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

NCT02274779 | Completed Phase 2 Results DMC

• 1 other identifier: ICO-N-2014-02
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer,Oligometastasis,Radiotherapy,Hormonotherapy

Outcome Measures

Primary Outcomes (1)

• Median Relapse-Free Survival Time (Biochemical or Clinical)

  This outcome represents the time from treatment initiation to the occurrence of biochemical or clinical relapse. Relapse is defined as: a PSA level greater than the PSA before treatment, confirmed by two consecutive increases in the same laboratory, and/or an increase in the number of metastatic sites at the evaluation visit. The reported value is the median time to relapse, in months.

  2 years

Study Arms (1)

Hight dose IMRT, ELIGARD

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.

Drug: ELIGARD

Interventions

ELIGARD DRUG

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.

Also known as: Leuproréline

Hight dose IMRT, ELIGARD

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• Patient affiliated to a social security scheme
• Patient Information and written informed consent form signed

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• Astellas Pharma Inc: collaborator

Study Sites (2)

ICO Paul Papin

Angers, France

Location

ICO René Gauducheau

Saint-Herblain, 44800, France

Location

Related Publications (2)

• Supiot S, Rio E, Pacteau V, Mauboussin MH, Campion L, Pein F. OLIGOPELVIS - GETUG P07: a multicentre phase II trial of combined salvage radiotherapy and hormone therapy in oligometastatic pelvic node relapses of prostate cancer. BMC Cancer. 2015 Sep 25;15:646. doi: 10.1186/s12885-015-1579-0.

  PMID: 26408012 DERIVED

• Ploussard G, Almeras C, Briganti A, Giannarini G, Hennequin C, Ost P, Renard-Penna R, Salin A, Lebret T, Villers A, Soulie M, de la Taille A, Flamand V. Management of Node Only Recurrence after Primary Local Treatment for Prostate Cancer: A Systematic Review of the Literature. J Urol. 2015 Oct;194(4):983-8. doi: 10.1016/j.juro.2015.04.103. Epub 2015 May 9.

  PMID: 25963190 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

luprolide acetate gel depot

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Pr Stéphane SUPIOT
• Organization: Institut de Cancérologie de l'Ouest

stephane.supiot@ico.unicancer.fr

2 40 67 99 00

Study Officials

• SUPIOT Stéphane, MD

  Institut de Cancérologie de l'Ouest (ICO) - Nantes, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 24, 2014
• Study Start: August 20, 2014
• Primary Completion: July 24, 2018
• Study Completion: July 22, 2024
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)