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

Alternate Title

Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	RTOG-9910 NCT00005044, RTOG-99-10

Special Category: CTSU trial

Objectives

1. 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.
2. 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.

Entry Criteria

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

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

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

Expected Enrollment

A total of 1,540 patients (770 per treatment arm) will be accrued for this study within 4 years.

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.

Paner GP, Bae K, Grignon DJ, et al.: Trends in Gleason grading of prostate cancer (PCa): analysis of reporting by institutional and central review pathologists in four Radiation Therapy Oncology Group (RTOG) protocols spanning 17 years and 2094 needle biopsies (bxs). [Abstract] United States and Canadian Academy of Pathology 96th Annual Meeting, March 24-30, 2007, San Diego, CA. A-766, 2007.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Michael Haddock, MD, Protocol chair		Ph: 507-284-2511

Registry 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
Trial Start Date		2000-02-14
Registered in ClinicalTrials.gov		NCT00005044
Date Submitted to PDQ		2000-02-08
Information Last Verified		2003-09-30
NCI Grant/Contract Number		CA21661

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