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Oligometastatic Hormone Sensitive Prostate CancerPhase 3Oligo-PRESTONCT04115007

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

A Phase 3 study of Oligometastatic Hormone Sensitive Prostate Cancer, run by UNICANCER at 35 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
35 sitesin 2 countries
Study dates
23 Jun 2020to 28 Feb 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

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
  1. 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;
  2. Age ≥18 years;
  3. Eastern Cooperative Oncology Group (ECOG) ≤2;
  4. Suitable for long term anti androgen therapy;
  5. Patient not suitable for docetaxel or abiraterone can be included;
  6. Patient that have started long term hormonal therapy are eligible if hormonal therapy has been initiated less than 2 months before randomization;
  7. Patients must agree to use adequate contraception methods for the duration of study treatment and for 6 months after completing treatment;
  8. Patient must have received the information sheet and signed the consent form;
  9. 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;
  10. 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 locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

France34 sites

  • Institut Sainte Catherine

    Avignon, 80005

  • Institut Bergonié

    Bordeaux, 33076

  • Centre d'oncologie - Clinique Pasteur

    Brest, 29200

  • CHRU de Brest

    Brest, 29200

  • Centre François Baclesse

    Caen, 14000

  • Centre Jean Perrin

    Clermont-Ferrand, 63000

  • Centre Amethyst de Creil

    Creil, 60100

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000

  • Institut de cancérologie de Seine et Marne - Clinique de Jossiny

    Jossigny, 77650

  • Centre Oscar Lambret

    Lille, 59020

  • Groupe Hospitalier Bretagne Sud

    Lorient, 56000

  • Centre Leon Berard

    Lyon, 69008

  • Institut Paoli Calmettes

    Marseille, 13009

  • Centre Azureen de Cancerologie

    Mougins, 06250

  • Hôpital Privé du Confluent

    Nantes, 44277

  • ICO René Gauducheau

    Nantes, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie

    Paris, 75005

  • CHU Lyon Sud

    Pierre-Bénite, 69495

  • CH Annecy

    Pringy, 74374

  • Institut du Cancer Courlancy

    Reims, 51100

  • Centre Eugene Marquis

    Rennes, 35042

  • CHU de Rouen - Charles Nicole

    Rouen, 76031

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut de cancérologie et d'hématologie universitaire de Saint Etienne

    Saint-Etienne, 42055

  • CHP Saint Grégoire

    Saint-Grégoire, 35760

  • HIA Begin

    Saint-Mandé, 94160

  • Institut de Cancerologie Paris Nord

    Sarcelles, 95200

  • Institut de cancérologie Strasbourg Europe (ICANS )

    Strasbourg, 67065

  • IUCT- Oncopole -Institut Claudius Regaud

    Toulouse, 31059

  • Clinique PASTEUR

    Toulouse, 31076

  • Centre de radiothérapie Marie Curie de Valence

    Valence, 26000

  • Centre Amethyst - Oncologie 78

    Versailles, 78000

  • Gustave Roussy Cancer Campus Grand Paris

    Villejuif, 94805

Other trials in France

Martinique1 site

  • CHU Martinique

    Fort-de-France, 97261

Other trials in Martinique

About this study

Official title: Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients - a GETUG-AFU Phase III Randomized Controlled Trial

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.

Being tested
Stereotactic Body Radiotherapy (SBRT) + Standard of care, Standard of care

What participants receive

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

  • Stereotactic Body Radiotherapy (SBRT) + Standard of careRadiation

    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.

  • Standard of careDrug

    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).
Study groups in NCT04115007
Study groupRoleWhat they receive
Arm AExperimentalStandard of care + Stereotactic Body Radiotherapy to oligometastases
Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) + Standard of care
Arm BActive comparatorStandard of care
Receives: Drug: Standard of care

What is being measured

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

  1. Castration-resistant prostate cancer free survival

    Castration-resistant prostate cancer free survival, defined as the time from randomization to castration resistance or death from any cause. Castration resistance is defined as either biochemical progression or radiological progression, with serum testosterone being at a castrated level (<50 ng/dL or <1.7 nmol/L).

