High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
January 4, 2016 updated by: Memorial Sloan Kettering Cancer Center
Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yoshiya Yamada, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 8, 2008
First Submitted That Met QC Criteria
January 28, 2008
First Posted (Estimate)
January 30, 2008
Study Record Updates
Last Update Posted (Estimate)
January 5, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
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.