Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients

NCT ID: NCT04115007

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-23
• Study Completion Date: 2031-02-28

Brief Summary

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.

Conditions

Oligometastatic Hormone Sensitive Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Standard of care + Stereotactic Body Radiotherapy to oligometastases

Group Type: EXPERIMENTAL

Stereotactic Body Radiotherapy (SBRT) + Standard of care

Intervention Type: RADIATION

Definition of standard of care (prior to randomization):

• Radiotherapy to the prostate in de novo metastatic patients
• Radiotherapy to the pelvic lymph nodes in patients with positive pelvic nodes (given as full dose to the positive lymph node and prophylactic dose to the pelvic nodal basin)
• Long term ADT +/- intermittent treatment
• Additional therapy following tumor board meeting : new generation hormonal therapy (abiraterone, enzalutamide, apalutamide or other approved) or chemotherapy (docetaxel).

SBRT is delivered using the following regimen: 30 Grays (10 Gy x 3 fractions) for axial and appendicular bones and lymph node metastases if present. In case the dose cannot be safely delivered while maintaining a safe dose to the organs at risk, an alternate regimen (35 Gy in 5 fractions of 7 Gy) can be used.

Arm B

Standard of care

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: DRUG

Definition of standard of care (prior to randomization):

• Radiotherapy to the prostate in de novo metastatic patients
• Radiotherapy to the pelvic lymph nodes in patients with positive pelvic nodes (given as full dose to the positive lymph node and prophylactic dose to the pelvic nodal basin)
• Long term ADT +/- intermittent treatment
• Additional therapy following tumor board meeting : new generation hormonal therapy (abiraterone, enzalutamide, apalutamide or other approved) or chemotherapy (docetaxel).

Interventions

Stereotactic Body Radiotherapy (SBRT) + Standard of care

Definition of standard of care (prior to randomization):

• Radiotherapy to the prostate in de novo metastatic patients
• Radiotherapy to the pelvic lymph nodes in patients with positive pelvic nodes (given as full dose to the positive lymph node and prophylactic dose to the pelvic nodal basin)
• Long term ADT +/- intermittent treatment
• Additional therapy following tumor board meeting : new generation hormonal therapy (abiraterone, enzalutamide, apalutamide or other approved) or chemotherapy (docetaxel).

SBRT is delivered using the following regimen: 30 Grays (10 Gy x 3 fractions) for axial and appendicular bones and lymph node metastases if present. In case the dose cannot be safely delivered while maintaining a safe dose to the organs at risk, an alternate regimen (35 Gy in 5 fractions of 7 Gy) can be used.

Intervention Type: RADIATION

Standard of care

Definition of standard of care (prior to randomization):

• Radiotherapy to the prostate in de novo metastatic patients
• Radiotherapy to the pelvic lymph nodes in patients with positive pelvic nodes (given as full dose to the positive lymph node and prophylactic dose to the pelvic nodal basin)
• Long term ADT +/- intermittent treatment
• Additional therapy following tumor board meeting : new generation hormonal therapy (abiraterone, enzalutamide, apalutamide or other approved) or chemotherapy (docetaxel).

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre BLANCHARD, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Institut Sainte Catherine

Avignon, , France

Institut Bergonié

Bordeaux, , France

Centre d'oncologie - Clinique Pasteur

Brest, , France

CHRU de Brest

Brest, , France

Centre François Baclesse

Caen, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre Amethyst de Creil

Creil, , France

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Institut de cancérologie de Seine et Marne - Clinique de Jossiny

Jossigny, , France

Centre Oscar Lambret

Lille, , France

Groupe Hospitalier Bretagne Sud

Lorient, , France

Centre Leon Berard

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

Centre Azureen de Cancerologie

Mougins, , France

Hôpital Privé du Confluent

Nantes, , France

ICO René Gauducheau

Nantes, , France

Centre Antoine Lacassagne

Nice, , France

Institut Curie

Paris, , France

CHU Lyon Sud

Pierre-Bénite, , France

CH Annecy

Pringy, , France

Institut du Cancer Courlancy

Reims, , France

Centre Eugene Marquis

Rennes, , France

CHU de Rouen - Charles Nicole

Rouen, , France

Centre Henri Becquerel

Rouen, , France

Institut de cancérologie et d'hématologie universitaire de Saint Etienne

Saint-Etienne, , France

CHP Saint Grégoire

Saint-Grégoire, , France

HIA Begin

Saint-Mandé, , France

Institut de Cancerologie Paris Nord

Sarcelles, , France

Institut de cancérologie Strasbourg Europe (ICANS )

Strasbourg, , France

IUCT- Oncopole -Institut Claudius Regaud

Toulouse, , France

Clinique PASTEUR

Toulouse, , France

Centre de radiothérapie Marie Curie de Valence

Valence, , France

Centre Amethyst - Oncologie 78

Versailles, , France

Gustave Roussy Cancer Campus Grand Paris

Villejuif, , France

CHU Martinique

Fort-de-France, , Martinique

Countries

France; Martinique

References

Petrelli F, Ghidini A, Ghidini M, Bukovec R, Trevisan F, Turati L, Indini A, Seghezzi S, Lonati V, Moleri G, Tomasello G, Zaniboni A. Better survival of patients with oligo- compared with polymetastatic cancers: a systematic review and meta-analysis of 173 studies. F1000Res. 2021 May 27;10:423. doi: 10.12688/f1000research.52546.4. eCollection 2021.

Reference Type: DERIVED

PMID: 35602670 (View on PubMed)

Other Identifiers

2017-A03104-49

Identifier Type: REGISTRY

Identifier Source: secondary_id

UC-0160/1716

Identifier Type: -

Identifier Source: org_study_id