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Androgen Deprivation Therapy in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110162
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 4, 2005
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

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 studying how well androgen deprivation therapy works in treating patients with prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: antiandrogen therapy Drug: releasing hormone agonist therapy Procedure: orchiectomy Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
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
Study Start Date : October 2004
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Death from any cause at 8 years

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • Any age

Performance status

  • Not specified

Life expectancy

  • At least 5 years


  • Not specified


  • Not specified


  • Not specified


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


Biologic therapy

  • Not specified


  • 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)


  • See Disease Characteristics
  • See Endocrine therapy


  • See Disease Characteristics


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110162

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Australia, New South Wales
Cancer Therapy Centre at Campbelltown Hospital Recruiting
Campbelltown, New South Wales, Australia, 2560
Contact: Martin P. Berry    61-2-4636-4375   
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Contact: George Hruby, MD    61-2-9767-5112      
Nepean Cancer Care Centre at Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Contact: Viet Do    61-2-4734-3500      
Cancer Therapy Centre at Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Andrew Kneebone    6-12-9828-5282   
Sydney Cancer Centre at Royal Prince Alfred Hospital Recruiting
Sydney, New South Wales, Australia, 2050
Contact: George Hruby, MD    61-2-9515-8057   
Westmead Institute for Cancer Research at Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Sandra Turner    61-2-9845-6499      
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Lizbeth Kenny, MD    61-7-3636-8111   
Princess Alexandra Hospital Recruiting
Brisbane, Queensland, Australia, 4102
Contact: Margot Lehman    61-7-3240-6799      
Mater Adult Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Guy Bryant    6-17-3840-3255   
East Coast Cancer Centre Recruiting
Tugun, Queensland, Australia, 4224
Contact: David Christie, MD    61-7-5598-0366      
Australia, South Australia
Urological Solutions Recruiting
Ashford, South Australia, Australia, 5035
Contact: Graham Sinclair, MD    61-8-8297-3877      
Repatriation General Hospital Recruiting
Daws Park, South Australia, Australia, 5041
Contact: Alan Stapleton    61-8-8275-1927   
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Gillian M. Duchesne, MD, FRCR    61-3-9656-1004   
Geelong Hospital Recruiting
Geelong, Victoria, Australia, 3200
Contact: Michael Francis, MBBS, FRACR    6-13-5226-7644      
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jeremy Millar    61-3-9276-2337   
West Gippsland Hospital Recruiting
Warragul, Victoria, Australia, 3820
Contact: William Straffon, MD    61-3-5623-0857      
Christchurch Hospital Recruiting
Christchurch, Australia, 1
Contact: Chris Atkinson    64-3-364-0020      
New Zealand
Dunedin Hospital Recruiting
Dunedin, New Zealand
Contact: John North    64-3-474-7947   
Waikato Hospital Recruiting
Hamilton, New Zealand, 2020
Contact: Leanne Tyrie    64-7-839-8976      
Palmerston North Hospital Recruiting
Palmerston North, New Zealand
Contact: Johan S. Nel, MD    64-6-350-8430      
Sponsors and Collaborators
Peter MacCallum Cancer Centre, Australia
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Study Chair: Gillian M. Duchesne, MD, FRCR Peter MacCallum Cancer Centre, Australia

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00110162     History of Changes
Other Study ID Numbers: PMCC-VCOG-PR-0103
CDR0000413706 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 4, 2005    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: June 2009

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