Comparison of Intermittent Androgen Deprivation Therapy With or Without Irradiation Recovery in Prostate Cancer Patients
Status:
Recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
Summary
Metastatic prostate cancer has traditionally been regarded as an incurable dissemination of
disease, and treatment is focused on delaying progression rather than eliminating all tumor
burden. Local therapies, and specifically radiotherapy, have been directed at quality of life
endpoints and not at improving survival. However, advances in imaging and systemic therapy
have identified a population of 'oligometastatic' patients who have a lower burden of
metastatic disease (usually ≤5 lesions), who may present an exception. This condition is
hypothesized to occupy the hinterland between incurable metastatic disease and locoregional
disease, where micrometastatic disease is assumed to exist and yet remain eradicable.
Oligometastases can be detected using standard imaging but the sensitivity of these exams is
very low for patients with a PSA below 10 ng/ml. In France, FCH PET imaging is now routinely
available in a large majority of cancer centres. More recently, PSMA PET imaging has been
developed.
Since most oligometastases are now discovered at a time when conventional imaging is unable
to detect metastases, we must rely on the literature regarding purely biochemically-relapsing
prostate cancer patients. Three strategies have been explored: (i) observation until symptoms
develop, (ii) early intermittent Androgen Deprivation Therapy (IADT) and (iii) continuous
Androgen Deprivation Therapy (ADT). Recent data suggest that, of the three strategies, early
intermittent ADT was superior in term of overall survival to observation in controlling
metastatic prostate cancer, and this effect was similar in the biochemically-relapsing
prostate cancer patient population.
This phase III study will explore the role of salvage pelvic IG-IMRT combined with
intermittent ADT (IADT) in pelvic oligometastatic patients in prolonging the first
failure-free interval between the first and the second intermittent ADT courses.
Phase:
N/A
Details
Lead Sponsor:
Institut Cancerologie de l'Ouest
Collaborators:
Astellas Pharma Inc Direction Générale de l'Offre de Soins