- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00110162
Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Christchurch, Australia, 1
- Recruiting
- Christchurch Hospital
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Contact:
- Chris Atkinson
- Phone Number: 64-3-364-0020
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New South Wales
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Campbelltown, New South Wales, Australia, 2560
- Recruiting
- Cancer Therapy Centre at Campbelltown Hospital
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Contact:
- Martin P. Berry
- Phone Number: 61-2-4636-4375
- Email: martin.berry@swsahs.nsw.gov.au
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Concord, New South Wales, Australia, 2139
- Recruiting
- Concord Repatriation General Hospital
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Contact:
- George Hruby, MD
- Phone Number: 61-2-9767-5112
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Kingswood, New South Wales, Australia, 2747
- Recruiting
- Nepean Cancer Care Centre at Nepean Hospital
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Contact:
- Viet Do
- Phone Number: 61-2-4734-3500
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Liverpool, New South Wales, Australia, 2170
- Recruiting
- Cancer Therapy Centre at Liverpool Hospital
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Contact:
- Andrew Kneebone
- Phone Number: 6-12-9828-5282
- Email: andrew.kneebone@swsahs.gov.au
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Sydney, New South Wales, Australia, 2050
- Recruiting
- Sydney Cancer Centre at Royal Prince Alfred Hospital
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Contact:
- George Hruby, MD
- Phone Number: 61-2-9515-8057
- Email: ghruby@email.cs.nsw.gov.au
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Westmead, New South Wales, Australia, 2145
- Recruiting
- Westmead Institute for Cancer Research at Westmead Hospital
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Contact:
- Sandra Turner
- Phone Number: 61-2-9845-6499
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Queensland
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Brisbane, Queensland, Australia, 4102
- Recruiting
- Princess Alexandra Hospital
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Contact:
- Margot Lehman
- Phone Number: 61-7-3240-6799
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Brisbane, Queensland, Australia, 4029
- Recruiting
- Royal Brisbane and Women's Hospital
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Contact:
- Lizbeth Kenny, MD
- Phone Number: 61-7-3636-8111
- Email: lizkenny@bigpond.net.au
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South Brisbane, Queensland, Australia, 4101
- Recruiting
- Mater Adult Hospital
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Contact:
- Guy Bryant
- Phone Number: 6-17-3840-3255
- Email: guy-bryant@health.qld.gov.au
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Tugun, Queensland, Australia, 4224
- Recruiting
- East Coast Cancer Centre
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Contact:
- David Christie, MD
- Phone Number: 61-7-5598-0366
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South Australia
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Ashford, South Australia, Australia, 5035
- Recruiting
- Urological Solutions
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Contact:
- Graham Sinclair, MD
- Phone Number: 61-8-8297-3877
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Daws Park, South Australia, Australia, 5041
- Recruiting
- Repatriation General Hospital
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Contact:
- Alan Stapleton
- Phone Number: 61-8-8275-1927
- Email: alan.stapleton@rgh.sa.gov.au
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Victoria
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East Melbourne, Victoria, Australia, 3002
- Recruiting
- Peter MacCallum Cancer Centre
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Contact:
- Gillian M. Duchesne, MD, FRCR
- Phone Number: 61-3-9656-1004
- Email: gillian.duchesne@petermac.org
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Geelong, Victoria, Australia, 3200
- Recruiting
- Geelong Hospital
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Contact:
- Michael Francis, MBBS, FRACR
- Phone Number: 6-13-5226-7644
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Melbourne, Victoria, Australia, 3004
- Recruiting
- Alfred Hospital
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Contact:
- Jeremy Millar
- Phone Number: 61-3-9276-2337
- Email: jeremy.millar@med.monash.edu.au
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Warragul, Victoria, Australia, 3820
- Recruiting
- West Gippsland Hospital
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Contact:
- William Straffon, MD
- Phone Number: 61-3-5623-0857
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Dunedin, New Zealand
- Recruiting
- Dunedin Hospital
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Contact:
- John North
- Phone Number: 64-3-474-7947
- Email: johnn@healthotago.co.nz
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Hamilton, New Zealand, 2020
- Recruiting
- Waikato Hospital
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Contact:
- Leanne Tyrie
- Phone Number: 64-7-839-8976
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Palmerston North, New Zealand
- Recruiting
- Palmerston North Hospital
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Contact:
- Johan S. Nel, MD
- Phone Number: 64-6-350-8430
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Death from any cause at 8 years
|
Secondary Outcome Measures
Outcome Measure |
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Cancer specific survival
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Clinical progression
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Time to first androgen independence
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Complication rate incidence and timing (e.g., cord compression, pathological fracture)
|
Treatment-related morbidity (including cognitive, osteoporosis)
|
Prognostic factors for progression (delayed group)
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EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years
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CTC v3.0 Survival endpoints: actuarial analysis at eight years
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Morbidity continuously
|
Collaborators and Investigators
Investigators
- Study Chair: Gillian M. Duchesne, MD, FRCR, Peter MacCallum Cancer Centre, Australia
Publications and helpful links
General Publications
- 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. Erratum In: Lancet Oncol. 2016 Jun;17 (6):e223. Lancet Oncol. 2017 Sep;18(9):e510.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMCC-VCOG-PR-0103
- CDR0000413706 (Registry Identifier: PDQ (Physician Data Query))
- PMCC-TROG-0306
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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