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

Alternate Title

Androgen Suppression With and Without Radiation Therapy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed Not specified NCI RTOG-9608 RTOG-96-08

Objectives

I.  Test the results of the addition of pelvic radiation therapy to total 
androgen suppression (TAS) in patients with lymph node positive adenocarcinoma 
of the prostate.

II.  Assess the differences in toxicity with the addition of pelvic radiation 
therapy to TAS.

Entry Criteria

Disease Characteristics:

Histologically confirmed localized adenocarcinoma of the prostate with 
histologically confirmed pelvic lymph node metastasis but no evidence of 
disseminated disease (T1-T4, N1-N3, M0)

Elevated prostate specific antigen (PSA) at least 4.0 ng/mL

No periaortic or common iliac lymph node involvement

No distant metastases

Not eligible for RTOG-9408, RTOG-9413 or RTOG-9601

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 No greater than 90 days since antiandrogen hormone 
 No more than 90 days since start date of replacement hormones and must not be
  different from what patient would receive after study entry (i.e., zoladex,
  lupron, and flutamide)

Radiotherapy:
 No prior radiotherapy

Surgery:
 No prior radical surgery or cryosurgery for prostate carcinoma
 No more than 90 days since orchiectomy

Patient Characteristics:

Age:
 Not specified

Performance status:
 Karnofsky 70-100%

Hematopoietic:
 Not specified 

Hepatic:
 Liver function tests (e.g., bilirubin, SGPT, SGOT) no greater than 1.2 times
  the upper limit of normal

Renal:
 Not specified

Other:
 No prior malignancy unless disease free for at least 5 years, except
  superficial basal or squamous cell skin carcinoma
 No medical or psychiatric illness that would prevent completion of study

Expected Enrollment

A total of 750 men will be accrued at rate of about 185 patients per year for 
this study.

Outline

This is a two arm, randomized study.

All patients receive total androgen suppression (TAS) either by orchiectomy 
plus flutamide three times a day orally or bicalutamide once a day orally, or 
a luteinizing hormone-releasing hormone analog such as goserelin and 
leuprolide injected monthly or every 3 months plus flutamide three times daily 
or bicalutamide daily.  Surgery must be performed no greater than 90 days 
before randomization and within 60 days after randomization.  Administration 
of goserelin, subcutaneously, or leuprolide, intramuscularly, along with 6 
capsules of flutamide or one tablet of bicalutamide daily continues 
indefinitely.

In Arm II, patients also receive radiation to the whole pelvis through the 
regional lymphatics followed by a boost to the prostate five days a week for 8 
weeks in addition to the TAS.

Follow-up is every 3 months for the remainder of the first year, every 4 
months for the second year, every 6 months for years 3-5, and then annually.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Colleen Lawton, MD, Protocol chair		Ph: 414-805-4472 Email: clawton@radonc.mcw.edu