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Androgen Deprivation Therapy in Treating Patients With Prostate Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00110162
First received: May 3, 2005
Last updated: August 6, 2013
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: antiandrogen therapy
Drug: releasing hormone agonist therapy
Procedure: orchiectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Death from any cause at 8 years

Secondary Outcome Measures:
  • Cancer specific survival
  • Clinical progression
  • Time to first androgen independence
  • Complication rate incidence and timing (e.g., cord compression, pathological fracture)
  • Treatment-related morbidity (including cognitive, osteoporosis)
  • Prognostic factors for progression (delayed group)
  • EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years
  • CTC v3.0 Survival endpoints: actuarial analysis at eight years
  • Morbidity continuously

Estimated Enrollment: 2000
Study Start Date: October 2004
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110162

Locations
Australia, New South Wales
Cancer Therapy Centre at Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Nepean Cancer Care Centre at Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Cancer Therapy Centre at Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
East Coast Cancer Centre
Tugun, Queensland, Australia, 4224
Australia, South Australia
Urological Solutions
Ashford, South Australia, Australia, 5035
Repatriation General Hospital
Daws Park, South Australia, Australia, 5041
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Geelong Hospital
Geelong, Victoria, Australia, 3200
Alfred Hospital
Melbourne, Victoria, Australia, 3004
West Gippsland Hospital
Warragul, Victoria, Australia, 3820
Australia
Christchurch Hospital
Christchurch, Australia, 1
New Zealand
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital
Hamilton, New Zealand, 2020
Palmerston North Hospital
Palmerston North, New Zealand
Sponsors and Collaborators
Peter MacCallum Cancer Centre, Australia
Investigators
Study Chair: Gillian M. Duchesne, MD, FRCR Peter MacCallum Cancer Centre, Australia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00110162     History of Changes
Other Study ID Numbers: PMCC-VCOG-PR-0103  CDR0000413706  PMCC-TROG-0306 
Study First Received: May 3, 2005
Last Updated: August 6, 2013

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Androgens
Androgen Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormone Antagonists

ClinicalTrials.gov processed this record on February 20, 2017