Androgen Deprivation Therapy in Treating Patients With Prostate Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens.

PURPOSE: This randomized phase III trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter MacCallum Cancer Centre, Australia
• Treatments: Androgen Antagonists; Androgens; Hormones

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Prostate-specific antigen (PSA) relapse OR incurable disease diagnosed within the past 2 months AND meets criteria for either of the following groups:

• Group 1

• In PSA relapse after definitive radical treatment (prostatectomy or radiotherapy), as evidenced by 1 the following:

• Post-prostatectomy PSA level ≥ 0.2 ng/mL

• At least 3 rising PSA levels (post-radiotherapy) obtained ≥ 1 month apart, with the last PSA obtained within the past 2 months

• No metastatic disease by bone scan or abdomino-pelvic CT scan

• Group 2

• Not suitable for radical treatment at primary diagnosis

• Not planning to receive curative treatment

• Localized or metastatic disease

• No symptomatic disease requiring radiotherapy or immediate hormonal therapy

• No symptomatic disease requiring therapy

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• Not specified

Life expectancy

• At least 5 years

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No other significant comorbid condition that would limit life expectancy to < 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• At least 12 months since prior androgen deprivation therapy (ADT) administered in the neoadjuvant or concurrent (with radiotherapy) setting (group 1)

• No prior ADT (group 2)

Radiotherapy

• See Disease Characteristics

• See Endocrine therapy

Surgery

• See Disease Characteristics

Other

• No concurrent enrollment in TROG-96.01 or TROG-RADAR protocols