Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT05346848

Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

Led by Institut Bergonié · Updated on 2025-10-02

62

Participants Needed

10

Research Sites

362 weeks

Total Duration

On this page

Sponsors

I

Institut Bergonié

Lead Sponsor

B

Bayer

Collaborating Sponsor

AI-Summary

What this Trial Is About

Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.

CONDITIONS

Official Title

Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histological diagnosis of prostate cancer
  • No loco-regional or distant metastasis confirmed by pelvic MRI, contrast-enhanced CT scan, and bone scintigraphy
  • Diagnosis of unfavorable intermediate risk prostate cancer based on NCCN guidelines, including Gleason score 7 (4+3) or at least 50% positive biopsy cores, or a combination of PSA 10-20 ng/ml, Gleason 7 (3+4) or 6, and clinical or radiological T2b
  • Newly diagnosed or progressed to eligible risk disease within 30 days before registration
  • Life expectancy of at least 5 years
  • ECOG performance status 0 to 2
  • No contraindications to external beam radiotherapy
  • Adequate organ function based on laboratory values
  • Availability of archived tumor sample for research
  • Social security compliant with French law
  • Signed informed consent
  • Agreement to use effective contraception during treatment and for one week after treatment ends
Not Eligible

You will not qualify if you...

  • Clinical or radiologic stage T3b-T4 prostate cancer
  • Gleason score 8 or higher
  • PSA level greater than 20 ng/ml
  • Presence of loco-regional or distant metastasis
  • Contraindications to MRI or contrast-enhanced CT scan
  • Hypogonadism or severe androgen deficiency
  • Previous prostate cancer treatment with androgen deprivation, chemotherapy, surgery, or radiotherapy
  • Previous orchiectomy
  • Use of androgens, anti-androgens, estrogens, or progestational agents within 6 months prior to enrollment
  • Use of ketoconazole, finasteride, or dutasteride within 30 days before inclusion
  • Other malignancies within last 5 years except certain skin cancers, acute lymphoblastic leukemia, or non-muscle invasive bladder cancer
  • Severe or uncontrolled medical conditions
  • Recent cerebrovascular accident (within 6 months)
  • Impaired cardiac function
  • Uncontrolled hypertension
  • Gastrointestinal conditions affecting drug absorption
  • Major surgery within 4 weeks prior to enrollment except pelvic lymph-node dissection
  • Known hypersensitivity to study drugs or related compounds
  • Specific metabolic intolerances (galactose intolerance, lactase deficiency, glucose-galactose malabsorption)
  • Not using effective contraception as required
  • Use of herbal or alternative remedies affecting hormones
  • History of non-compliance or inability to consent
  • Inability to follow study procedures due to social, geographic, or psychological reasons
  • Under judicial protection or deprived of liberty
  • Inability to swallow or receive injections

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Sainte Catherine, Institut du Cancer Avignon-Provence

Avignon, France, 84918

Not Yet Recruiting

2

CHRU Besançon

Besançon, France, 25030

Not Yet Recruiting

3

Institut Bergonie

Bordeaux, France, 33076

Actively Recruiting

4

CHRU Brest - Hôpital Morvan

Brest, France, 29200

Not Yet Recruiting

5

Assitance Publique des Hôpitaux de Marseille - CHU La Timone

Marseille, France, 13385

Not Yet Recruiting

6

Hôpital de la Pitié Salpétrière

Paris, France, 75651

Not Yet Recruiting

7

CHP Saint-Grégoire

Saint-Grégoire, France, 35760

Not Yet Recruiting

8

Institut de Cancérologie de l'Ouest - Site René Gauducheau

Saint-Herblain, France, 44805

Not Yet Recruiting

9

IUCT Oncopôle

Toulouse, France, 31059

Not Yet Recruiting

10

Clinique Pasteur

Toulouse, France, 31076

Not Yet Recruiting

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Research Team

P

Paul SARGOS, MD

CONTACT

S

Simone MATHOULIN-PELISSIER, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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