DIPPER: This study aims to compare whether radiation therapy delivered directly to the prostate (with or without radiation therapy to close lymph glands) is more effective than active surveillance to control cancer recurrence in people with prostate cancer who have had prior treatment, including the surgeryA multi-centre, randomised phase 2 clinical trial of early salvage radiotherapy versus surveillance on the incidence of biochemical recurrence after radical prostatectomy for men with prostate cancer, incorporating clinical and imaging-based risk stratification.

Summary

Eligible participants will be randomly allocated to one of two cohorts. In Cohort 1, participants will not undergo radiation therapy 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 for their cancer. In Cohort 2, participants will undergo specific radiation therapy to their prostate area, with or without additional radiation therapy of their pelvic lymph nodes as decided by their treating clinician. Before starting radiation therapy, 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 radiation therapy. The radiation therapy is given over about 6 and a half weeks. Participants will need to come in for treatment 5 times a week and will have a total of 32-35 treatments. Each radiation therapy treatment will take approximately 15 minutes each day. Following the radiation therapy, 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.

Conditions

This trial is treating patients with people with prostate cancer who have had prior treatment

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