Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer

Launched by INSTITUTE OF CANCER RESEARCH, UNITED KINGDOM · Oct 14, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat men with localized prostate cancer using a method called stereotactic body radiotherapy (SBRT). The researchers want to find out whether it's better to give this treatment in five smaller sessions over ten days or in just two larger sessions over eight days. SBRT is a precise type of radiation therapy that targets the prostate with high doses while minimizing exposure to surrounding healthy tissue. The treatment will be delivered using an advanced machine called an MR-linac, which combines MRI imaging with radiation therapy, allowing doctors to adjust the treatment each day to better focus on the cancer.

To participate in this trial, men must be at least 18 years old and have been diagnosed with prostate cancer that requires treatment. They should also have certain health criteria, such as specific cancer grades and manageable prostate sizes. Participants will receive treatment alongside standard care, which includes hormone therapy for at least six months. Throughout the trial, participants will complete questionnaires to help researchers understand their experience and any side effects. This study is important because it could help determine if the shorter treatment option is safe and effective for men with prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Men aged ≥18 years
• • 2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
• • 3. Gleason score 3+4 or 4+3 (Grade groups 2 or 3)
• • 4. MRI stage T3a or less
• • 5. PSA \<25 ng/ml prior to starting ADT (Androgen deprivation therapy)
• • 6. Patients will be concurrently treated with androgen deprivation therapy (ADT) for at least 6 months, as per standard of care. Men who need longer courses of ADT (maximum 12 months) will be considered on a case-by-case basis, and bicalutamide monotherapy is accepted as an alternative to LHRH (luteinizing hormone-releasing hormone) analogues if required.
• • 7. WHO (World Health Organisation) Performance status 0-2
• • 8. Ability of the participant understand and the willingness to sign a written informed consent form.
• • 9. Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
• Exclusion Criteria:
• • 1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
• • 2. International Prostate Symptom Score (IPSS) 13 or higher
• • 3. Post-void residual \>100 mls
• • 4. Prostate volume \>80cc
• • 5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
• • 6. Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
• • 7. Previous pelvic radiotherapy
• • 8. Patients needing 2-3 years of ADT due to disease parameters.
• • 9. Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.