Short Darolutamide With Radiation for Intermediate-Risk Prostate Cancer

Trial details

Who runs it

Institut Bergonié

Trial code

NCT05346848EU 2023-509494-23-00

Record updated

8 October 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Previous prostate cancer treated by androgen deprivation, chemotherapy, surgery, or radiotherapy,; Patients with previous orchiectomy; Patients actively receiving or having received within 6 months prior enrollment any concurrent androgens, anti-androgens, estrogens, or progestational agents,; Patients having received ketoconazole, finasteride or dutasteride within 30 days of inclusion,; Previous and current malignancies other than prostate cancer within the last 5 years with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, acute lymphoblastic leukemia, non-muscle invasive bladder cancer,; Major surgery within 4 weeks prior enrolment except pelvic lymph-nodes dissection,; Men who are not using an effective method of contraception as previously described; Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,; Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection),; History of cerebrovascular accident (within the last 6 months); Impaired cardiac function as defined in the Protocol; Uncontrolled hypertension; Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of study drug,; Known hypersensitivity to any involved study drug or of its formulation components, to natural gonadotrophin releasing hormone or its analogues; History of non-compliance to medical regimens or inability to grant consent,; Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL or below the normal range for the institution; Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome; Patients with Gleason score ≥8,; Patients with PSA >20 ng/ml,; Presence of loco-regional or distant metastasis,; Contra-indications to MRI and to contrast-enhanced CT-scan,; Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES,; Patient unable to follow and comply with the study procedures because of any geographical, social or psychpsychological reasons,; Individuals under judicial protection or deprived of liberty; Inability to swallow or to give subcutaneous or intramuscular injections.

ClinicalTrials.gov NCT05346848 · EU CTIS 2023-509494-23-00