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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (20 locations)

    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