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ACTIVE NOT RECRUITING
NCT03630666
NA

Comparison of Intermittent Androgen Deprivation Therapy With or Without Irradiation Recovery in Prostate Cancer Patients

Sponsor: Institut Cancerologie de l'Ouest

View on ClinicalTrials.gov

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.

Official title: A Study Comparing Intermittent Androgen Depriving Therapy With Or Without Salvage High-Dose Intensity Modulation Radiotherapy (IG-IMRT)To Oligometastatic Pelvic Lymph Nodes In Biochemically-relapsing Prostate Cancer Patients.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2018-12-04

Completion Date

2026-06

Last Updated

2025-08-17

Healthy Volunteers

No

Interventions

DRUG

IADT

Patient will receive one injection of IADT at randomization

COMBINATION_PRODUCT

IADT + radiotherapy

Patient will receive one injection of IADT at randomization then will receive irradiation 3 months after injection of IADT

Locations (16)

Institut Sainte Catherine

Avignon, France

Institut Bergonie

Bordeaux, France

CHRU de Brest

Brest, France

Clinique Pasteur

Brest, France

Institut de Cancérologie de Bourgogne

Chalon-sur-Saône, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Georges François Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Centre Léon Bérard

Lyon, France

Institut de Cancérologie de Montpellier

Montpellier, France

Centre Azureen de Cancerologie

Mougins, France

Institut de Cancérologie

Nantes, France

Hopital Privé du Confluent

Nantes, France

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, France

ICL Lucien Neuwirth

Saint-Priest-en-Jarez, France

Centre Saint Yves

Vannes, France