Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study

King Saud University1 site in 1 country30 target enrollmentDecember 26, 2019

ConditionsProstate Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: King Saud University
Enrollment: 30
Locations: 1
Primary Endpoint: Acute Toxicity
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.

Registry

clinicaltrials.gov

Start Date

December 26, 2019

End Date

December 2026

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

King Saud University

Responsible Party

Principal Investigator

Dr. Yasir Alayed

Consultant and Assistant Professor

King Saud University

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed prostate adenocarcinoma
•High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA \> 20 ng/mL
•Willing to give informed consent to participate in this clinical trial

Exclusion Criteria

•Prior pelvic radiotherapy
•Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
•Contraindication to prostate MRI
•No evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
•Definitive extrapelvic nodal or distant metastatic disease on staging investigations.