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

Sponsor
UNICANCER (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01994239
Collaborator
Ferring Pharmaceuticals (Industry)
120
Enrollment
39
Locations
2
Arms
147
Anticipated Duration (Months)
3.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

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

Drug: Degarelix
First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)
Other Names:
  • Firmagon

    • Radiation: Pelvic Radiotherapy
    46 Gy in 23 fractions Prostate only-boost up to 66 Gy

    Outcome Measures

    Primary Outcome Measures

    1. The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival [5 years]

    Secondary Outcome Measures

    1. Survival without biological event [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.

    2. Survival without clinical event [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.

    3. Survival without metastases [5 years]

    4. Overall survival [5 years]

    5. Acute and late toxicities of the association of hormone therapy with radiotherapy [up to 5 years]

      according CTC-AE v4.0

    6. Toxicities of radiotherapy [up to 5 years]

      according CTC-AE v4.0

    7. Patient Quality of life [up to 5 years after the end of the radiotherapy]

      QLQ-C30, QLQ-PR25 and IPSS

    8. kinetics of testosterone [up to 12 months after the end of the radiotherapy and after biological release]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut de Cancérologie de l'Ouest -Site Paul Papin Angers France 49933
    2 Institut Sainte Catherine Avignon France 84918
    3 Chu Jean Minjoz Besançon France 25030
    4 Institut Bergonié Bordeaux France 33076
    5 Centre d'oncologie - Clinique Pasteur Brest France 29200
    6 Centre François Baclesse Caen France 14076
    7 Centre hospitalier de Chambéry Chambéry France 73011
    8 Hôpital Henri Mondor Créteil France 94010
    9 Centre d'oncologie et de radiothérapie du Parc Dijon France 21000
    10 Centre Georges François Leclerc Dijon France 21079
    11 Clinique Sainte-Marguerite Hyeres France 83400
    12 Chd Vendee La Roche-sur-Yon France 85925
    13 Centre Leon Berard Lyon France 69373
    14 Clinique Clairval Marseille France 13009
    15 CHU La Timone - Hôpital Nord Marseille France 13385
    16 Groupe Oncorad Garonne Clinique Du Pont de Chaume Montauban France 82017
    17 Ghi Le Raincy / Montfermeil Montfermeil France 93370
    18 Centre Azureen de Cancerologie Mougins France 06250
    19 Centre Hospitalier Emile Muller Mulhouse France 68070
    20 Institut de Cancerologie de Lorraine Nancy France 54519
    21 Centre Antoine Lacassagne Nice France 06088
    22 Chu Caremeau Nîmes France 30029
    23 CHR Orléans La Source Orléans France 45000
    24 Hôpital d'Instruction des Armées du Val de Grâce Paris France 75005
    25 Hôpital Saint Louis Paris France 75010
    26 Centre Hospitalier Lyon Sud Pierre-Bénite France 69495
    27 CHU de POITIERS Poitiers France 86021
    28 Institut Jean Godinot Reims France 51056
    29 Centre Henri Becquerel Rouen France 76038
    30 CHP Saint Grégoire Saint Gregoire France 35760
    31 Clinique Cote Emeraude Saint Malo France 35404
    32 Clinique Armoricaine de Radiologie Saint-Brieuc France 22015
    33 Institut de Cancérologie de l'Ouest René Gauducheau Saint-Herblain France 44805
    34 Clinique Mutualiste de l'Estuaire Saint-Nazaire France 44606
    35 Institut de Cancérologie LUCIEN NEUWIRTH Saint-Priest-en-Jarez France 42271
    36 Hôpitaux du Léman Thonon-les-Bains France 74200
    37 Groupe Oncorad Garonne Toulouse France 31076
    38 Centre Marie Curie Valence France 26000
    39 GUSTAVE ROUSSY, Cancer Campus, Grand Paris Villejuif France 94800

    Sponsors and Collaborators

    • UNICANCER
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    UNICANCER
    ClinicalTrials.gov Identifier:
    NCT01994239
    Other Study ID Numbers:
    • UC-0160/1204
    • 2012-001561-32
    First Posted:
    Nov 25, 2013
    Last Update Posted:
    May 12, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by UNICANCER
    Prostate-Specific Antigen
    LHRH antagonist
    Radiotherapy
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of May 12, 2022