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

February 15, 2023 updated by: UNICANCER

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Avignon, France, 80005
        • Recruiting
        • Institut Sainte Catherine
        • Contact:
      • Bordeaux, France, 33076
      • Brest, France, 29200
      • Brest, France, 29200
      • Caen, France, 14000
        • Recruiting
        • Centre François Baclesse
        • Contact:
          • Emmanuel MEYER, MD
          • Phone Number: +33 2 31 45 40 34
          • Email: e.meyer@live.fr
      • Clermont-Ferrand, France, 63000
      • Creil, France, 60100
      • Créteil, France, 94000
      • Jossigny, France, 77650
        • Not yet recruiting
        • Institut de cancérologie de Seine et Marne - Clinique de Jossiny
        • Contact:
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
      • Lorient, France, 56000
        • Recruiting
        • Groupe Hospitalier Bretagne Sud
        • Contact:
          • Guillaume BERA, MD
          • Phone Number: +33 2 97 06 74 45
          • Email: g.bera@ghbs.bzh
      • Lyon, France, 69008
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
      • Mougins, France, 06250
        • Recruiting
        • Centre Azuréen de Cancérologie
        • Contact:
      • Nantes, France, 44277
      • Nantes, France, 44805
      • Nice, France, 06189
      • Paris, France, 75005
        • Recruiting
        • Institut Curie
        • Contact:
      • Pierre-Bénite, France, 69495
      • Pringy, France, 74374
      • Reims, France, 51100
        • Recruiting
        • Institut du Cancer Courlancy
        • Contact:
      • Rennes, France, 35042
      • Rouen, France, 76038
      • Rouen, France, 76031
      • Saint Gregoire, France, 35760
      • Saint-Mandé, France, 94160
      • Saint-Étienne, France, 42055
        • Recruiting
        • Institut de cancérologie et d'hématologie universitaire de Saint Etienne
        • Contact:
      • Sarcelles, France, 95200
        • Recruiting
        • Institut de Cancérologie Paris Nord
        • Contact:
      • Strasbourg, France, 67065
        • Recruiting
        • Institut de cancérologie Strasbourg Europe (ICANS )
        • Contact:
      • Toulouse, France, 31076
        • Recruiting
        • Clinique Pasteur
      • Toulouse, France, 31059
      • Valence, France, 26000
        • Recruiting
        • Centre de radiothérapie Marie Curie de Valence
        • Contact:
      • Versailles, France, 78000
        • Not yet recruiting
        • Centre Amethyst - Oncologie 78
        • Contact:
      • Villejuif, France, 94805
  • Martinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 or lung 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 or 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 metastatic sites other than bone, lymph nodes or lung;
  3. 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);
  4. Metastases requiring immediate treatment due to significant pain (use of opioid medication), or at risk of fracture or neurological deficit;
  5. Prior radiotherapy or focal ablative treatment (cryotherapy, radiofrequency ablation,…) to metastatic lesions;
  6. Castrate testosterone level <50 ng/dL or ≤0.50 ng/mL or 1.73 nmol/L prior use of ADT;
  7. Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for ≥5 years;
  8. Contra-indication to MRI (needed for spinal SBRT);
  9. Persons deprived of their liberty or under protective custody or guardianship;
  10. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons;
  11. Participation in another therapeutic trial within 30 days prior to randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Standard of care + Stereotactic Body Radiotherapy to oligometastases
Radiation: 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.
Active Comparator: Arm B
Standard of care
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Castration-resistant prostate cancer free survival
Time Frame: From randomization to castration resistance or death from any cause, up to 1 year
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).
From randomization to castration resistance or death from any cause, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From randomization to death from any cause, up to 5 years
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
From randomization to death from any cause, up to 5 years
Prostate cancer specific survival
Time Frame: From randomization to death from prostate cancer, up to 5 years
To evaluate, compared to standard of care, whether SRBT improves survival of patients until death from prostate cancer
From randomization to death from prostate cancer, up to 5 years
Time to castration resistance
Time Frame: Time from randomization to castration resistance, up to 5 years
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
Time from randomization to castration resistance, up to 5 years
Time to next symptomatic skeletal event
Time Frame: Time from randomization to the first symptomatic skeletal event, up to 5 years
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
Time from randomization to the first symptomatic skeletal event, up to 5 years
Time to next symptomatic skeletal event at the treated metastatic bone sites
Time Frame: Time from randomization to the first symptomatic skeletal event, 5 years
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
Time from randomization to the first symptomatic skeletal event, 5 years
Time to use of intermittent hormonal therapy
Time Frame: Time from randomization to the use of intermittent androgen deprivation therapy, up to 5 years
The length of time patients receive continuous androgen deprivation therapy before the switch to the intermittent androgen deprivation therapy
Time from randomization to the use of intermittent androgen deprivation therapy, up to 5 years
Duration of intermittent hormonal therapy
Time Frame: From the end of continuous therapy to the end of intermittent therapy, up to 5 years
The length of time patients receive intermittent androgen deprivation therapy
From the end of continuous therapy to the end of intermittent therapy, up to 5 years
Time to secondary treatments (local or systemic)
Time Frame: From randomization to initiation of secondary treatment, up to 5 years
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)
From randomization to initiation of secondary treatment, up to 5 years
Acute and late toxicity of stereotactic radiotherapy of oligometastases: Adverse events
Time Frame: Throughout study completion, up to 5 years
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.
Throughout study completion, up to 5 years
Severity of pain during treatment
Time Frame: 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

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]).
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
The 3-level version of EQ-5D (EQ-5D-3L) questionnaire
Time Frame: 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)

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.
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)
Expanded Prostate Cancer Index Composite (EPIC) short form
Time Frame: 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)
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.
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)
Cost-effectiveness analysis of the proposed therapeutic strategy
Time Frame: At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, castration resistance (up to 5 years)
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
At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, castration resistance (up to 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Principal Investigator: Pierre BLANCHARD, MD, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2020

Primary Completion (Anticipated)

June 23, 2025

Study Completion (Anticipated)

June 23, 2028

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 3, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-0160/1716
  • 2017-A03104-49 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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