Evaluating the efficacy of radiation therapy compared to surveillance in men with prostate cancer that has returned after surgery and negative Prostate specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) scan. - Trial ANZCTR12622001478707

Timeline & Enrollment

Primary Outcome

Event free survival

Summary

This study aims to compare radiation therapy delivered directly to the prostate with or without radiotherapy to close lymph glands, to active surveillance in terms of cancer control, in a carefully selected group of men with prostate cancer. Who is it for? You may be eligible for this study if you are an adult male aged 18 or older, who has previously been treated for prostate cancer, including removal of all or part of your prostate. In particular, people who still have active prostate cancer that has low risk features and negative Prostate specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) imaging will be eligible. Study details Participants who choose to enroll in this study will be randomly allocated by chance (similar to flipping a coin) to one of the two study groups. Participants who are allocated to the first group will not undergo radiotherapy and will be seen in clinic at regular intervals by their doctor for routine check-ups and blood tests. The PSA blood test will be done every 6 months to allow surveillance of their cancer. Participants who are allocated to the second group will undergo specific radiotherapy to their prostate area with or without radiotherapy of their pelvic lymph nodes as decided by the treating clinician. Before starting the radiotherapy, participants will have a CT scan of the area where the prostate gland used to be (the prostate bed) and potentially the lymph glands related to the prostate in the pelvis to plan the radiotherapy. The radiotherapy is given over about 6 and half weeks. Participants will need to come in for treatment 5 times a week and will have a total of 32-35 treatments. Each radiotherapy treatment will take approximately 15 minutes each day. Following the radiotherapy, review appointments and investigations will be carried out every 6 months including PSA blood testing. All participants will be asked to complete a series of questionnaires to provide information on their health and wellbeing for up to 3 years after enrolment into the study. It is anticipated that completing these questionnaires will take about 20 minutes at each timepoint. It is hoped this research will determine whether additional radiotherapy directly to the prostate area after removal of the prostate is effective in controlling cancer recurrence in these low-risk patients. If the radiotherapy treatment is found to be better at controlling cancer recurrence for prostate cancer patients compared to the standard care surveillance, it may be introduced as a standard of care for all prostate cancer patients.

ICD-10 Classifications