Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer
N/A
79 Years
Male
Prostate Cancer
Trial Information
Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer
OBJECTIVES:
Primary
- Compare time to loss of androgen dependence, based on serum prostate-specific antigen
failure, in patients with newly diagnosed stage III or IV prostate cancer treated with
intermittent vs continuous androgen suppression comprising cyproterone acetate.
- Compare time to treatment failure (subjective or objective progression) in patients
treated with these regimens.
- Compare quality of life of patients treated with these regimens.
- Compare survival of patients treated with these regimens.
Secondary
- Compare the side effects in patients treated with these regimens.
- Determine the first and total therapy-free intervals in patients treated with
intermittent cyproterone acetate.
OUTLINE: This is a randomized, multicenter study.
All patients receive cyproterone acetate daily for 16 weeks. Patients also receive monthly
injections of luteinizing hormone-releasing hormone (LHRH) agonist beginning in week 2 and
continuing for 14 weeks. Patients with a prostate-specific antigen (PSA) level of ≤ 4 ng/mL
and who are asymptomatic at 14 weeks are randomized to 1 of 2 treatment arms.
- Arm I (continuous maximum-androgen blockade): Patients receive cyproterone acetate
daily and monthly LHRH agonist depot injections in the absence of disease progression
or unacceptable toxicity. Patients may also undergo orchidectomy.
Quality of life is assessed every 6 months for 2 years and then annually thereafter.
- Arm II (intermittent treatment): Patients are observed after randomization. Treatment
with daily cyproterone acetate resumes if symptoms demand hormone treatment and patient
has any PSA level OR if patient is asymptomatic and has a PSA level ≥ 20 ng/mL.
Treatment continues in the absence of disease progression or unacceptable toxicity. If
after 9 months of treatment, a PSA level of ≤ 4 ng/mL is not achieved or the patient
remains symptomatic, treatment is discontinued.
Quality of life is assessed every 6 months and when therapy is restarted.
Pain and performance status are assessed at each visit in both treatment arms.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- T3 -T4, M0-M1 (stage III or IV disease)
- Prostate-specific antigen level ≥ 4 ng/mL and ≤ 100 ng/mL
PATIENT CHARACTERISTICS:
- Performance status 0-2
- Normal liver function
- No other neoplasia (except skin, excluding melanoma)
- No expected difficulties of follow-up related to psychiatric disorders, marked
senility, or too large a distance between patient's home and investigator's center
- No severe chronic disease
PRIOR CONCURRENT THERAPY:
- No prior hormonal therapy or chemotherapy
- No prior surgery (radical prostatectomy), except transurethral resection, for M0
patients
- No prior radiotherapy to the primary tumor for M0 patients
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Time to loss of androgen-dependence, based on serum prostate-specific antigen (PSA) failure according to protocol definition
Safety Issue:
No
Principal Investigator
R. T. Oliver, MD
Investigator Role:
Study Chair
Investigator Affiliation:
St. Bartholomew's Hospital
Authority:
Unspecified
Study ID:
CDR0000495321
NCT ID:
NCT00363285
Start Date:
January 2003
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
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