Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05613023

A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT

Conditions: Prostate Cancer

Sex: Male
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 536
Sponsor: Institute of Cancer Research, United Kingdom

Location: United Kingdom

Summary

This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer.

Eligibility Criteria

Inclusion Criteria:Aged ≥ 18 years at randomisationHistopathological confirmation of prostate adenocarcinoma with Gleason/ISUP grade group scoring within twelve months of randomisation (unless otherwise discussed with the CI or co-Clinical Leads)Patients planned for 12-36 months androgen deprivation therapyHigh risk localised prostate cancer as defined byGleason 8-10 (grade groups 4 and 5) and/orStage T3a/b or T4 and/orPSA > 20ng/ml (or >10 ng/ml for patients on 5-alpha reductase inhibitors)Multi-parametric MRI of the pelvis- to include at least one functional MRI sequence in addition to T2W imaging within twelve months of randomisationRadiological staging to exclude metastatic disease, prior to starting ADT, with one of the following: PSMA PET-CT, fluciclovine/choline PET-CT, whole-body MRI, bone scan, CT of chest, abdomen and pelvis (imaging method as per local practice/standard of care).WHO performance status 0-2Ability of research subject to give written informed consentExclusion Criteria:N1 or M1 diseasePSA >50ng/ml (or >25ng/ml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed to confirm N0M0 diseasePrevious active treatment for prostate cancerPatients where SBRT is contraindicated: prior pelvic radiotherapy, inflammatory bowel disease, significant lower urinary tract symptoms N.B. where patient has repeated imaging showing bowel in close apposition to target volumes that would make pelvic radiotherapy highly unlikely to be deliverable should be excluded.Contraindications to fiducial marker insertion, where used- including clotting disorders, or patients at high risk when stopping anticoagulation or antiplatelet medicationsBilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult.Patients who have had chemotherapy within 6 weeks of the start of radiotherapy.Life expectancy < 5 years

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05613023). StuddyBuddy aggregates publicly available trial information.