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New treatment option for Prostate Cancer
Official title Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer
ClinicalTrials.gov ID: NCT05346848
What this study is testing
What is Association of darolutamide and EBRT?
Association of darolutamide and EBRT is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines. One of the following criteria is sufficient to define an...
- Gleason = 7 (4+3)
You likely can't join if
- Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,
- 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,
- Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL or below the normal range for the...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
- Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,
- 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,
- Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL or below the normal range for the institution.
- 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...
- 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,
- Major surgery within 4 weeks prior enrolment except pelvic lymph-nodes dissection,
- Known hypersensitivity to any involved study drug or of its formulation components, to natural gonadotrophin releasing hormone or its analogues
- Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome
- Men who are not using an effective method of contraception as previously described
- Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES,
- History of non-compliance to medical regimens or inability to grant consent,
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Avignon, France
- Besançon, France
- Bordeaux, France
- Brest, France
- Marseille, France
- Paris, France
- Saint-Grégoire, France
- Saint-Herblain, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Avignon, France; Besançon, France; Bordeaux, France; Brest, France; Marseille, France; Paris, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.