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

NCT01994239 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: UC-0160/12042012-001561-32
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 39

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.

Conditions

Adenocarcinoma of Prostate

Keywords

Prostate-Specific Antigen; LHRH antagonist; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival

  5 years

Secondary Outcomes (8)

• Survival without biological event

  5 years

• Survival without clinical event

  5 years

• Survival without metastases

  5 years

• Overall survival

  5 years

• Acute and late toxicities of the association of hormone therapy with radiotherapy

  up to 5 years

Study Arms (2)

Radiation

ACTIVE COMPARATOR

Pelvic radiotherapy * 46 Gy in 23 fractions of 2 Gy. * prostate only-boost up to 66 Gy

Radiation: Pelvic Radiotherapy

Radiation and Degarelix

EXPERIMENTAL

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; Radiation: Pelvic Radiotherapy

Interventions

Degarelix DRUG

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

Also known as: Firmagon

Radiation and Degarelix

Pelvic Radiotherapy RADIATION

46 Gy in 23 fractions Prostate only-boost up to 66 Gy

Radiation; Radiation and Degarelix

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• UNICANCER: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (39)

Institut de Cancérologie de l'Ouest -Site Paul Papin

Angers, 49933, France

Location

Institut Sainte Catherine

Avignon, 84918, France

Location

Chu Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre d'oncologie - Clinique Pasteur

Brest, 29200, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre hospitalier de Chambéry

Chambéry, 73011, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Centre d'oncologie et de radiothérapie du Parc

Dijon, 21000, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Clinique Sainte-Marguerite

Hyères, 83400, France

Location

Chd Vendee

La Roche-sur-Yon, 85925, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Clinique Clairval

Marseille, 13009, France

Location

CHU La Timone - Hôpital Nord

Marseille, 13385, France

Location

Groupe Oncorad Garonne Clinique Du Pont de Chaume

Montauban, 82017, France

Location

Ghi Le Raincy / Montfermeil

Montfermeil, 93370, France

Location

Centre Azureen de Cancerologie

Mougins, 06250, France

Location

Centre Hospitalier Emile Muller

Mulhouse, 68070, France

Location

Institut de Cancerologie de Lorraine

Nancy, 54519, France

Location

Centre Antoine Lacassagne

Nice, 06088, France

Location

Chu Caremeau

Nîmes, 30029, France

Location

CHR Orléans La Source

Orléans, 45000, France

Location

Hôpital d'Instruction des Armées du Val de Grâce

Paris, 75005, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de POITIERS

Poitiers, 86021, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Clinique Armoricaine de Radiologie

Saint-Brieuc, 22015, France

Location

CHP Saint Grégoire

Saint-Grégoire, 35760, France

Location

Institut de Cancérologie de l'Ouest René Gauducheau

Saint-Herblain, 44805, France

Location

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, 44606, France

Location

Institut de Cancérologie LUCIEN NEUWIRTH

Saint-Priest-en-Jarez, 42271, France

Location

Clinique Cote Emeraude

St-Malo, 35404, France

Location

Hôpitaux du Léman

Thonon-les-Bains, 74200, France

Location

Groupe Oncorad Garonne

Toulouse, 31076, France

Location

Centre Marie Curie

Valence, 26000, France

Location

GUSTAVE ROUSSY, Cancer Campus, Grand Paris

Villejuif, 94800, France

Location

Related Links

• Site UNICANCER

MeSH Terms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Study Officials

• Igor LATORZEFF

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

• Laurent SALOMON

  CHU Henri Mondor

  PRINCIPAL INVESTIGATOR

• Paul SARGOS

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

• Emmanuel MEYER

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (39)