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New treatment option for High-Risk Localized Prostate Cancer
Official title A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
ClinicalTrials.gov ID: NCT07450599
What this study is testing
What is Darolutamide?
Darolutamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for high-risk localized 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
- Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make it more likely to grow and spread. The study treatment darolutamide plus androgen deprivation therapy (ADT) is under development as treatment before surgery for men who have high-risk localized prostate cancer.
- Phase 2: a mid-size study of how well it works
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
- Participants must be 18 years or older at the time of signing the informed consent.
- Darolutamide-naïve participants who are with localized prostate adenocarcinoma who plan to receive radical prostatectomy (RP) and defined as high...
- No evidence of distant metastasis based on computed tomography (CT), magnetic resonance imaging (MRI), and whole body bone scan (WBBS) within 42 days...
- Candidate for RP with pelvic lymph node dissection (PLND) or extended PLND (ePLND) as per the investigator.
- Participants must have at least one of the following features according to NCCN definition of high-risk:
You likely can't join if
- Prostate cancer with known neuroendocrine (NE) differentiation or small cell features.
- Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of the chest, pelvis, and...
- Intolerant to darolutamide or androgen deprivation therapy (ADT) treatment.
- History of
- Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomization, or
- Significant cardiovascular disease within 6 months prior to randomization.
See the full eligibility criteria
- Participants must be 18 years or older at the time of signing the informed consent.
- Darolutamide-naïve participants who are with localized prostate adenocarcinoma who plan to receive radical prostatectomy (RP) and defined as high risk with National Comprehensive Cancer Network (NCCN) criteria (version...
- No evidence of distant metastasis based on computed tomography (CT), magnetic resonance imaging (MRI), and whole body bone scan (WBBS) within 42 days prior to start of study treatment.
- Candidate for RP with pelvic lymph node dissection (PLND) or extended PLND (ePLND) as per the investigator.
- Participants must have at least one of the following features according to NCCN definition of high-risk:
- Biopsy Gleason score ≥8, and/or
- Prostate-specific antigen (PSA) \>20 ng/mL measured during Screening and prior to randomization, or
- Clinical stage ≥ T3a.
- Participants with pelvic lymph node involvement (N1) can be included.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Prostate cancer with known neuroendocrine (NE) differentiation or small cell features.
- Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of the chest, pelvis, and the abdomen (CT or MRI with intravenous [IV] contrast), and WBBS. Nodal...
- Intolerant to darolutamide or androgen deprivation therapy (ADT) treatment.
- History of
- Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomization, or
- Significant cardiovascular disease within 6 months prior to randomization.
- Any contraindications for RP.
- Uncontrolled or treatment-resistant hypertension.
- History of another malignancy within 5 years prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Kunming, Yunnan, China
- Jinhua, Zhejiang, China
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 Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Shijiazhuang, Hebei, China and 12 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.