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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT02274779
• Date of registration: 21/10/2014
• Prospective Registration: No
• Primary sponsor: Institut Cancerologie de l'Ouest
• Public title: Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer OLIGOPELVIS
• Scientific title: Multicentric Phase II Trial of Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (OLIGOPELVIS / GETUG P07)
• Date of first enrolment: August 20, 2014
• Target sample size: 70
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02274779
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: SUPIOT Stéphane, MD
• Affiliation: Institut de Cancérologie de l'Ouest (ICO) - Nantes, France

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: ELIGARD

Primary Outcome(s)

biochemical or clinical relapse-free survival at 2 years [Time Frame: 2 years]

Secondary Outcome(s)

Local relapse versus distant relapse [Time Frame: expected up to 24 month]

gastrointestinal toxicities after radiation [Time Frame: 1 month (acute toxicities) and 2 years (late toxicities)]

Overall survival [Time Frame: every year]

Secondary ID(s)

ICO-N-2014-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Astellas Pharma Inc