NCT02274779CompletedPhase 2
Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer
Multicentric Phase II Trial of Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (OLIGOPELVIS / GETUG P07)
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 74 (actual)
- First submitted
- 21 Oct 2014
- Start date
- 20 Aug 2014
- Primary completion date
- 24 Jul 2018
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Diseases
- Prostate cancer
- NCT number
- NCT02274779
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 74
- From 20 Aug 2014 to the primary completion date, 24 Jul 2018
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- known contraindications to hormone therapy, according to standard recommendations in force
Other illness
- known contraindications to pelvic irradiation (eg, chronic inflammatory bowel disease, ...)
- 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.
Other
- 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
- castration resistance defined by clinical or biochemical progression despite a combined androgen blockade
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICO Paul Papin Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Ico Rene Gauducheau Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.