Prostate SABR With Intra-Prostatic SABR Boost

Phase 2

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT04212715
• Lead Sponsor: King Saud University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-26
• Study First Submitted: 2019-12-26
• Study First Submitted QC: 2019-12-26
• Study First Posted: 2019-12-27
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2020-01-02
• Primary Completion: 2021-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acute Toxicity	3 month after accrual is completed	To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria

Trial Locations

Locations (1)

King Saud University Medical City; 🇸🇦 Riyadh, Saudi Arabia