Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer
Stopped early · Phase 2
Conditions studied: Prostate Cancer
In brief
The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer. The study is also looking at how useful focal brachytherapy will be in treating prostate cancer. Additionally, the investigators would like to see how this type of treatment impacts quality of life.
Key facts
- Study ID
- NCT01354951
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 3
- Starts
- 2011-05-01
- Expected to finish
- 2017-10-06
- Last updated by the study team
- 2018-10-19
Who can join
Age: 21 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Men ≥ 21 years of age with a life expectancy estimated to be > 10-years.
- Diagnosis of adenocarcinoma of the prostate confirmed by MSKCC or participating site pathology review.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prostate cancer clinical stage T1c-T2a
- PSA < 10ng/mL (this will be the PSA level prompting the prostate biopsy)
- MRI evidence of one-sided disease performed within 3 months of registration
- Prostate size <60 cc at time of treatment- if the prostate is larger, hormonal therapy is allowed to achieve the required size Screening biopsy parameters:
- Minimum of 10 biopsy cores
- Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
- Unilateral cancer (only right-sided or left-sided, not bilateral)
- No more than 50 % cancer in any one biopsy core
- No more than 25 % of cores containing cancer
- Repeat transrectal or transperineal prostate biopsy that must meet the following parameters:
- Minimum of 12 biopsy cores
- Unilateral cancer (only right-sided or left-sided, not bilateral)
- Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
- No more than 50 % cancer in any one biopsy core
- No more than 25 % of cores containing cancer
- Subject Exclusion Criteria:
- Medically unfit for anesthesia
- Evidence or suspicion of extracapsular extension on MRI
- IPSS score > 18
- Unable to receive MRI
- Prior radiotherapy for the current disease
Where it is running
- North Shore LIJ — New Hyde Park, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Md Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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