Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer

• Status: Active, not recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Luteinizing hormone-releasing hormone agonists may lessen the amount of androgens made by the body. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving luteinizing hormone-releasing hormone agonist together with an iodine I 125 implant may be an effective treatment for patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying how well giving luteinizing hormone-releasing hormone agonist therapy together with an iodine I 125 implant works with or without additional luteinizing hormone-releasing hormone agonist therapy in treating patients with previously untreated prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Translational Research Informatics Center, Kobe, Hyogo, Japan
• Collaborator: The Jikei University School of Medicine
• Treatments: Cadexomer iodine; Iodine; Prolactin Release-Inhibiting Factors

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 ≥ 3,000/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