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.
Screening procedures will be performed up to three months before starting IADT. After obtaining informed consent, patients will be randomly allocated to one of two groups: Experimental group: IADT + IG-IMRT Control group: IADT In both study arms, the first injection of IADT will be administered in hospital on the day of randomization. The overall duration of IADT will be six months. In the experimental group, patients will receive radiotherapy three months after the first injection of IADT. The overall duration of radiotherapy will be three months. The overall duration of IADT will be six months. It will be administered three months, +/- 15 days prior to the first day of radiotherapy. At the completion of the six-month treatment period, a non-treatment interval will start if : there is no evidence of clinical disease progression and the PSA level is ≤ 4.00 ng/ml If the PSA subsequently rises above 0.20 ng/ml and is confirmed by a second measurement at least three weeks later, PET/CT imaging will be repeated every 6 months until a clinical failure is detected or until the PSA rises above 4.00 ng/ml.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
Patient will receive one injection of IADT at randomization
Patient will receive one injection of IADT at randomization then will receive irradiation 3 months after injection of IADT
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
...and 6 more locations
progression-free survival
PSA or CT scan
Time frame: 90 months
overall survival
death
Time frame: 90 months
time to castration-resistance
serum testosterone mesure
Time frame: 90 months
toxicity to IADT and radiation
evaluation with NCI-CTC AE v4.03
Time frame: 90 months
Quality of life during long-term treatment
Quality of life will be assessed every 3 months using the EORTC QLQ-C30 and the prostate cancer-specific module QLQ-PR25. These validated questionnaires evaluate physical, emotional, and social functioning, as well as symptoms related to prostate cancer and its treatment.
Time frame: Up to 90 months after start of treatment
site of tumor progression
FCH or PSMA PET at biochemical relapse
Time frame: 90 months
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