Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
Recruitment status was Recruiting
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.
Drug: antiandrogen therapy
Drug: releasing hormone agonist therapy
|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|
- Death from any cause at 8 years [ Designated as safety issue: No ]
- Cancer specific survival [ Designated as safety issue: No ]
- Clinical progression [ Designated as safety issue: No ]
- Time to first androgen independence [ Designated as safety issue: No ]
- Complication rate incidence and timing (e.g., cord compression, pathological fracture) [ Designated as safety issue: No ]
- Treatment-related morbidity (including cognitive, osteoporosis) [ Designated as safety issue: No ]
- Prognostic factors for progression (delayed group) [ Designated as safety issue: No ]
- EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years [ Designated as safety issue: No ]
- CTC v3.0 Survival endpoints: actuarial analysis at eight years [ Designated as safety issue: No ]
- Morbidity continuously [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- Compare overall survival (with acceptable morbidity) of patients with prostate cancer treated with delayed vs immediate androgen deprivation therapy (ADT).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110162
|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 email@example.com|
|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 firstname.lastname@example.org|
|Sydney Cancer Centre at Royal Prince Alfred Hospital||Recruiting|
|Sydney, New South Wales, Australia, 2050|
|Contact: George Hruby, MD 61-2-9515-8057 email@example.com|
|Westmead Institute for Cancer Research at Westmead Hospital||Recruiting|
|Westmead, New South Wales, Australia, 2145|
|Contact: Sandra Turner 61-2-9845-6499|
|Royal Brisbane and Women's Hospital||Recruiting|
|Brisbane, Queensland, Australia, 4029|
|Contact: Lizbeth Kenny, MD 61-7-3636-8111 firstname.lastname@example.org|
|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 email@example.com|
|East Coast Cancer Centre||Recruiting|
|Tugun, Queensland, Australia, 4224|
|Contact: David Christie, MD 61-7-5598-0366|
|Australia, South Australia|
|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 firstname.lastname@example.org|
|Peter MacCallum Cancer Centre||Recruiting|
|East Melbourne, Victoria, Australia, 3002|
|Contact: Gillian M. Duchesne, MD, FRCR 61-3-9656-1004 email@example.com|
|Geelong, Victoria, Australia, 3200|
|Contact: Michael Francis, MBBS, FRACR 6-13-5226-7644|
|Melbourne, Victoria, Australia, 3004|
|Contact: Jeremy Millar 61-3-9276-2337 firstname.lastname@example.org|
|West Gippsland Hospital||Recruiting|
|Warragul, Victoria, Australia, 3820|
|Contact: William Straffon, MD 61-3-5623-0857|
|Christchurch, Australia, 1|
|Contact: Chris Atkinson 64-3-364-0020|
|Dunedin, New Zealand|
|Contact: John North 64-3-474-7947 email@example.com|
|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|
|Study Chair:||Gillian M. Duchesne, MD, FRCR||Peter MacCallum Cancer Centre, Australia|