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

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: Active, not recruiting
• Conditions: Adenocarcinoma of Prostate
• Intervention / Treatment: Radiation: Pelvic Radiotherapy; Drug: Degarelix

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: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

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 Bergonié
  • Brest, France, 29200
    • Centre d'oncologie - Clinique Pasteur
  • Caen, France, 14076
    • Centre François Baclesse
  • Chambéry, France, 73011
    • Centre Hospitalier de Chambéry
  • Créteil, France, 94010
    • Hopital 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 Azureen de Cancerologie
  • 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 Carémeau
  • Orléans, France, 45000
    • CHR Orléans La Source
  • Paris, France, 75005
    • Hôpital d'Instruction des Armées du Val de Grâce
  • Paris, France, 75010
    • Hôpital 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 Cancérologie de l'Ouest René 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		5 years
Survival without biological event	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	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		5 years
Acute and late toxicities of the association of hormone therapy with radiotherapy	according CTC-AE v4.0	up to 5 years
Toxicities of radiotherapy	according CTC-AE v4.0	up to 5 years
Patient Quality of life	QLQ-C30, QLQ-PR25 and IPSS	up to 5 years after the end of the radiotherapy
kinetics of testosterone		up to 12 months after the end of the radiotherapy and after biological release

Collaborators and Investigators

• Sponsor: UNICANCER
• Collaborators: Ferring Pharmaceuticals
• Investigators: Principal Investigator: Igor LATORZEFF, Clinique Pasteur; Principal Investigator: Laurent SALOMON, CHU Henri Mondor; Principal Investigator: Paul SARGOS, Institut Bergonié; Principal Investigator: Emmanuel MEYER, Centre François Baclesse

Publications and helpful links

Helpful Links

• Site UNICANCER

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): March 1, 2022
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimated): November 25, 2013

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Radiotherapy; Prostate-Specific Antigen; LHRH antagonist
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID 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