Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
18 Years
85 Years
Male
Prostate Cancer
Trial Information
Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
assess feasibility & toxicity of HDR as salvage ther for local recurrent prostate cancer after ext beam radiotherapy. QOL instruments and questionnaires including the MSK prostate QOL instrument, the IIEF, IPSS , & the NCI CTC is used to assess toxicity.
Outcome Time Frame:
conclusion of study
Safety Issue:
Yes
Principal Investigator
Yoshiya Yamada, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
06-122
NCT ID:
NCT00604526
Start Date:
September 2006
Completion Date:
September 2013
Related Keywords:
- Prostate Cancer
- recurrent
- Prostatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
