Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00969202
• Other study ID #: SDRS0001
• Status: Recruiting
• Phase: Phase 1
• First received: August 28, 2009
• Last updated: November 17, 2015
• Start date: August 2009
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: San Diego Radiosurgery
• Contact: Jennifer Joiner
• Phone: 760-739-3185
• Email: Jennifer.joiner[@]palomarhealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic Radiosurgery using the Novalis Tx
Five treatments given every other day.

Locations

Country	Name	City	State
United States	San Diego Radiosurgery at Palomar Medical Center	Escondido	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego Radiosurgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA decline measured through laboratory testing.		One month following radiosurgery through 5 year follow up	No
Secondary	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.	No