Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment eligard
Phase phase 2
Sponsor Institut Cancerologie de l'Ouest
Collaborator Astellas Pharma Inc
Start date September 2014
End date July 2015
Trial size 70 participants
Trial identifier NCT02274779, ICO-N-2014-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
PTV1 PTV5 to 66 Gy in 30 fractions of 2.2 Gy PTV Pelvis: 54 Gy in 30 fractions of 1.8 Gy PTV Loge 60 Gy in 30 fractions of 2 Gy 6 Gy A complement of 3 in two additional fractions Gy may be delivered across the lodge PTV. PTV Relapse Lodge: In addition to treating the PTV Lodge, additional radiation of 6 Gy in 3 fractions of 2 Gy may be made to bring the total dose of 72 Gy in 36 fractions of 2 Gy.
eligard Leuproréline
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 radiotherapy. Nevertheless, free prescription is left to investigators. When using other hormonal strategies (anti-androgen agonists, LHRH antagonists or LHRH), an administration for six months will be critical.

Primary Outcomes

Measure
biochemical or clinical relapse-free survival at 2 years
time frame: 2 years

Secondary Outcomes

Measure
gastrointestinal toxicities after radiation
time frame: 1 month (acute toxicities) and 2 years (late toxicities)
Local relapse versus distant relapse
time frame: expected up to 24 month
Overall survival
time frame: every year
Quality of life
time frame: 2 years

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: 1. Histologically proven adenocarcinoma of the prostate 2. Patients aged 18 years or more 3. PS 0-1 4. Previous radical treatment to the prostate (radiotherapy or surgery) 5. PSA increase of at least 3 assays in the same laboratory over the last 12 months. 6. 1-5 pelvic lymph node metastases detected with 18FCH-PET. A relapse in the dressing prostatectomy is associated possible. 7. Upper limit of lymph node metastases: aortic bifurcation 8. Respect dosimetric constraints to organs at risk 9. 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) 10. Patient affiliated to a social security scheme 11. Patient Information and written informed consent form signed Exclusion Criteria: 1. bone or visceral metastatic relapse associated 2. para-aortic nodal relapse (the upper limit is tolerated aortic bifurcation) 3. more than 5 lymph node metastases 4. Proof of metastases at initial diagnosis 5. Evidence of distant metastases in the pelvic lymph nodes or outside the prostate bed 6. 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 7. castration resistance defined by clinical or biochemical progression despite a combined androgen blockade 8. known contraindications to pelvic irradiation (eg, chronic inflammatory bowel disease, ...) 9. known contraindications to hormone therapy, according to standard recommendations in force 10. serious Hypertension not controlled by appropriate treatment 11. Other concomitant cancer or history of cancer (within 5 years prior to study entry), except basal cell or squamous cell carcinomas of the skin. 12. Patient with a psychological, familial, sociological or geographical potentially hampering compliance with the study protocol and follow-up schedule 13. Patient already included in another interventional study involving the approval of a CPP during his screening for the study OLIGOPELVIS 14. Private person of liberty or major trust

Additional Information

Official title Multicentric Phase II Trial of Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (OLIGOPELVIS / GETUG P07)
Principal investigator SUPIOT Stéphane, MD
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 radiotherapy. Nevertheless, free prescription is left to investigators. When using other hormonal strategies (anti-androgen agonists, LHRH antagonists or LHRH), an administration for six months will be critical. 2. Radiotherapy Conformational Radiotherapy techniques in Intensity-Modulated (IMRT) 2.1) Doses prescribed - PTV1 PTV5 to 66 Gy in 30 fractions of 2.2 Gy - PTV Pelvis: 54 Gy in 30 fractions of 1.8 Gy - PTV Loge 60 Gy in 30 fractions of 2 Gy 6 Gy A complement of 3 in two additional fractions Gy may be delivered across the lodge PTV. - PTV Relapse Lodge: In addition to treating the PTV Lodge, additional radiation of 6 Gy in 3 fractions of 2 Gy may be made to bring the total dose of 72 Gy in 36 fractions of 2 Gy. 2.2) Treatment Radiation Guided by a picture (IGRT) will be performed daily. This daily recalibration will be based at least on bone structures. It will be possible to readjust the nodal structures.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Institut Cancerologie de l'Ouest.