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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00604526

06-122

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

Male

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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