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Sponsored by: |
Peter MacCallum Cancer Centre, Australia |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00110162 |
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 |
Procedure: antiandrogen therapy Procedure: orchiectomy Procedure: releasing hormone agonist therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA |
Estimated Enrollment: | 2000 |
Study Start Date: | October 2004 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized, controlled study. Patients in group 1 are stratified according to prior therapy (prostatectomy vs radiotherapy vs prostatectomy and radiotherapy), relapse-free interval (< 2 years vs ≥ 2 years), type of planned androgen deprivation therapy (ADT) (continuous vs intermittent), and participating center. Patients in group 2 are stratified according to type of planned ADT (continuous vs intermittent), disease type (localized vs metastatic), and participating center. Patients in both groups are randomized to 1 of 2 treatment arms.
NOTE: *Patients in group 1 begin delayed ADT at least 2 years after study entry unless 1 of the following clinical criteria is present: prostate-specific antigen (PSA) doubling time of < 12 months with PSA ≥ 10 ng/mL OR PSA doubling time of ≤ 6 months based on 3 consecutive measurements obtained ≥ 2 months apart OR development of metastases or symptoms. Patients in group 2 begin delayed ADT at least 2 years after study entry unless 1 of the following clinical criteria is present: development of symptoms OR PSA ≥ 60 ng/mL OR PSA doubling time of ≤ 6 months based on 3 consecutive measurements obtained ≥ 2 months apart.
After 9 months of ADT, all patients are assessed for response. Patients with PSA < 4 ng/mL may discontinue ADT. These patients are followed every 3 months. Treatment may be restarted when PSA is > 20 ng/mL OR PSA is > the PSA level at study entry OR at clinical progression.
Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 3 years.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter at the discretion of the principal investigator.
PROJECTED ACCRUAL: A total of 300-2,000 patients will be accrued for this study within 2-5 years.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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:
Group 2
Localized or metastatic disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Australia | |
Christchurch Hospital | Recruiting |
Christchurch, Australia, 1 | |
Contact: Chris Atkinson 64-3-364-0020 | |
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 martin.berry@swsahs.nsw.gov.au | |
Cancer Therapy Centre at Liverpool Hospital | Recruiting |
Liverpool, New South Wales, Australia, 2170 | |
Contact: Andrew Kneebone 6-12-9828-5282 andrew.kneebone@swsahs.gov.au | |
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 | |
Sydney Cancer Centre at Royal Prince Alfred Hospital | Recruiting |
Sydney, New South Wales, Australia, 2050 | |
Contact: George Hruby, MD 61-2-9515-8057 ghruby@email.cs.nsw.gov.au | |
Westmead Institute for Cancer Research at Westmead Hospital | Recruiting |
Westmead, New South Wales, Australia, 2145 | |
Contact: Sandra Turner 61-2-9845-6499 | |
Australia, Queensland | |
East Coast Cancer Centre | Recruiting |
Tugun, Queensland, Australia, 4224 | |
Contact: David Christie, MD 61-7-5598-0366 | |
Mater Adult Hospital | Recruiting |
South Brisbane, Queensland, Australia, 4101 | |
Contact: Guy Bryant 6-17-3840-3255 guy-bryant@health.qld.gov.au | |
Princess Alexandra Hospital | Recruiting |
Brisbane, Queensland, Australia, 4102 | |
Contact: Margot Lehman 61-7-3240-6799 | |
Royal Brisbane and Women's Hospital | Recruiting |
Brisbane, Queensland, Australia, 4029 | |
Contact: Lizbeth Kenny, MD 61-7-3636-8111 lizkenny@bigpond.net.au | |
Australia, South Australia | |
Repatriation General Hospital | Recruiting |
Daws Park, South Australia, Australia, 5041 | |
Contact: Alan Stapleton 61-8-8275-1927 alan.stapleton@rgh.sa.gov.au | |
Urological Solutions | Recruiting |
Ashford, South Australia, Australia, 5035 | |
Contact: Graham Sinclair, MD 61-8-8297-3877 | |
Australia, Victoria | |
Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3004 | |
Contact: Jeremy Millar 61-3-9276-2337 jeremy.millar@med.monash.edu.au | |
Geelong Hospital | Recruiting |
Geelong, Victoria, Australia, 3200 | |
Contact: Michael Francis, MBBS, FRACR 6-13-5226-7644 | |
Peter MacCallum Cancer Centre | Recruiting |
East Melbourne, Victoria, Australia, 3002 | |
Contact: Gillian M. Duchesne, MD, FRCR 61-3-9656-1004 gillian.duchesne@petermac.org | |
West Gippsland Hospital | Recruiting |
Warragul, Victoria, Australia, 3820 | |
Contact: William Straffon, MD 61-3-5623-0857 | |
New Zealand | |
Dunedin Hospital | Recruiting |
Dunedin, New Zealand | |
Contact: John North 64-3-474-7947 johnn@healthotago.co.nz | |
Palmerston North Hospital | Recruiting |
Palmerston North, New Zealand | |
Contact: Johan S. Nel, MD 64-6-350-8430 | |
Waikato Hospital | Recruiting |
Hamilton, New Zealand, 2020 | |
Contact: Leanne Tyrie 64-7-839-8976 |
Study Chair: | Gillian M. Duchesne, MD, FRCR | Peter MacCallum Cancer Centre, Australia |
Study ID Numbers: | CDR0000413706, PMCC-VCOG-PR-0103, PMCC-TROG-0306 |
Study First Received: | May 3, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00110162 |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer |
stage III prostate cancer stage IV prostate cancer recurrent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site |