Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Prostatic Neoplasm Clinical Trial

Official title:

Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540994
• Other study ID #: 101091
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2011
• Est. completion date: April 5, 2019

Study information

• Verified date: September 2019
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.

Exclusion Criteria:

• Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.

Related Conditions & MeSH terms

• Neoplasms
• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Radiation:
• radiation therapy
Stereotactic Body Radiation Therapy

Locations

Country	Name	City	State
United States	Sharp Memorial Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sharp HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute and late toxicity to the GU and GI systems	acute and late toxicity to the GU and GI systems based on the RTOG definitions will be compared to those of standard radiation therapy.	1 year follow-up
Secondary	Drop in the PSA (biochemical marker)	One year biochemical control rate of >90%.	1 year follow-up