Current partner codePEPTIDESDE
NCT01994239·Phase 2·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 2

Enrollment

120

Locations

39

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Nov 25, 2013

  2. Study start

    Dec 2012

  3. Primary completion

    Mar 2022

  4. Study completion

    Mar 2025

  5. Results posted

    Not reported

  6. Registry updated

    Dec 16, 2024

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 5 years

Secondary outcomes

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

Patient 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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

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 locations

39 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

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

Hyères, France

Chd Vendee

La Roche-sur-Yon, France

Centre Leon Berard

Lyon, France

Clinique Clairval

Marseille, France

CHU La Timone - Hôpital Nord

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Degarelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.