Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients (Oligo-PRESTO)

Unicancer

Status and phase: Enrolling; Phase 3

Conditions: Oligometastatic Hormone Sensitive Prostate Cancer

Treatments: Radiation: Stereotactic Body Radiotherapy (SBRT) + Standard of care; Drug: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT04115007

UC-0160/1716

2017-A03104-49 (Registry Identifier)

Details and patient eligibility

About

INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study.

PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.

Enrollment: 550 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DIAGNOSIS AND INCLUSION CRITERIA:

1. Histologically proven adenocarcinoma of the prostate (any T stage, Gleason score, or prostate specific antigen (PSA) level);

2. Defined as M1 based on the presence of at least one bone metastasis;

3. Diagnostic workup including functional imaging (F or C-Choline-PET/CT or prostate specific membrane antigen (PSMA) PET/CT or whole body MRI) - done prior to the start of hormonal therapy;

4. With up to 5 asymptomatic or paucisymptomatic metastatic sites including at least one bone +/- pulmonary lesion +/- nodal mestastases. Are counted as a "separate" metastatic site :

   • each bone lesion, whatever the location (including pelvic localization), except if two lesions show hyperfixation in the same bone and are located < 1cm from each other they can be counted as one lesion
   • each node or nodal area located outside the true pelvis with a small diameter of 1cm or greater or with univoqual abnormal function imaging (PET Scan hyperfixation or hypersignal in whole body MRI); if multiple nodes are in close vicinity (<1cm distance between them and <4cm in total distance including the nodes, amenable to one SBRT treatment) they can be counted as one lesion
   • and patients with lung metastasis can be included

5. Patients with a previous prostatectomy or radiotherapy to the prostate and/or pelvic lymph nodes are eligible provided they have no active disease within the irradiated areas, based on functional imaging findings;

6. Age ≥18 years;

7. Eastern Cooperative Oncology Group (ECOG) ≤2;

8. Suitable for long term anti androgen therapy;

9. Patient not suitable for docetaxel or abiraterone can be included;

10. Patient that have started long term hormonal therapy are eligible if hormonal therapy has been initiated less than 2 months before randomization;

11. Patients must agree to use adequate contraception methods for the duration of study treatment and for 6 months after completing treatment;

12. Patient must have received the information sheet and signed the consent form;

13. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures;

14. Patient must be affiliated to the social security system.

NON-INCLUSION CRITERIA:

1. Patient with more than 5 metastatic sites;
2. Patient with isolated Rib hyperfixation on functional imaging without a clear correlate on morphological imaging;
3. Patient with metastatic sites other than bone, lymph nodes or lung;
4. Metastases not amenable to radiotherapy treatment with high/curative doses by multidisciplinary meeting [i.e. SBRT as per protocol or curative doses using moderate hypofractionation (55-60Gy/20) or conventional fractionation (≥74 Gy)] (e.g. gross epidural involvement, involvement of three contiguous vertebral bodies, major soft tissue involvement, and previous radiation treatment);
5. Metastases requiring immediate treatment due to significant pain (use of opioid medication), or at risk of fracture or neurological deficit;
6. Prior radiotherapy or focal ablative treatment (cryotherapy, radiofrequency ablation,...) to metastatic lesions;
7. Patients previously treated by Hormonotherapy with castrate testosterone level <50 ng/dL or ≤0.50 ng/mL or 1.73 nmol/L prior use of ADT;
8. Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for ≥5 years;
9. Contra-indication to MRI (needed for spinal SBRT);
10. Persons deprived of their liberty or under protective custody or guardianship;
11. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons;
12. Participation in another therapeutic trial within 30 days prior to randomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

Arm A

Experimental group

Description:

Standard of care + Stereotactic Body Radiotherapy to oligometastases

Treatment:

Radiation: Stereotactic Body Radiotherapy (SBRT) + Standard of care

Arm B

Active Comparator group

Description:

Standard of care

Treatment:

Drug: Standard of care