A Phase III, Multicenter, Randomized, Controlled Study of Neoadjuvant LHRH-agonist Therapy and Permanent I-125 Implantation With vs. Without Adjuvant LHRH-agonist Therapy in Patients With Untreated Intermediate-risk Prostate Cancer.
20 Years
75 Years
Male
Prostate Cancer
Trial Information
A Phase III, Multicenter, Randomized, Controlled Study of Neoadjuvant LHRH-agonist Therapy and Permanent I-125 Implantation With vs. Without Adjuvant LHRH-agonist Therapy in Patients With Untreated Intermediate-risk Prostate Cancer.
OBJECTIVES:
- To evaluate the biochemical progression-free survival (PFS), overall survival, clinical
PFS, and disease-free survival of patients with previously untreated intermediate-risk
prostate cancer treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)
agonist therapy and permanent iodine I 125 implantation with vs without adjuvant LHRH
agonist therapy.
- To determine the non-adaptive interval to salvage therapy in patients treated with
these regimens.
- To determine the safety of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive neoadjuvant luteinizing hormone-releasing hormone (LHRH)
agonist therapy for up to 3 months and undergo permanent iodine I 125 implantation.
Patients then receive adjuvant LHRH agonist therapy for up to 9 months.
- Arm II: Patients receive neoadjuvant LHRH agonist therapy and undergo permanent iodine
I 125 implantation as in arm I.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed prostate cancer
- Previously untreated disease
- Intermediate-risk disease, as defined by the following:
- Clinical stage < T2c
- Prostate-specific antigen (PSA) ≤ 20 ng/mL
- Gleason score < 8
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- Leukocyte count ≥ 2,000/uL
- Hemoglobin ≥ 10.0 g/dL
- Platelet count ≥ 100,000/uL
- Serum creatinine ≤ 2.0 mg/dL
- ALT and AST ≤ 100 IU/L
- No other cancer requiring treatment
- No poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm Hg)
- No severe psychiatric disorders, including schizophrenia or dementia
- No poorly controlled diabetes
- Considered appropriate for study participation, as determined by the Principal
Investigator or Clinical Investigator
PRIOR CONCURRENT THERAPY:
- No prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy)
- No prior surgery for prostate cancer
- No concurrent steroid drugs (except for ointment)
- No other concurrent antiandrogen therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Biochemical progression-free survival (PFS)
Safety Issue:
No
Principal Investigator
Shin Egawa, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jikei University School of Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000593653
NCT ID:
NCT00664456
Start Date:
April 2008
Completion Date:
Related Keywords:
- Prostate Cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage I prostate cancer
- Prostatic Neoplasms
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