Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy

Phase 2

Active, not recruiting

• Conditions: Adenocarcinoma of Prostate
• Interventions: Drug: Degarelix; Radiation: Pelvic Radiotherapy

• Registration Number: NCT01994239
• Lead Sponsor: UNICANCER

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.

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-25
• Primary Completion: 2022-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiation and Degarelix	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 and Degarelix	Pelvic Radiotherapy	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	Pelvic radiotherapy * 46 Gy in 23 fractions of 2 Gy. * prostate only-boost up to 66 Gy

Primary Outcome Measures

Name	Time	Method
The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (39)

Hôpital Saint Louis; 🇫🇷 Paris, France

Clinique Sainte-Marguerite; 🇫🇷 Hyeres, France

Institut de Cancérologie de l'Ouest -Site Paul Papin; 🇫🇷 Angers, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Chu Jean Minjoz; 🇫🇷 Besançon, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre d'oncologie - Clinique Pasteur; 🇫🇷 Brest, France

Ghi Le Raincy / Montfermeil; 🇫🇷 Montfermeil, France

Institut de Cancerologie de Lorraine; 🇫🇷 Nancy, France

Centre Leon Berard; 🇫🇷 Lyon, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Chd Vendee; 🇫🇷 La Roche-sur-Yon, France

Groupe Oncorad Garonne; 🇫🇷 Toulouse, France

CHU La Timone - Hôpital Nord; 🇫🇷 Marseille, France

Groupe Oncorad Garonne Clinique Du Pont de Chaume; 🇫🇷 Montauban, France

Hôpitaux du Léman; 🇫🇷 Thonon-les-Bains, France

Hôpital d'Instruction des Armées du Val de Grâce; 🇫🇷 Paris, France

Centre Azureen de Cancerologie; 🇫🇷 Mougins, France

Chu Caremeau; 🇫🇷 Nîmes, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

CHU de POITIERS; 🇫🇷 Poitiers, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Clinique Mutualiste de l'Estuaire; 🇫🇷 Saint-Nazaire, France

Institut de Cancérologie LUCIEN NEUWIRTH; 🇫🇷 Saint-Priest-en-Jarez, France

Centre d'oncologie et de radiothérapie du Parc; 🇫🇷 Dijon, France

Clinique Cote Emeraude; 🇫🇷 Saint Malo, France

Clinique Armoricaine de Radiologie; 🇫🇷 Saint-Brieuc, France

Institut de Cancérologie de l'Ouest René Gauducheau; 🇫🇷 Saint-Herblain, France

Centre Marie Curie; 🇫🇷 Valence, France

Institut Bergonié; 🇫🇷 Bordeaux, France

CHR Orléans La Source; 🇫🇷 Orléans, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre hospitalier de Chambéry; 🇫🇷 Chambéry, France

Clinique Clairval; 🇫🇷 Marseille, France

Centre Hospitalier Emile Muller; 🇫🇷 Mulhouse, France

CHP Saint Grégoire; 🇫🇷 Saint Gregoire, France

GUSTAVE ROUSSY, Cancer Campus, Grand Paris; 🇫🇷 Villejuif, France