Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy (GETUG-AFU22)

December 13, 2024 updated by: UNICANCER

A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy

The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events in the treatment of detectable PSA after radical prostatectomy.

122 patients should be included over a period of 2 years. Patients will be treated according to the following scheme:

  • Arm A (61 patients) : Pelvic Radiotherapy: 46 Gy and prostate only boost up to 66 Gy
  • Arm B (61 patients) : Arm A + hormonal therapy by degarelix during 6 months

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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

Study Locations

  • France
      • Angers, France, 49933
        • Institut de Cancérologie de l'Ouest -Site Paul Papin
      • Avignon, France, 84918
        • Institut Sainte Catherine
      • Besançon, France, 25030
        • Chu Jean Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Brest, France, 29200
        • Centre d'oncologie - Clinique Pasteur
      • Caen, France, 14076
        • Centre François Baclesse
      • Chambéry, France, 73011
        • Centre Hospitalier de Chambery
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Dijon, France, 21000
        • Centre d'Oncologie et de Radiothérapie du Parc
      • Hyeres, France, 83400
        • Clinique Sainte-Marguerite
      • La Roche-sur-Yon, France, 85925
        • CHD Vendee
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Marseille, France, 13009
        • Clinique Clairval
      • Marseille, France, 13385
        • CHU La Timone - Hôpital Nord
      • Montauban, France, 82017
        • Groupe Oncorad Garonne Clinique Du Pont de Chaume
      • Montfermeil, France, 93370
        • Ghi Le Raincy / Montfermeil
      • Mougins, France, 06250
        • Centre Azuréen de Cancérologie
      • Mulhouse, France, 68070
        • Centre Hospitalier Emile Muller
      • Nancy, France, 54519
        • Institut de Cancérologie de Lorraine
      • Nice, France, 06088
        • Centre Antoine Lacassagne
      • Nîmes, France, 30029
        • CHU Caremeau
      • Orléans, France, 45000
        • CHR Orléans La Source
      • Paris, France, 75005
        • Hôpital d'Instruction des Armées du Val de Grâce
      • Paris, France, 75010
        • Hopital Saint Louis
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86021
        • CHU De Poitiers
      • Reims, France, 51056
        • Institut Jean Godinot
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint Gregoire, France, 35760
        • CHP Saint Gregoire
      • Saint Malo, France, 35404
        • Clinique Cote Emeraude
      • Saint-Brieuc, France, 22015
        • Clinique Armoricaine de Radiologie
      • Saint-Herblain, France, 44805
        • Institut de Cancerologie de L'Ouest Rene Gauducheau
      • Saint-Nazaire, France, 44606
        • Clinique Mutualiste de l'Estuaire
      • Saint-Priest-en-Jarez, France, 42271
        • Institut de Cancérologie Lucien Neuwirth
      • Thonon-les-Bains, France, 74200
        • Hôpitaux du Léman
      • Toulouse, France, 31076
        • Groupe Oncorad Garonne
      • Valence, France, 26000
        • Centre Marie Curie
      • Villejuif, France, 94800
        • Gustave Roussy, Cancer Campus, Grand Paris

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage)
  2. R0 or R1
  3. pN0 or pNx
  4. Post prostatectomy PSA ≥0.2 ng/mL measured between 1 month and 4 months after surgery and increasing to a second test performed between 1 et 8 months after the post prostatectomy dosage
  5. PSA ≤2 ng/mL at moment of the randomisation
  6. No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0
  7. Neutrophils ≥1500/mm³; platelet count ≥100 000/mm³
  8. Bilirubin ≤ upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) ≤1.5 ULN
  9. Creatinine <140 µmol/L (or clearance >60 mL/min)
  10. Normal fasting glucose
  11. Eastern Cooperative Oncology Group (ECOG) ≤1
  12. Age >18 years
  13. Life expectancy ≥10 years
  14. Patients with invasive cancer in complete response for more than five years are eligible
  15. Patients who have received the information sheet and signed the informed consent form
  16. Patients with a public or a private health insurance coverage

Exclusion Criteria:

  1. Prostate cancer histology other than adenocarcinoma
  2. Patients pN1, N1 and M1
  3. History of pelvic radiotherapy
  4. Contraindication to pelvic irradiation (eg, scleroderma, chronic inflammatory bowel disease, etc.)
  5. Testosterone ≤0.5 ng/mL
  6. History of surgical castration
  7. Previous treatment by hormonotherapy
  8. Antineoplastic treatment in progress
  9. History of another invasive cancer within 5 years before inclusion (with the exception of a basal cell skin carcinoma treated)
  10. Known pituitary adenoma
  11. Severe hypertension uncontrolled by appropriate treatment (160 mm Hg systolic and/or 90 mm Hg diastolic)
  12. Patient with a corrected QT interval (using Fridericia correction) greater than 450 msec
  13. Individual deprived of liberty or placed under the authority of a tutor
  14. Unable to undergo medical monitoring test for geographical, social or psychological reasons
  15. Known hypersensitivity to the treatment in test
  16. Administration of an investigational therapeutic within 28 days prior to the screening visit or more if treatment is likely to influence the outcome of this

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Radiation

Pelvic radiotherapy

  • 46 Gy in 23 fractions of 2 Gy.
  • prostate only-boost up to 66 Gy
Radiation: Pelvic Radiotherapy
46 Gy in 23 fractions Prostate only-boost up to 66 Gy
Experimental: Radiation and Degarelix

Radiotherapy:

  • 46 Gy in 23 fractions of 2 Gy.
  • prostate only-boost up to 66 Gy

Associated with hormonal therapy by degarelix:

  • beginning in parallel to radiotherapy for 6 months
  • First dose of 240 mg
  • Maintenance dose of 80 mg
Radiation: Pelvic Radiotherapy
46 Gy in 23 fractions Prostate only-boost up to 66 Gy
Drug: Degarelix
First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)
Other Names:
  • Firmagon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
5 years
Survival without biological event
Time Frame: 5 years
Biochemical recurrence was defined as a PSA > nadir + 0.4 ng / mL confirmed by a second PSA> nadir + 0.4 ng / mL in elevation.
5 years
Survival without clinical event
Time Frame: 5 years
The clinical recurrence will be defined by the discovery of a local recurrence in rectal examination, the appearance of metastases by imaging or biopsy, or clinical manifestation associated with malignant disease without elevated PSA but with histological documentation or imaging.
5 years
Survival without metastases
Time Frame: 5 years
5 years
Acute and late toxicities of the association of hormone therapy with radiotherapy
Time Frame: up to 5 years
according CTC-AE v4.0
up to 5 years
Toxicities of radiotherapy
Time Frame: up to 5 years
according CTC-AE v4.0
up to 5 years
Patient Quality of life
Time Frame: up to 5 years after the end of the radiotherapy
QLQ-C30, QLQ-PR25 and IPSS
up to 5 years after the end of the radiotherapy
kinetics of testosterone
Time Frame: up to 12 months after the end of the radiotherapy and after biological release
up to 12 months after the end of the radiotherapy and after biological release

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UNICANCER

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ferring Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Igor LATORZEFF, Clinique Pasteur
  • Principal Investigator: Laurent SALOMON, CHU Henri Mondor
  • Principal Investigator: Paul SARGOS, Institut Bergonie
  • Principal Investigator: Emmanuel MEYER, Centre François Baclesse

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UC-0160/1204
  • 2012-001561-32 (EudraCT Number)

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

product manufactured in and exported from the U.S.

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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