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Prostate CancerPhase 2OLIGOPELVISNCT02274779

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

A Phase 2 study testing ELIGARD in people with Prostate Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
ELIGARD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
2 sitesFrance
Study dates
20 Aug 2014to 22 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • ICO Paul Papin

    Angers

  • ICO René Gauducheau

    Saint-Herblain, 44800

Other trials in France

About this study

Official title: Multicentric Phase II Trial of Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (OLIGOPELVIS / GETUG P07)

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.

Read the 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 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.

Conditions
Prostate Cancer
Being tested
ELIGARD
Keywords
Prostate Cancer,Oligometastasis,Radiotherapy,Hormonotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELIGARDDrug

    Also called 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.

Study groups in NCT02274779
Study groupRoleWhat they receive
Hight dose IMRT, ELIGARDExperimental* 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.
Receives: Drug: ELIGARD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2014 (estimated)
  2. Study start20 Aug 2014
  3. Primary completion24 Jul 2018
  4. Study completion22 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02274779
Sponsor's protocol ID
ICO-N-2014-02
Acronym
OLIGOPELVIS
Status last verified
Sep 2025
First submitted
21 Oct 2014
Last updated
13 Feb 2026
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 26408012

  • 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.

    PubMed 25963190

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ELIGARD in people with Prostate Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Relapse-Free Survival Time (Biochemical or Clinical) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02274779, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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