High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy

NCT ID: NCT00604526

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2014-12-31

Brief Summary

High dose rate (HDR) brachytherapy is a form of radiation treatment using temporary radioactive seeds. This is done by placing very tiny catheters or tubes into the prostate and then inserting temporary radioactive seeds, called Iridium 192, through these catheters. HDR brachytherapy gives precise radiation to the prostate with less radiation given to the normal tissues near the prostate. For patients who have been treated with external beam radiation to the prostate before, HDR brachytherapy can give radiation again to the prostate without exposing the normal tissues around the prostate to significantly more radiation. This may be safer than giving external beam radiation again. The purpose of this study is to test the safety of high dose rate temporary brachytherapy (HDR) for prostate cancer that has come back after external beam radiation. We want to find out what effects, good and/or bad, the treatment has on you and your recurrent prostate cancer.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Questionnaires, Iridium 192 radioactive seeds

Group Type: EXPERIMENTAL

High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds

Intervention Type: RADIATION

Pre-tx Sexual function questionnaire Quality of Life baseline, Treatment with HDR (Two days) Treatment: Iridium 192 radioactive seeds temporarily inserted into patient. Post treatment (after HDR) Month 1 (+/- 2 weeks), 3 (+/- 1 month), 6 (+/- 1 month), 9 (+/-1 month), 12 (+/- 1 month)* NCI CTC GU and GI assessment,IPSS, IIEF, PSA lab test, Prostate HRQOL

*After 1 year, will follow up with doctor about every 6 months.

Interventions

High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds

Pre-tx Sexual function questionnaire Quality of Life baseline, Treatment with HDR (Two days) Treatment: Iridium 192 radioactive seeds temporarily inserted into patient. Post treatment (after HDR) Month 1 (+/- 2 weeks), 3 (+/- 1 month), 6 (+/- 1 month), 9 (+/-1 month), 12 (+/- 1 month)* NCI CTC GU and GI assessment,IPSS, IIEF, PSA lab test, Prostate HRQOL

*After 1 year, will follow up with doctor about every 6 months.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• KPS > than or equal to 80
• Able to give informed consent
• Able to complete toxicity scales and questionnaires
• Histologically MSKCC confirmed diagnosis of recurrent prostate cancer.
• Documented history of definitive radiotherapy to the prostate gland
• IPSS of < than or equal to 15 at the time of evaluation
• PSA < than or equal to 15 ng/ml
• Organ confined disease

Exclusion Criteria

• Unable to tolerate general anesthesia
• Abnormal complete blood count. Any of the following:
• Platelet count less than 75,000/ml
• Hb level less than 10 gm/dl
• WBC less than 3.5/ml
• Abnormal coagulation profile:
• INR > 2.5
• Abnormal Liver function tests (>1.5 x normal value)
• Abnormal renal function tests (creatinine > 1.5)
• Evidence of metastatic disease (bone scan, radiographs, MRI findings)
• Prostate volume > 50 cc
• Unable to meet treatment planning criteria
• History of rectal surgery
• External beam radiation dose to the prostate > 86.4 Gy if standard treatment planning dose constraints were met
• History of inflammatory bowel disease
• Expected survival < 1 year
• Unable to undergo bone scan, CT or MRI evaluation
• Unavailable for regular follow up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoshiya Yamada, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

06-122

Identifier Type: -

Identifier Source: org_study_id