Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Drugs such as, flutamide or bicalutamide may stop the adrenal glands from producing androgens. Giving radiation therapy with hormone therapy after surgery to remove the tumor may kill any tumor cells remaining after surgery and be an effective treatment for stage II or stage III prostate cancer. It is not yet known if radiation therapy combined with hormone therapy is more effective than either radiation therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer. (Hormone therapy alone group closed as of 12/9/2002.)
PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant radiation therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in treating patients who have stage II or stage III prostate cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Compare the overall survival, disease-free survival, freedom from distant metastases, and freedom from PSA failure in patients with high-risk stage II or III prostate cancer treated in the adjuvant setting with radiotherapy and hormonal therapy vs radiotherapy alone.
- Compare the qualitative and quantitative toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to seminal vesicle invasion (yes vs no), preoperative PSA (10 ng/mL or less vs greater than 10 ng/mL), Gleason score (2-6 vs 7 vs 8-10), positive surgical margins (yes vs no), and neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm III closed to accrual as of 12/9/2002.)
- Arm I: Patients undergo radiotherapy once daily 5 days a week for 7 weeks. Beginning the first day of radiotherapy, patients also receive hormonal therapy comprising a luteinizing-hormone-releasing hormone agonist once every 1-4 months for 2 years AND oral flutamide 3 times daily OR oral bicalutamide once daily for 1 month.
- Arm II: Patients undergo radiotherapy as in arm I.
- Arm III (Closed to accrual as of 12/9/2002):Patients receive hormonal therapy 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 1,398 patients (699 per treatment arm) will be accrued for this study within 5 years. (Arm III closed to accrual as of 12/9/2002.)
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
- T2-3, N0, M0
- No metastatic disease
High-risk for PSA relapse as defined by Gleason score 7 or higher and ≥ 1 of the following OR Gleason score < 7 and ≥ 2 of the following:
- Preoperative PSA > 10 ng/mL
- Positive surgical margins
- Seminal vesicle invasion
- Preoperative PSA ≤ 40.0 ng/mL
- Postoperative PSA ≤ 0.2 ng/mL
Negative lymph node status by lymph node sampling or dissection
- If lymph node status is unknown, must have < 5% risk of involvement by Roach formula
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 130,000/mm^3
- Hemoglobin ≥ 11.4 g/dL
Hepatic:
- ALT ≤ 3 times normal
Renal:
- Creatinine ≤ 2.5 mg/dL
Other:
- No other prior or concurrent invasive malignancy within the past 5 years except superficial nonmelanoma skin cancer
- No other major medical or psychiatric illness that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 5 years since prior chemotherapy
Endocrine therapy:
- At least 60 days since prior finasteride
- At least 90 days since prior testosterone
- Prior pharmacologic androgen ablation for prostate cancer allowed if initiated within the past 10 months (must switch to study ablation therapy OR discontinue therapy if randomized to receive radiotherapy only)
Radiotherapy:
- No prior radiotherapy to the pelvis
- No concurrent intensity-modulated radiotherapy
Surgery:
- No prior orchiectomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LH-RH agonist plus radiation therapy
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy
|
|
|
Active Comparator: Radiation therapy alone
Radiation therapy alone to 63.0 - 66.6 Gy
|
|
|
Active Comparator: LH-RH agonist alone
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: From the date of randomization to the date of death due to any cause
|
From the date of randomization to the date of death due to any cause
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Disease-Free Survival
Time Frame: From the date of randomization to the date of first documented local progression or distant failure
|
From the date of randomization to the date of first documented local progression or distant failure
|
|
Distant Failure
Time Frame: From the date of randomization to the date of frist documented metastatic disease
|
From the date of randomization to the date of frist documented metastatic disease
|
|
Biochemical Failure (detectable PSA)
Time Frame: From the date of randomization to the date of developing a PSA of 0.5 ng/ml or greater over the entry PSA
|
From the date of randomization to the date of developing a PSA of 0.5 ng/ml or greater over the entry PSA
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Richard K. Valicenti, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
- Study Chair: Richard Choo, MD, Toronto Sunnybrook Regional Cancer Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Androgen Antagonists
- Hormones
- Bicalutamide
- Flutamide
Other Study ID Numbers
- RTOG-P-0011
- CDR0000068868
- CAN-NCIC-PR9
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