Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Pros… (NCT02274779) | Clinical Trial Compass
CompletedPhase 2
Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer
France74 participantsStarted 2014-08-20
Plain-language summary
There is an increasing number of reports describing the existence of a proportion of prostate cancer patients who present with a reduced number of metastases (\<5 lesions) at relapse. This oligometastatic status has also been recognized in other tumor types such as melanoma, soft tissue sarcoma, liver, lung, and breast cancer, and has influenced the management of these malignancies in that a more radical treatment such as surgical resection has been employed. Positron Emission Tomography-Computed Tomography (PET-CT) studies with tracers such as choline or acetate are reliable tools to help with the diagnosis of oligometastatic disease after biochemical treatment failure in prostate cancer. An aggressive treatment combining androgen depriving therapy (ADT) and and high-dose irradiation to the oligometastatic lesions, as detected by PET-CT, may be proposed for these oligometastatic patients. Such a treatment strategy may hypothetically succeed to prolong the failure-free interval between two consecutive ADT courses, or even cure selected patients with limited metastatic burden. In this study the investigators plan to assess biochemical or clinical relapse-free survival at 2 years of prostate cancer with 1-5 oligometastases treated concomitantly with high-dose conformal Radiation Therapy and LH-RH agonists.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Histologically proven adenocarcinoma of the prostate
✓. Patients aged 18 years or more
✓. PS 0-1
✓. Previous radical treatment to the prostate (radiotherapy or surgery)
✓. PSA increase of at least 3 assays in the same laboratory over the last 12 months.
✓. 1-5 pelvic lymph node metastases detected with 18FCH-PET. A relapse in the dressing prostatectomy is associated possible.
✓. Upper limit of lymph node metastases: aortic bifurcation
✓. Respect dosimetric constraints to organs at risk
Exclusion criteria
✕. bone or visceral metastatic relapse associated
✕. para-aortic nodal relapse (the upper limit is tolerated aortic bifurcation)
✕
What they're measuring
1
Median Relapse-Free Survival Time (Biochemical or Clinical)
✕. Evidence of distant metastases in the pelvic lymph nodes or outside the prostate bed
✕. prior pelvic lymph nodes Irradiation. Irradiation of the bed of the prostate is not an exclusion criterion, but the junction between prior irradiation bed prostatectomy and radiation field pelvic lymph nodes should be examined carefully
✕. castration resistance defined by clinical or biochemical progression despite a combined androgen blockade
✕. known contraindications to pelvic irradiation (eg, chronic inflammatory bowel disease, ...)