Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	Not specified	NCI	RTOG-P-0011 RTOG-DEV-1037, CAN-NCIC-PR9, NCT00023829, PR9

Special Category: CTSU trial

Objectives

1. 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.
2. Compare the qualitative and quantitative toxic effects of these regimens in these patients.

Entry Criteria

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

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

Patient Characteristics:

Age:

• Not specified

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC ≥ 3,000/mm³
• Platelet count ≥ 130,000/mm³
• 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

Expected Enrollment

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.)

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.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Richard Valicenti, MD, Protocol chair		Ph: 215-955-5936; 800-533-3669 Email: richard.valicent@mail.tju.edu

NCIC-Clinical Trials Group

Richard Choo, MD, Protocol chair		Ph: 416-480-6165 Email: richard.choo@tsrcc.on.ca

Registry Information
Official Title		Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer
Trial Start Date		2001-08-24
Registered in ClinicalTrials.gov		NCT00023829
Date Submitted to PDQ		2001-07-09
Information Last Verified		2005-01-10
NCI Grant/Contract Number		CA21661

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