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Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer


Phase 2
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the late toxicity outcomes

Outcome Description:

focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Outcome Time Frame:

6 months to 2 years

Safety Issue:

Yes

Principal Investigator

Michael Zelefsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-056

NCT ID:

NCT01354951

Start Date:

May 2011

Completion Date:

May 2014

Related Keywords:

  • Prostate Cancer
  • Focal Brachytherapy
  • Endorectal coil MRI
  • Quality of Life
  • 11-056
  • Prostatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021