Phase 2 N=74 Treatment

Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02274779 ↗

Enrolled (actual)

Serious AEs

7.5%

Results posted

Feb 2026

Primary outcome: Primary: Median Relapse-Free Survival Time (Biochemical or Clinical) — 45.3 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ELIGARD (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Institut Cancerologie de l'Ouest
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Relapse-Free Survival Time (Biochemical or Clinical)	45.3	—

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.

Eligibility Criteria

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
Treatment with hormone therapy may be started before inclusion, to a maximum of three months prior to Day 1 of radiotherapy. This hormone will necessarily be preceded by a free interval treatment of at least 6 months since the last injection, by adding the duration of action of this predictable injection (1, 3 or 6 months)
Patient affiliated to a social security scheme
Patient Information and written informed consent form signed

Exclusion Criteria

bone or visceral metastatic relapse associated
para-aortic nodal relapse (the upper limit is tolerated aortic bifurcation)
more than 5 lymph node metastases
Proof of metastases at initial diagnosis
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, ...)
known contraindications to hormone therapy, according to standard recommendations in force
serious Hypertension not controlled by appropriate treatment
Other concomitant cancer or history of cancer (within 5 years prior to study entry), except basal cell or squamous cell carcinomas of the skin.
Patient with a psychological, familial, sociological or geographical potentially hampering compliance with the study protocol and follow-up schedule
Patient already included in another interventional study involving the approval of a CPP during his screening for the study OLIGOPELVIS
Private person of liberty or major trust

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02274779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.