A Randomized Non-comparative Phase II Multicentric Trial on Short Term Darolutamide (ODM-201) Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18,

• Histological diagnosis of prostate malignancy cancer

• Cancer without loco-regional or distant metastasis (tumor assessment must comprise at least Pelvic MRI AND thoraco-abdomino-pelvic contrast-enhanced CT-Scan AND Bone Scintigraphy. (Note that additional assessment by PET-Scan is allowed as per investigator judgement),

• Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines.

• One of the following criteria is sufficient to define an unfavorable intermediate risk prostate cancer:

⁃ Gleason = 7 (4+3)

⁃ ≥ 50% of thecore of biopsies need to be positive for adenocarcinoma

• If these criteria are not being identified, two or three of the following criteria are necessary to define unfavorable intermediate risk prostate cancer:

⁃ PSA value between 10-20 ng/ml

⁃ Gleason 7 (3+4) or 6

⁃ T2b (clinical or radiological) Note: patients with iT3a can be included only if gleason score is 6 and PSA less than 20 .

• Patients newly diagnosed with an unfavorable intermediate risk prostate cancer according to the protocol criteria or previously diagnosed with low risk (Gleason score \< 6, clinical stage \< T2a, and PSA\< 10) prostate cancer progressing to eligible risk disease according to the protocol criteria within 30 days before registration

• Patients must have a life expectancy of at least 5 years,

• Performance status ECOG ≤ 2,

• Patients without contra-indications to EBRT as per physician judgement,

• Patients with adequate organ function defined by all the following laboratory values

⁃ Available archived paraffin-embedded tumor sample for research purpose,

⁃ Patients with a social security in compliance with the french law,

⁃ Voluntary signed and dated written informed consent prior to any study specific procedure,

⁃ Men must agree to use an effective method of contraception throughout the treatment period and for one week after discontinuation of treatment.

Locations
Other Locations
France
Sainte Catherine, Institut du Cancer Avignon-Provence
NOT_YET_RECRUITING
Avignon
CHRU Besançon
NOT_YET_RECRUITING
Besançon
Institut Bergonie
RECRUITING
Bordeaux
CHRU Brest - Hôpital Morvan
NOT_YET_RECRUITING
Brest
Assitance Publique des Hôpitaux de Marseille - CHU La Timone
NOT_YET_RECRUITING
Marseille
Hôpital de la Pitié Salpétrière
NOT_YET_RECRUITING
Paris
CHP Saint-Grégoire
NOT_YET_RECRUITING
Saint-grégoire
Institut de Cancérologie de l'Ouest - Site René Gauducheau
NOT_YET_RECRUITING
Saint-herblain
Clinique Pasteur
NOT_YET_RECRUITING
Toulouse
IUCT Oncopôle
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Paul SARGOS, MD
p.sargos@bordeaux.unicancer.fr
+33556333333
Backup
Simone MATHOULIN-PELISSIER, MD, PhD
s.mathoulin@bordeaux.unicancer.fr
Time Frame
Start Date: 2023-02-24
Estimated Completion Date: 2030-02
Participants
Target number of participants: 62
Treatments
Experimental: Experimental Arm A: combination of radiotherapy and darolutamide
Patients with unfavorable intermediate risk prostate cancer will be treated with darolutamide for a maximum of 6 months combined with external beam radiotherapy
Other: Standard Arm B: combination of radiotherapy and androgen deprivation therapy
Patients with unfavorable intermediate risk prostate cancer will be treated with androgen deprivation therapy (ADT) as per market authorization combined with external beam radiotherapy
Related Therapeutic Areas
Sponsors
Collaborators: Bayer
Leads: Institut Bergonié

This content was sourced from clinicaltrials.gov