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

Adenocarcinoma of Prostate Clinical Trial

— GETUG-AFU22  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01994239
• Other study ID #: UC-0160/1204
• Secondary ID: 2012-001561-32
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2025
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Prostate

Intervention

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

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

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest -Site Paul Papin	Angers
France	Institut Sainte Catherine	Avignon
France	Chu Jean Minjoz	Besançon
France	Institut Bergonié	Bordeaux
France	Centre d'oncologie - Clinique Pasteur	Brest
France	Centre François Baclesse	Caen
France	Centre hospitalier de Chambéry	Chambéry
France	Hôpital Henri Mondor	Créteil
France	Centre d'oncologie et de radiothérapie du Parc	Dijon
France	Centre Georges François Leclerc	Dijon
France	Clinique Sainte-Marguerite	Hyeres
France	Chd Vendee	La Roche-sur-Yon
France	Centre Leon Berard	Lyon
France	CHU La Timone - Hôpital Nord	Marseille
France	Clinique Clairval	Marseille
France	Groupe Oncorad Garonne Clinique Du Pont de Chaume	Montauban
France	Ghi Le Raincy / Montfermeil	Montfermeil
France	Centre Azureen de Cancerologie	Mougins
France	Centre Hospitalier Emile Muller	Mulhouse
France	Institut de Cancerologie de Lorraine	Nancy
France	Centre Antoine Lacassagne	Nice
France	Chu Caremeau	Nîmes
France	CHR Orléans La Source	Orléans
France	Hôpital d'Instruction des Armées du Val de Grâce	Paris
France	Hôpital Saint Louis	Paris
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	CHU de POITIERS	Poitiers
France	Institut Jean Godinot	Reims
France	Centre Henri Becquerel	Rouen
France	CHP Saint Grégoire	Saint Gregoire
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	Clinique Mutualiste de l'Estuaire	Saint-Nazaire
France	Institut de Cancérologie LUCIEN NEUWIRTH	Saint-Priest-en-Jarez
France	Hôpitaux du Léman	Thonon-les-Bains
France	Groupe Oncorad Garonne	Toulouse
France	Centre Marie Curie	Valence
France	GUSTAVE ROUSSY, Cancer Campus, Grand Paris	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
UNICANCER	Ferring Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival		5 years
Secondary	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
Secondary	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
Secondary	Survival without metastases		5 years
Secondary	Overall survival		5 years
Secondary	Acute and late toxicities of the association of hormone therapy with radiotherapy	according CTC-AE v4.0	up to 5 years
Secondary	Toxicities of radiotherapy	according CTC-AE v4.0	up to 5 years
Secondary	Patient Quality of life	QLQ-C30, QLQ-PR25 and IPSS	up to 5 years after the end of the radiotherapy
Secondary	kinetics of testosterone		up to 12 months after the end of the radiotherapy and after biological release

External Links

•   Site UNICANCER