Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00110162
- Lead Sponsor
- Peter MacCallum Cancer Centre, Australia
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death from any cause at 8 years
- Secondary Outcome Measures
Name Time Method Cancer specific survival Clinical progression Time to first androgen independence Complication rate incidence and timing (e.g., cord compression, pathological fracture) Treatment-related morbidity (including cognitive, osteoporosis) Prognostic factors for progression (delayed group) EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years CTC v3.0 Survival endpoints: actuarial analysis at eight years Morbidity continuously
Trial Locations
- Locations (20)
Sydney Cancer Centre at Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Cancer Therapy Centre at Campbelltown Hospital
🇦🇺Campbelltown, New South Wales, Australia
Nepean Cancer Care Centre at Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Repatriation General Hospital
🇦🇺Daws Park, South Australia, Australia
Christchurch Hospital
🇦🇺Christchurch, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
West Gippsland Hospital
🇦🇺Warragul, Victoria, Australia
Palmerston North Hospital
🇳🇿Palmerston North, New Zealand
Geelong Hospital
🇦🇺Geelong, Victoria, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Waikato Hospital
🇳🇿Hamilton, New Zealand
Cancer Therapy Centre at Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
East Coast Cancer Centre
🇦🇺Tugun, Queensland, Australia
Urological Solutions
🇦🇺Ashford, South Australia, Australia
Dunedin Hospital
🇳🇿Dunedin, New Zealand