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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorInstitute of Cancer Research, United Kingdom

About this trial

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

Qualifiers

Aged ≥ 18 years at randomisation

Histopathological 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 therapy

High risk localised prostate cancer as defined by

Disqualifiers

N1 or M1 disease

PSA >50ng/ml (or >25ng/ml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed to confirm N0M0 disease

Previous active treatment for prostate cancer

Patients 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.

Trial design

Treatments tested in this trial

  • SBRT

Treatment groups

1,128 Participants
are divided into 2 treatment groups

Sponsors and collaborators