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

Primary Purpose

Prostate Cancer

Status

Active

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

ELIGARD

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer,Oligometastasis,Radiotherapy,Hormonotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

ICO Paul Papin
ICO René Gauducheau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hight dose IMRT, ELIGARD

Arm Description

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.

Outcomes

Primary Outcome Measures

biochemical or clinical relapse-free survival at 2 years

The biochemical or clinical relapse is defined by: a PSA level greater than the PSA before treatment, with two successive elevations in the same laboratory and / or an increase in the number of metastatic sites at the evaluation visit

Secondary Outcome Measures

gastrointestinal toxicities after radiation

main toxicities expected are : proctitis, ileitis, diarrhea

Local relapse versus distant relapse

Medical imaging exams will be performed every 6 month for 2 years, and then every years until patient progression

Overall survival

overall survival will be assessed every year during patient life

Full Information

NCT ID

NCT02274779

First Posted

October 21, 2014

Last Updated

July 31, 2023

Sponsor

Institut Cancerologie de l'Ouest

Collaborators

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT02274779

Brief Title

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

Acronym

OLIGOPELVIS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 20, 2014 (Actual)

Primary Completion Date

July 24, 2018 (Actual)

Study Completion Date

July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Cancerologie de l'Ouest

Collaborators

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate Cancer,Oligometastasis,Radiotherapy,Hormonotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hight dose IMRT, ELIGARD

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ELIGARD

Other Intervention Name(s)

Leuproréline

Intervention Description

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 Outcome Measure Information:

Title

biochemical or clinical relapse-free survival at 2 years

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

gastrointestinal toxicities after radiation

Description

main toxicities expected are : proctitis, ileitis, diarrhea

Time Frame

1 month (acute toxicities) and 2 years (late toxicities)

Title

Local relapse versus distant relapse

Description

Medical imaging exams will be performed every 6 month for 2 years, and then every years until patient progression

Time Frame

expected up to 24 month

Title

Overall survival

Description

overall survival will be assessed every year during patient life

Time Frame

every year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

SUPIOT Stéphane, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

ICO Paul Papin

City

Angers

Country

France

Facility Name

ICO René Gauducheau

City

Saint-Herblain

ZIP/Postal Code

44800

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26408012

Citation

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.

Results Reference

derived

PubMed Identifier

25963190

Citation

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.

Results Reference

derived

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

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