Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage

San Diego Radiosurgery1 site in 1 country50 target enrollmentAugust 2009

ConditionsProstate Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: San Diego Radiosurgery
Enrollment: 50
Locations: 1
Primary Endpoint: PSA decline measured through laboratory testing.
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.

The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

December 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

San Diego Radiosurgery

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed adenocarcinoma of the prostate
•Gleason score ≤ 6 and low volume Gleason 7 (3+4)
•PSA \< 10
•Clinical Stage of T2a or less
•Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

•Prior radiation treatment for prostate cancer
•Gleason score \> 7
•PSA \> 10
•Clinical Stage of T2b or greater

Outcomes

Primary Outcomes

PSA decline measured through laboratory testing.

Time Frame: One month following radiosurgery through 5 year follow up

Secondary Outcomes

Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.(One month following radiosurgery through 5 years follow up.)