Clinical trial NCT01354951: Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer
Official title: Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Focal Brachytherapy
Endorectal coil MRI
Quality of Life
11-056
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: M.D. Anderson Cancer Center
name: Northwell Health
First posted: 2011-05-17
Enrollment: 3
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: To Assess the Late Toxicity Outcomes
timeFrame: 6 months to 2 years
Secondary outcomes:
measure: To Evaluate the Local Tumor Control After Focal Brachytherapy
timeFrame: 12 and 24 months
measure: To Evaluate the Change From Baseline in QOL Indicators
timeFrame: baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment
measure: To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes
timeFrame: 2 years
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: North Shore LIJ
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Zelefsky, MD
role: PRINCIPAL_INVESTIGATOR
References: