- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00604526
High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Questionnaires, 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: conclusion of study
|
conclusion of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess biochemical or PSA relapse free survival.
Time Frame: conclusion of study
|
conclusion of study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yoshiya Yamada, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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