Status:
COMPLETED
Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer
Lead Sponsor:
Institut Cancerologie de l'Ouest
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 oligometast...
Detailed Description
1. Hormonotherapy Hormone therapy is recommended Eligard 45 mg acting for 6 months. It will be ideally administered the day of start of radiation therapy or within 3 months before the first day of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2024
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02274779
Start Date
August 20 2014
End Date
July 22 2024
Last Update
August 17 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
ICO Paul Papin
Angers, France
2
ICO René Gauducheau
Saint-Herblain, France, 44800