnicity, Customized

United States

Australia

New Zealand

Region of Enrollment

Anthony D'Amico

Androgen Suppression Therapy + Radiation Therapy

Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression

Docetaxel + Androgen Suppression Therapy + Radiation Therapy

Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles

Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles

Weeks 18-26: total androgen suppression

10-Year Restricted Mean Survival Time for Overall Survival

Androgen Suppression Therapy and Radiation Therapy

Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression

Docetaxel + Androgen Suppression Therapy and Radiation Therapy

Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles

Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles

Weeks 18-26: total androgen suppression

10-year Biochemical Recurrence (PSA Failure)

Androgen suppression Therapy + Radiation Therapy

Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression

10-year Prostate Cancer Mortality

Adverse acute events were evaluated in patients who received at least one dose of protocol treatment (174 out of 175 subjects in Arm1, 171 out of 175 subjects in Arm2).

Number of Participants With Acute Adverse Events

Adverse late event was evaluated in patients who received at least one dose of protocol treatment (174 out of 175 subjects in Arm1, 171 out of 175 subjects in Arm2).

Spots Global Cancer Trial Database for Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial