None listed
Conditions
Brief 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.
Interventions
Salvage radiotherapy (SRT)
Participants allocated to SRT group will receive a course of radiotherapy to the area where the prostate gland used to be (the prostate bed) and potentially to the lymph glands related to the prostate in the pelvis. Salvage radiotherapy should commence within eight weeks of enrolment. Radiotherapy plan will occur according to Participants treating radiation oncologist. Before starting the radiotherapy, participant will have a CT scan of the pelvic area, which is used t
Salvage radiotherapy (SRT) Participants allocated to SRT group will receive a course of radiotherapy to the area where the prostate gland used to be (the prostate bed) and potentially to the lymph glands related to the prostate in the pelvis. Salvage radiotherapy should commence within eight weeks of enrolment. Radiotherapy plan will occur according to Participants treating radiation oncologist. Before starting the radiotherapy, participant will have a CT scan of the pelvic area, which is used to plan the radiotherapy. Pelvic lymph node radiotherapy (PLNRT) treatment is optional, according to clinician discretion. 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 including prostate-specific antigen (PSA) blood testing per usual standard of care. These assessments are scheduled every 6 months post-randomisation for a minimum of 3 years post-randomisation or until study end. Participants will also be asked to complete a series of questionnaires to provide information on their health and wellbeing at baseline, 6 months post-randomisation, then annually for a minimum of 3 years post-randomisation or until study end.
Sponsors
The Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Previous prostate cancer diagnosis treated with radical prostatectomy 2. Post-prostatectomy biochemical recurrence (Prostate-specific antigen (PSA) 0.2 - 0.5 nanograms per milliliter) with documented 2 consecutive PSA rises taken at least 14 days apart 3. Low risk features (Gleason score less than equal to 3 plus 4 / ISUP grade group less than equal to 2 and PSA doubling time greater than 12 months) 4. Willing to complete study requirements (treatments, questionnaires etc.) 5. ECOG performance status 0 or 1 6. Estimated life expectancy greater than 7yrs 7. Prior PSMA PET/CT for investigation of early biochemical recurrence 8. Prior pelvic radiation therapy that would impact delivery of the protocol radiotherapy
Exclusion criteria
1. Contraindications to radiotherapy (e.g., active inflammatory bowel disease) 2. Prior or current androgen deprivation therapy (ADT) or other systemic therapy for prostate cancer 3. Bilateral orchidectomy 4. Positive regional nodal disease (N1 positive) at radical prostatectomy 5. Evidence of metastatic disease on any imaging modality 6. History of another malignancy within 5 years prior to randomisation except for those listed 7. Concurrent illness that might jeopardise the ability to undergo study procedures 8. Participation in other clinical trials of investigational agents for treatment of prostate cancer or other diseases
Outcome results
None listed