Status:
UNKNOWN
Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE3
Brief 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 studyin...
Detailed Description
OBJECTIVES: Primary * Compare overall survival (with acceptable morbidity) of patients with prostate cancer treated with delayed vs immediate androgen deprivation therapy (ADT). Secondary * Compar...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00110162
Start Date
October 1 2004
Last Update
August 7 2013
Active Locations (20)
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1
Cancer Therapy Centre at Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
2
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
3
Nepean Cancer Care Centre at Nepean Hospital
Kingswood, New South Wales, Australia, 2747
4
Cancer Therapy Centre at Liverpool Hospital
Liverpool, New South Wales, Australia, 2170