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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994239
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
UNICANCER

Study Description
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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
Adenocarcinoma of Prostate Drug: Degarelix Radiation: Pelvic Radiotherapy 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : December 2012
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Degarelix

Arms and Interventions
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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 Name: Firmagon

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


Outcome Measures
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Primary Outcome Measures :
  1. The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Survival without metastases [ Time Frame: 5 years ]
  4. Overall survival [ Time Frame: 5 years ]
  5. Acute and late toxicities of the association of hormone therapy with radiotherapy [ Time Frame: up to 5 years ]
    according CTC-AE v4.0

  6. Toxicities of radiotherapy [ Time Frame: up to 5 years ]
    according CTC-AE v4.0

  7. Quality of life [ Time Frame: up to 5 years after the end of the radiotherapy ]
    QLQ-C30, QLQ-PR25 and IPSS

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994239


Locations
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Sponsors and Collaborators
UNICANCER
Ferring Pharmaceuticals
Investigators
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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
More Information
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Additional Information:

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01994239    
Other Study ID Numbers: UC-0160/1204
2012-001561-32 ( EudraCT Number )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by UNICANCER:
Prostate-Specific Antigen
LHRH antagonist
Radiotherapy
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms