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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adenocarcinoma of Prostate | Drug: Degarelix Radiation: Pelvic Radiotherapy | Phase 2 |
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 (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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Radiation
Pelvic radiotherapy
|
Radiation: Pelvic Radiotherapy
46 Gy in 23 fractions Prostate only-boost up to 66 Gy |
Experimental: Radiation and Degarelix
Radiotherapy:
Associated with hormonal therapy by degarelix:
|
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 |
- The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival [ Time Frame: 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.
- 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.
- Survival without metastases [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 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
- Toxicities of radiotherapy [ Time Frame: up to 5 years ]according CTC-AE v4.0
- Quality of life [ Time Frame: up to 5 years after the end of the radiotherapy ]QLQ-C30, QLQ-PR25 and IPSS
- kinetics of testosterone [ Time Frame: up to 12 months after the end of the radiotherapy and after biological release ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage)
- R0 or R1
- pN0 or pNx
- 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
- PSA ≤2 ng/mL at moment of the randomisation
- No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0
- Neutrophils ≥1500/mm³; platelet count ≥100 000/mm³
- Bilirubin ≤ upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) ≤1.5 ULN
- Creatinine <140 µmol/L (or clearance >60 mL/min)
- Normal fasting glucose
- Eastern Cooperative Oncology Group (ECOG) ≤1
- Age >18 years
- Life expectancy ≥10 years
- Patients with invasive cancer in complete response for more than five years are eligible
- Patients who have received the information sheet and signed the informed consent form
- Patients with a public or a private health insurance coverage
Exclusion Criteria:
- Prostate cancer histology other than adenocarcinoma
- Patients pN1, N1 and M1
- History of pelvic radiotherapy
- Contraindication to pelvic irradiation (eg, scleroderma, chronic inflammatory bowel disease, etc.)
- Testosterone ≤0.5 ng/mL
- History of surgical castration
- Previous treatment by hormonotherapy
- Antineoplastic treatment in progress
- History of another invasive cancer within 5 years before inclusion (with the exception of a basal cell skin carcinoma treated)
- Known pituitary adenoma
- Severe hypertension uncontrolled by appropriate treatment (160 mm Hg systolic and/or 90 mm Hg diastolic)
- Patient with a corrected QT interval (using Fridericia correction) greater than 450 msec
- Individual deprived of liberty or placed under the authority of a tutor
- Unable to undergo medical monitoring test for geographical, social or psychological reasons
- Known hypersensitivity to the treatment in test
- 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

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

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 |
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. |
Prostate-Specific Antigen LHRH antagonist Radiotherapy |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |