Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer (J-POPS)

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status: Completed

Conditions: Prostate Cancer

Treatments: Radiation: Permanent iodine-125 (Brachytherapy)

Study type: Observational

Funder types: Other

Identifiers

NCT00534196

TUSM-BRI-GU-04-01

CDR0000562726

Details and patient eligibility

About

RATIONALE: Implant radiation therapy delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial is studying the side effects and how well implant radiation therapy using radioactive iodine works in treating patients with localized prostate cancer.

Full description

OBJECTIVES:

• To determine the efficacy of permanent brachytherapy with iodine I 125 seeds in patients with localized prostate cancer.
• To determine the safety of this therapy in these patients.

OUTLINE: This is a multicenter study.

Patients undergo permanent brachytherapy seed implantation comprised of iodine I 125 into the prostate. Some patients may receive combination treatment (e.g., external beam radiation therapy (EBRT) or hormone therapy in addition to brachytherapy).

Quality of life and the International Prostate Symptom Score (IPSS) is assessed and compared.

Enrollment: 6,927 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Clinically and histologically confirmed localized prostate cancer

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• No prior or concurrent surgery
• No prior or concurrent radiotherapy
• Prior chemotherapy, hormonal therapy, and biologic therapy allowed

Trial design

6,927 participants in 1 patient group

Group under operation of brachytherapy

Description:

Patients with histologically confirmed adenocarcinoma of the prostate and who are planning to undergo brachytherapy with PI (permanent iodine) or combination of PI with other tratement.

Treatment:

Radiation: Permanent iodine-125 (Brachytherapy)