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

Alternate Title

Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Over 18	NCI	RTOG-9902 RTOG-DEV-1020, RTOG-99-02, NCT00004054

Special Category: CTSU trial

Objectives

1. Compare the efficacy of androgen suppression and radiotherapy with or without subsequent paclitaxel, estramustine, and etoposide, in terms of overall and disease-free survival, biochemical and local control, and freedom from distant metastasis, in patients with localized high-risk prostate cancer.
2. Compare the toxic effects of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven prostate cancer at high risk for relapse as determined by either of the following:
  • Prostate-specific antigen (PSA) 20-100 ng/mL and Gleason score at least 7 (any T stage)
  • Clinical stage at least T2, Gleason score at least 8, and PSA no greater than 100 ng/mL



• Negative lymph nodes



• No metastatic disease

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 5 years since prior chemotherapy

Endocrine therapy:

• At least 60 days since prior finasteride for prostatic hypertrophy
• At least 90 days since prior testosterone
• No more than 30 days since initiation of prior pharmacologic androgen ablation for prostate cancer

Radiotherapy:

• No prior pelvic radiotherapy
• No concurrent intensity-modulated radiotherapy

Surgery:

• No prior radical prostatectomy
• No prior cryosurgery for prostate cancer
• No prior orchiectomy

Patient Characteristics:

Age:

• Over 18

Performance status:

• Zubrod 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 130,000/mm³
• Hemoglobin at least 11.4 g/dL

Hepatic:

• AST no greater than 2 times upper limit of normal

Renal:

• Creatinine no greater than 2.5 mg/dL

Other:

• No other invasive cancer within the past 5 years except superficial nonmelanomatous skin cancer
• No major medical or psychiatric illness that would preclude study participation
• Fertile patients must use effective contraception

Expected Enrollment

A total of 1,440 patients will be accrued for this study within 6 years.

Outline

This is a randomized study. Patients are stratified according to prostate-specific antigen level (≤ 10 ng/mL vs 11-100 ng/mL), tumor stage (T1-2 vs T3-4), Gleason score (7 vs 8-10), and prior hormone use (yes vs no). Patients are randomized to one of two treatment arms.

All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone (LHRH) agonist AND bicalutamide OR flutamide for 4 months. Beginning 8 weeks after the initiation of androgen suppression, all patients undergo radiotherapy once daily, 5 days a week, for 7-8 weeks. Patients who received prior androgen suppression therapy count time to radiotherapy from start date of prior hormonal therapy.

• Arm I: Patients continue androgen suppression therapy (LHRH agonist only) for approximately 20 more months after radiotherapy is completed.



• Arm II: Patients continue therapy as in arm I and receive chemotherapy beginning 28 days after completing radiotherapy. Chemotherapy comprises oral estramustine 3 times daily and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Chemotherapy repeats every 21 days for 4 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Rosenthal SA, Bae K, Pienta KJ, et al.: Phase III multi-institutional trial of adjuvant chemotherapy with paclitaxel, estramustine, and oral etoposide combined with long-term androgen suppression therapy and radiotherapy versus long-term androgen suppression plus radiotherapy alone for high-risk prostate cancer: preliminary toxicity analysis of RTOG 99-02. Int J Radiat Oncol Biol Phys 73 (3): 672-8, 2009.[PUBMED Abstract]

Sandler HM, DeSilvio M, Pienta KJ, et al.: Preliminary analysis of RTOG 9902: increased toxicity observed with the use of adjuvant chemotherapy. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-190, 2006.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Howard Sandler, MD, Protocol chair		Ph: 734-936-9338; 800-865-1125 Email: hsandler@umich.edu

Registry Information
Official Title		A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy with Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer
Trial Start Date		2000-01-11
Registered in ClinicalTrials.gov		NCT00004054
Date Submitted to PDQ		1999-08-03
Information Last Verified		2004-02-12
NCI Grant/Contract Number		CA21661

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