1. The Dedicated Imaging Post-Prostatectomy for Enhanced Radiotherapy outcomes (DIPPER) trial protocol: a multicentre, randomised trial of salvage radiotherapy versus surveillance for low-risk biochemical recurrence after radical prostatectomy.
- Author
-
Roberts MJ, Conduit C, Davis ID, Effeney RM, Williams S, Martin JM, Hofman MS, Hruby G, Eapen R, Gianacas C, Papa N, Lourenço RA, Dhillon HM, Allen R, Fontela A, Kaur B, and Emmett L
- Subjects
- Male, Humans, Prostate pathology, Positron Emission Tomography Computed Tomography methods, Androgen Antagonists therapeutic use, Neoplasm Recurrence, Local pathology, Australia epidemiology, Prostatectomy methods, Salvage Therapy methods, Gallium Radioisotopes therapeutic use, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Clinical Trials, Phase II as Topic, Prostate-Specific Antigen, Prostatic Neoplasms diagnostic imaging, Prostatic Neoplasms radiotherapy, Prostatic Neoplasms surgery
- Abstract
Background: Salvage radiation therapy (SRT) and surveillance for low-risk prostate-specific antigen (PSA) recurrence have competing risks and benefits. The efficacy of early SRT to the prostate bed with or without pelvic lymph nodes compared to surveillance in patients with PSA recurrence after radical prostatectomy and no identifiable recurrent disease evident on prostate specific membrane antigen-positron emission tomography/computer tomography (PSMA-PET/CT) is unknown., Study Design: The Dedicated Imaging Post-Prostatectomy for Enhanced Radiotherapy outcomes (DIPPER) is an open-label, multicentre, randomised Phase II trial., Endpoints: The primary endpoint is 3-year event-free survival, with events comprising one of PSA recurrence (PSA ≥0.2 ng/mL higher than baseline), radiological evidence of metastatic disease, or initiation of systemic or other salvage treatments. Secondary endpoints include patient-reported outcomes, treatment patterns, participant perceptions, and cost-effectiveness., Eligibility Criteria: Eligible participants have PSA recurrence of prostate cancer after radical prostatectomy, defined by serum PSA level of 0.2-0.5 ng/mL, deemed low risk according to modified European Association of Urology biochemical recurrence risk criteria (International Society for Urological Pathology Grade Group ≤2, PSA doubling time >12 months), with no definite/probable recurrent prostate cancer on PSMA-PET/CT., Patients and Methods: A total of 100 participants will be recruited from five Australian centres and randomised 1:1 to SRT or surveillance. Participants will undergo 6-monthly clinical evaluation for up to 36 months. Androgen-deprivation therapy is not permissible. Enrolment commenced May 2023., Trial Registration: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622001478707)., (© 2023 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)
- Published
- 2024
- Full Text
- View/download PDF