Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

NCT01540994 | Completed Results DMC

• 1 other identifier: 101091
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Neoplasm

Keywords

Neoplasms; Urogenital neoplasm; Genital neoplasms, male

Outcome Measures

Primary Outcomes (1)

• Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales.

  Acute and late genitourinary and lower gastrointestinal toxicity will be evaluated using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales, which range from 0-5, where a high score corresponds to a worse outcome/worse toxicity. Toxicity will be measured weekly during radiation, and every 6-12 months following radiation through patient interview. The acute toxicity score will be defined as the highest score obtained from measurements taken during radiation for each participant. The late toxicity score will be defined as the highest score obtained from measurements taken following completion of radiation for each participant.

  Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.

Secondary Outcomes (1)

• Rate of Biochemical Disease-free Status

  mean 41 months (range 3-84 months)

Study Arms (1)

Stereotactic Body Radiation Therapy

EXPERIMENTAL

Stereotactic Body Radiation Therapy

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Stereotactic Body Radiation Therapy

Stereotactic Body Radiation Therapy

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sharp HealthCare: lead

Study Sites (1)

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Urogenital Neoplasms; Genital Neoplasms, Male

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Geoffrey Weinstein
• Organization: Sharp Healthcare

geoffrey.weinstein@sharp.com

858-939-5010

Study Officials

• Geoffrey Weinstein, M.D.

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Radiation Oncology

Model Details: Radiotherapy: phase 1/2 (but no drug, biological/vaccine or combination product used)

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 29, 2012
• Study Start: January 1, 2011
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2025-01

Locations

US (1)