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Adenocarcinoma of ProstatePhase 2GETUG-AFU22NCT01994239

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

A Phase 2 study testing Degarelix and Pelvic Radiotherapy in people with Adenocarcinoma of Prostate, run by UNICANCER at 39 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Adenocarcinoma of Prostate
What is being tested?
Degarelix and Pelvic Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
39 sitesFrance
Study dates
Dec 2012to Mar 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

France39 sites

  • Institut de Cancérologie de l'Ouest -Site Paul Papin

    Angers, 49933

  • Institut Sainte Catherine

    Avignon, 84918

  • Chu Jean Minjoz

    Besançon, 25030

  • Institut Bergonié

    Bordeaux, 33076

  • Centre d'oncologie - Clinique Pasteur

    Brest, 29200

  • Centre François Baclesse

    Caen, 14076

  • Centre hospitalier de Chambéry

    Chambéry, 73011

  • Hôpital Henri Mondor

    Créteil, 94010

  • Centre d'oncologie et de radiothérapie du Parc

    Dijon, 21000

  • Centre Georges François Leclerc

    Dijon, 21079

  • Clinique Sainte-Marguerite

    Hyères, 83400

  • Chd Vendee

    La Roche-sur-Yon, 85925

  • Centre Leon Berard

    Lyon, 69373

  • Clinique Clairval

    Marseille, 13009

  • CHU La Timone - Hôpital Nord

    Marseille, 13385

  • Groupe Oncorad Garonne Clinique Du Pont de Chaume

    Montauban, 82017

  • Ghi Le Raincy / Montfermeil

    Montfermeil, 93370

  • Centre Azureen de Cancerologie

    Mougins, 06250

  • Centre Hospitalier Emile Muller

    Mulhouse, 68070

  • Institut de Cancerologie de Lorraine

    Nancy, 54519

  • Centre Antoine Lacassagne

    Nice, 06088

  • Chu Caremeau

    Nîmes, 30029

  • CHR Orléans La Source

    Orléans, 45000

  • Hôpital d'Instruction des Armées du Val de Grâce

    Paris, 75005

  • Hôpital Saint Louis

    Paris, 75010

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de POITIERS

    Poitiers, 86021

  • Institut Jean Godinot

    Reims, 51056

  • Centre Henri Becquerel

    Rouen, 76038

  • Clinique Armoricaine de Radiologie

    Saint-Brieuc, 22015

  • CHP Saint Grégoire

    Saint-Grégoire, 35760

  • Institut de Cancérologie de l'Ouest René Gauducheau

    Saint-Herblain, 44805

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, 44606

  • Institut de Cancérologie LUCIEN NEUWIRTH

    Saint-Priest-en-Jarez, 42271

  • Clinique Cote Emeraude

    St-Malo, 35404

  • Hôpitaux du Léman

    Thonon-les-Bains, 74200

  • Groupe Oncorad Garonne

    Toulouse, 31076

  • Centre Marie Curie

    Valence, 26000

  • GUSTAVE ROUSSY, Cancer Campus, Grand Paris

    Villejuif, 94800

Other trials in France

About this study

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

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.

Read the 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
Being tested
Degarelix, Pelvic Radiotherapy
Keywords
Prostate-Specific Antigen, LHRH antagonist, Radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DegarelixDrug

    Also called Firmagon

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

  • Pelvic RadiotherapyRadiation

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

Study groups in NCT01994239
Study groupRoleWhat they receive
RadiationActive comparatorPelvic radiotherapy * 46 Gy in 23 fractions of 2 Gy. * prostate only-boost up to 66 Gy
Receives: Radiation: Pelvic Radiotherapy
Radiation and DegarelixExperimentalRadiotherapy: * 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
Receives: Drug: Degarelix; Radiation: Pelvic Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 5 years

Secondary outcomes (8)

  1. 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.

    Measured: 5 years

  2. 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.

    Measured: 5 years

  3. Survival without metastases

    Measured: 5 years

  4. Overall survival

    Measured: 5 years

  5. Acute and late toxicities of the association of hormone therapy with radiotherapy

    according CTC-AE v4.0

    Measured: up to 5 years

  6. Toxicities of radiotherapy

    according CTC-AE v4.0

    Measured: up to 5 years

  7. Patient Quality of life

    QLQ-C30, QLQ-PR25 and IPSS

    Measured: up to 5 years after the end of the radiotherapy

  8. kinetics of testosterone

    Measured: up to 12 months after the end of the radiotherapy and after biological release

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionMar 2022
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01994239
Sponsor's protocol ID
UC-0160/1204
Other IDs
2012-001561-32
Acronym
GETUG-AFU22
Status last verified
Dec 2024
First submitted
16 Oct 2013
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Degarelix and Pelvic Radiotherapy in people with Adenocarcinoma of Prostate, run by UNICANCER at 39 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01994239.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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