    Measured: From randomization to castration resistance or death from any cause, up to 1 year

Secondary outcomes (13)

  1. Overall survival

    The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care

    Measured: From randomization to death from any cause, up to 5 years

  2. Prostate cancer specific survival

    To evaluate, compared to standard of care, whether SRBT improves survival of patients until death from prostate cancer

    Measured: From randomization to death from prostate cancer, up to 5 years

  3. Time to castration resistance

    The length of time patients leave without resistance to castration treatment, where deaths occurring with no castration resistance (i.e. unrelated to prostate cancer) are censored

    Measured: Time from randomization to castration resistance, up to 5 years

  4. Time to next symptomatic skeletal event

    The length of time until manifestation of the first symptomatic skeletal event among the following: symptomatic bone fracture, surgery to bone or use of palliative radiotherapy to bone

    Measured: Time from randomization to the first symptomatic skeletal event, up to 5 years

  5. Time to next symptomatic skeletal event at the treated metastatic bone sites

    The length of time until manifestation of the first symptomatic skeletal event, at a site irradiated during the study for patients in the experimental arm, among the following: symptomatic bone fracture, the use of bone surgery, or palliative bone radiotherapy and spinal cord compression

    Measured: Time from randomization to the first symptomatic skeletal event, 5 years

  6. Time to use of intermittent hormonal therapy

    The length of time patients receive continuous androgen deprivation therapy before the switch to the intermittent androgen deprivation therapy

    Measured: Time from randomization to the use of intermittent androgen deprivation therapy, up to 5 years

  7. Duration of intermittent hormonal therapy

    The length of time patients receive intermittent androgen deprivation therapy

    Measured: From the end of continuous therapy to the end of intermittent therapy, up to 5 years

  8. Time to secondary treatments (local or systemic)

    The interval between the randomization and the initiation of the first treatment after disease progression: systemic chemotherapy, second line hormonal therapy, bone directed treatment (bisphosphonate or denosumab), or the use an antalgic palliative bone treatment (interventional radiology or radiotherapy)

    Measured: From randomization to initiation of secondary treatment, up to 5 years

  9. Acute and late toxicity of stereotactic radiotherapy of oligometastases: Adverse events

    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale will assess the severity of sensory neuropathic disorders, this derivative into 5 grades determined by the investigator.

    Measured: Throughout study completion, up to 5 years

  10. Severity of pain during treatment

    The Brief Pain Inventory (BPI) questionnaire rapidly assesses the severity of pain and its impact on functioning. This self-report questionnaire includes:

    • A body schema
    • The maximum pain, lowest pain, usual pain within the last 15 days (Numerical Numeric rating scales (NRS) 0 to 10
    • Description of current analgesic treatment
    • An assessment of relief by a percentage scale (0-100%), Assessment of the impact of pain on: mood, relationships with others, walking, sleep, work, happiness the joy - of living, recreation, activities in general (digital scales, rating from 0 [normal] to 10 [no activity]).

    Measured: At baseline before radiotherapy, week 6, and at every follow-up (every three months for the first three years then every 6 months for the last two years after randomization), up to 5 years

  11. The 3-level version of EQ-5D (EQ-5D-3L) questionnaire

    This self-reported questionnaire that assesses the health-related quality of life of cancer patients in clinical trials consists of a descriptive system and a visual analogue scale (VAS).

    The EQ-5D-3L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension has 3 levels (1 = "no problems", 2 = "some problems", and 3 = "extreme problems"). This questionnaire provide a 5-digit score which generate a health state profile. The VAS records the patient's self-rated health on a vertical visual analogue scale where the score range from 0 (Best imaginable health state) to 100 (Worst imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement.

    Measured: At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and at castration resistance (up to 5 years)

  12. Expanded Prostate Cancer Index Composite (EPIC) short form

    This self-reported questionnaire, designed to evaluate patient function and bother after prostate cancer treatment, contains 26 item divided in 5 domains (Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health-related quality of life.

    Measured: At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and at castration resistance (up to 5 years)

  13. Cost-effectiveness analysis of the proposed therapeutic strategy

    To evaluate the economic cost of the SBRT treatment as compared to the treatment without radiotherapy in terms of cost assessments, incremental cost-effectiveness ratio and quality of life adjusted life years

    Measured: At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, castration resistance (up to 5 years)

Timeline

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

  1. First posted3 Oct 2019
  2. Study start23 Jun 2020
  3. Primary completion23 Jun 2026 (estimated)
  4. Study completion28 Feb 2031 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04115007
Sponsor's protocol ID
UC-0160/1716
Other IDs
2017-A03104-49
Acronym
Oligo-PRESTO
Status last verified
Jun 2025
First submitted
2 Oct 2019
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Publications

  • 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.

    PubMed 35602670

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Oligometastatic Hormone Sensitive Prostate Cancer, run by UNICANCER at 35 sites in 2 countries.

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

Who may be eligible to take part?

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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France, Martinique. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Castration-resistant prostate cancer free survival (time frame: From randomization to castration resistance or death from any cause, up to 1 year). 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 NCT04115007, which also lists 1 linked publication.

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 26 Jun 2025.

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