NCT02274779

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	ELIGARD	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.

Timeline

• Start date: 2014-08-20
• Primary completion: 2018-07-24
• Completion: 2024-07-22
• First posted: 2014-10-24
• Last updated: 2026-02-13
• Results posted: 2026-02-13

Locations

2 sites across 1 country: France