New combo therapy aims to knock down prostate cancer quickly
NCT ID NCT05346848
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with a certain type of prostate cancer that is not too advanced but has some higher-risk features. It tests whether adding a short course of the drug darolutamide to standard radiation therapy can lower PSA levels to a very low target (0.1 ng/mL or less) at 6 months. About 62 participants will receive the combination, and researchers will monitor how well it controls the cancer over time.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18, 2. Histological diagnosis of prostate malignancy cancer 3. 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), 4. 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 . 5. 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 6. Patients must have a life expectancy of at least 5 years, 7. Performance status ECOG ≤ 2, 8. Patients without contra-indications to EBRT as per physician judgement, 9. Patients with adequate organ function defined by all the following laboratory values 10. Available archived paraffin-embedded tumor sample for research purpose, 11. Patients with a social security in compliance with the french law, 12. Voluntary signed and dated written informed consent prior to any study specific procedure, 13. Men must agree to use an effective method of contraception throughout the treatment period and for one week after discontinuation of treatment. Exclusion Criteria: 1. Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation, 2. Patients with Gleason score ≥8, 3. Patients with PSA \>20 ng/ml, 4. Presence of loco-regional or distant metastasis, 5. Contra-indications to MRI and to contrast-enhanced CT-scan, 6. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL or below the normal range for the institution. 7. Previous prostate cancer treated by androgen deprivation, chemotherapy, surgery, or radiotherapy, 8. Patients with previous orchiectomy 9. Patients actively receiving or having received within 6 months prior enrollment any concurrent androgens, anti-androgens, estrogens, or progestational agents, 10. Patients having received ketoconazole, finasteride or dutasteride within 30 days of inclusion, 11. 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, 12. Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection), 13. History of cerebrovascular accident (within the last 6 months) 14. Impaired cardiac function as defined in the Protocol 15. Uncontrolled hypertension 16. Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of study drug, 17. Major surgery within 4 weeks prior enrolment except pelvic lymph-nodes dissection, 18. Known hypersensitivity to any involved study drug or of its formulation components, to natural gonadotrophin releasing hormone or its analogues 19. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome 20. Men who are not using an effective method of contraception as previously described 21. Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES, 22. History of non-compliance to medical regimens or inability to grant consent, 23. Patient unable to follow and comply with the study procedures because of any geographical, social or psychpsychological reasons, 24. Individuals under judicial protection or deprived of liberty. 25. Inability to swallow or to give subcutaneous or intramuscular injections.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Assitance Publique des Hôpitaux de Marseille - CHU La Timone
NOT_YET_RECRUITINGMarseille, 13385, France
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CHP Saint-Grégoire
NOT_YET_RECRUITINGSaint-Grégoire, 35760, France
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CHRU Besançon
NOT_YET_RECRUITINGBesançon, 25030, France
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CHRU Brest - Hôpital Morvan
NOT_YET_RECRUITINGBrest, 29200, France
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Clinique Pasteur
NOT_YET_RECRUITINGToulouse, 31076, France
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Hôpital de la Pitié Salpétrière
NOT_YET_RECRUITINGParis, 75651, France
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IUCT Oncopôle
NOT_YET_RECRUITINGToulouse, 31059, France
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Institut Bergonie
RECRUITINGBordeaux, 33076, France
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Institut de Cancérologie de l'Ouest - Site René Gauducheau
NOT_YET_RECRUITINGSaint-Herblain, 44805, France
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Sainte Catherine, Institut du Cancer Avignon-Provence
NOT_YET_RECRUITINGAvignon, 84918, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains