Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
NCT ID: NCT00110162
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
2000 participants
INTERVENTIONAL
2004-10-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer.
Detailed Description
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Primary
* Compare overall survival (with acceptable morbidity) of patients with prostate cancer treated with delayed vs immediate androgen deprivation therapy (ADT).
Secondary
* Compare cancer-specific survival of patients treated with these regimens.
* Compare clinical progression in patients treated with these regimens.
* Compare time to first androgen independence in patients treated with these regimens.
* Compare complication rate incidence and timing (e.g., cord compression or pathological failure) in patients treated with these regimens.
* Compare treatment-related morbidity (including cognitive morbidity or osteoporosis) in patients treated with these regimens.
* Compare quality of life of patients treated with these regimens.
* Determine prognostic factors for progression in patients treated with delayed ADT.
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.
* Arm I (delayed ADT): Beginning at least 2 years after study entry or after exhibiting evidence of significant disease progression\*, patients receive either continuous ADT OR intermittent ADT comprising either bilateral orchiectomy OR luteinizing hormone-releasing hormone agonist with or without oral antiandrogen therapy.
* Arm II (immediate ADT): Beginning immediately after randomization, patients receive either continuous ADT OR intermittent ADT as in arm I.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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antiandrogen therapy
releasing hormone agonist therapy
orchiectomy
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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Peter MacCallum Cancer Centre, Australia
OTHER
Principal Investigators
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Gillian M. Duchesne, MD, FRCR
Role: STUDY_CHAIR
Peter MacCallum Cancer Centre, Australia
Locations
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Cancer Therapy Centre at Campbelltown Hospital
Campbelltown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Nepean Cancer Care Centre at Nepean Hospital
Kingswood, New South Wales, Australia
Cancer Therapy Centre at Liverpool Hospital
Liverpool, New South Wales, Australia
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
East Coast Cancer Centre
Tugun, Queensland, Australia
Urological Solutions
Ashford, South Australia, Australia
Repatriation General Hospital
Daws Park, South Australia, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Geelong Hospital
Geelong, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
West Gippsland Hospital
Warragul, Victoria, Australia
Christchurch Hospital
Christchurch, , Australia
Dunedin Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Palmerston North Hospital
Palmerston North, , New Zealand
Countries
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Facility Contacts
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Martin P. Berry
Role: primary
George Hruby, MD
Role: primary
Viet Do
Role: primary
Andrew Kneebone
Role: primary
George Hruby, MD
Role: primary
Sandra Turner
Role: primary
Lizbeth Kenny, MD
Role: primary
Margot Lehman
Role: primary
Guy Bryant
Role: primary
David Christie, MD
Role: primary
Graham Sinclair, MD
Role: primary
Alan Stapleton
Role: primary
Gillian M. Duchesne, MD, FRCR
Role: primary
Michael Francis, MBBS, FRACR
Role: primary
Jeremy Millar
Role: primary
William Straffon, MD
Role: primary
Chris Atkinson
Role: primary
John North
Role: primary
Leanne Tyrie
Role: primary
Johan S. Nel, MD
Role: primary
References
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Duchesne GM, Woo HH, King M, Bowe SJ, Stockler MR, Ames A, D'Este C, Frydenberg M, Loblaw A, Malone S, Millar J, Tai KH, Turner S. Health-related quality of life for immediate versus delayed androgen-deprivation therapy in patients with asymptomatic, non-curable prostate cancer (TROG 03.06 and VCOG PR 01-03 [TOAD]): a randomised, multicentre, non-blinded, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1192-1201. doi: 10.1016/S1470-2045(17)30426-6. Epub 2017 Jul 28.
Duchesne GM, Woo HH, Bassett JK, Bowe SJ, D'Este C, Frydenberg M, King M, Ledwich L, Loblaw A, Malone S, Millar J, Milne R, Smith RG, Spry N, Stockler M, Syme RA, Tai KH, Turner S. Timing of androgen-deprivation therapy in patients with prostate cancer with a rising PSA (TROG 03.06 and VCOG PR 01-03 [TOAD]): a randomised, multicentre, non-blinded, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):727-737. doi: 10.1016/S1470-2045(16)00107-8. Epub 2016 May 4.
Other Identifiers
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CDR0000413706
Identifier Type: REGISTRY
Identifier Source: secondary_id
PMCC-TROG-0306
Identifier Type: -
Identifier Source: secondary_id
PMCC-VCOG-PR-0103
Identifier Type: -
Identifier Source: org_study_id