Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments bicalutamide, flutamide, releasing hormone agonist therapy, neoadjuvant therapy, radiation therapy
Phase phase 3
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date February 2000
End date May 2018
Trial size 1579 participants
Trial identifier NCT00005044, CDR0000067635, RTOG-9910

Summary

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
bicalutamide
flutamide
releasing hormone agonist therapy
neoadjuvant therapy
radiation therapy
(Experimental)
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
bicalutamide
flutamide
releasing hormone agonist therapy
neoadjuvant therapy
radiation therapy

Primary Outcomes

Measure
Disease-specific survival
time frame: From the date of randomization to the date of death due to prostate cancer or last follow-up.

Secondary Outcomes

Measure
Overall survival
time frame: From the date of randomization to the date of death or last follow-up. Analysis will occur at the time of the primary endpoint analysis.
Disease-free survival
time frame: From the date of randomization to the date of disease progression, death from any cause, or last follow-up. Analysis will occur at the time of the primary endpoint analysis.
Clinical patterns of tumor recurrence
time frame: From the date of randomization to the date of tumor recurrence or last follow-up. Analysis will occur at the time of the primary endpoint analysis.
Time to first biochemical failure
time frame: From randomization to the date of first biochemical failure, defined as a consistent and significant rise in the serum PSA level, or last follow-up. Analysis will occur at the time of the primary endpoint analysis.
Time to second biochemical failure
time frame: From randomization to the date of second biochemical failure, defined as a consistent and significant rise in the serum PSA level, or last follow-up. Analysis will occur at the time of the primary endpoint analysis.
Treatment-induced morbidity
time frame: From start of treatment to 90 days from the end of treatment.

Eligibility Criteria

Male participants from 18 years up to 120 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Intermediate risk for disease relapse as determined by any of the following combination of factors: - T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10 but no greater than 100 ng/mL - T1b-4, Gleason score 7, and PSA less than 20 ng/mL - T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL - Must have disease confirmation within 180 days of study randomization - Clinically negative lymph nodes (N0) as established by imaging or negative lymph nodes by nodal sampling or dissection - Radiologic or radioimmunoscintigraphy findings suggestive of regional nodal involvement allowed provided cytologic or histologic evaluation shows no evidence of a neoplastic process - Equivocal radiologic findings (i.e., maximum nodal size no greater than 1.5 cm) allowed - No distant metastases (M0) - Radionuclide imaging findings suggestive but not diagnostic of metastatic disease allowed provided radiologic imaging does not confirm metastatic disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0 or 1 Life expectancy: - At least 10 years Hematopoietic: - Not specified Hepatic: - ALT no greater than 2 times upper limit of normal Renal: - Not specified Other: - Fertile patients must use effective contraception - No other concurrent medical illness that would result in a life expectancy of less than 10 years - No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer - No other concurrent major medical or psychiatric illness that would preclude study treatment or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for prostate cancer Endocrine therapy: - No prior androgen-deprivation therapy except luteinizing hormone-releasing hormone (LHRH) agonist AND bicalutamide OR flutamide provided: - LHRH agonist was initiated no more than 30 days before study randomization and bicalutamide OR flutamide was initiated no more than 14 days before or after LHRH agonist administration - No concurrent finasteride for prostatic hypertrophy Radiotherapy: - No prior pelvic external beam radiotherapy - No prior radionuclide prostate brachytherapy - No concurrent intensity-modulated radiotherapy Surgery: - No prior prostatectomy - No prior prostatic cryosurgery - No prior bilateral orchiectomy Other: - No other concurrent medical research study involving prostate cancer treatment

Additional Information

Official title A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer
Description OBJECTIVES: - Compare the efficacy of moderate-duration (28 weeks) neoadjuvant total androgen suppression (TAS) and radiotherapy (RT) with short-duration (8 weeks) neoadjuvant TAS and RT, as related to disease-specific survival, in patients with intermediate-risk adenocarcinoma of the prostate. - Compare these regimens, in terms of overall survival, disease-free survival, time to local tumor progression or distant failure, time to first biochemical failure, hormone-refractory state, and treatment-induced morbidity, in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen level (no greater than 10 ng/mL vs greater than 10 but no greater than 20 ng/mL vs greater than 20 ng/mL), tumor stage (T1b-2 vs T3-4), Gleason score (2-4 vs 5-6 vs 7-10), and prior hormonal therapy (yes vs no). Patients are randomized to one of two treatment arms. - Arm I: Patients receive total androgen suppression for 8 weeks prior to the initiation of radiotherapy and throughout radiotherapy. A luteinizing hormone-releasing hormone (LHRH) agonist is administered every 1-3 months AND bicalutamide OR flutamide is given orally daily for a total duration of 16 weeks. Beginning with week 9, patients undergo radiotherapy 5 days a week for 8 weeks. - Arm II: Patients receive total androgen suppression for 28 weeks prior to the initiation of radiotherapy and throughout radiotherapy. An LHRH agonist AND bicalutamide OR flutamide are administered as in arm I for a total duration of 36 weeks. Beginning with week 29, patients undergo radiotherapy as in arm I. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,540 patients (770 per treatment arm) will be accrued for this study within 4 years.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.