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New treatment option for Locally Advanced Prostate Cancer
Official title Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)
ClinicalTrials.gov ID: NCT06387056
What this study is testing
What is Rezvilutamide?
Rezvilutamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for locally advanced 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
- To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic 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
- Males ≥ 18 years of age;
- Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a...
- Imaging examination (defined by multiparametric magnetic resonance imaging, radionuclide bone scan and PSMA PET/CT (prostate-specific membrane...
- Histologically confirmed adenocarcinoma of the prostate without pathologic evidence of small cell and neuroendocrine differentiation at the time of...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and a life expectancy of ≥ 3 years;
You likely can't join if
- Participants with a history of hypersensitivity to any of the relevant drugs involved in this study;
- Participants received more than 28 days of LHRHa, non-steroidal anti-androgen (NSAA) and novel hormone therapy (rezvilutamide) prior to registration...
- Participants received local treatments of primary or metastatic lesions prior to enrollment;
- Participants received bilateral orchiectomy prior to enrollment;
- Hypogonadism or severe androgen deficiency as defined by screening serum testosterone more than 50 ng/dL below the normal range for the institution;
- Participants with a history of brain metastases or epilepsy;
See the full eligibility criteria
- Males ≥ 18 years of age;
- Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness...
- Imaging examination (defined by multiparametric magnetic resonance imaging, radionuclide bone scan and PSMA PET/CT (prostate-specific membrane antigen positron emission tomography/computed tomography) confirmed locally...
- Histologically confirmed adenocarcinoma of the prostate without pathologic evidence of small cell and neuroendocrine differentiation at the time of initial diagnosis;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and a life expectancy of ≥ 3 years;
- Participants must have adequate end-organ function to tolerate NT and subsequent RP+PLND and all laboratory tests must be performed within 4 weeks prior to registration into master protocol. Including the following...
- Participants must consent to genetic testing at registration and prior to enrolment in the trial;
- No prior systemic or localized treatment for prostate cancer. Up to 28 days of LHRHa, non-steroidal anti-androgen (NSAA) and novel hormone therapy (rezvilutamide) are allowable prior to treatment;
- Participants must have the ability to swallow oral medication and follow the study procedure;
- Participants must consent to use reliable contraceptive methods (such as condoms) and not to donate sperm throughout the study period and for 3 months after the last NT administration;
- Participants must have no contraindications to any of the relevant drug treatments in the study.
- Participants with a history of hypersensitivity to any of the relevant drugs involved in this study;
- Participants received more than 28 days of LHRHa, non-steroidal anti-androgen (NSAA) and novel hormone therapy (rezvilutamide) prior to registration, or enrolled in any other clinical studies for therapeutic purposes...
- Participants received local treatments of primary or metastatic lesions prior to enrollment;
- Participants received bilateral orchiectomy prior to enrollment;
- Hypogonadism or severe androgen deficiency as defined by screening serum testosterone more than 50 ng/dL below the normal range for the institution;
- Participants with a history of brain metastases or epilepsy;
- Participants with severe cardiovascular disease, including: myocardial infarction or thrombosis in the previous 6 months; known unstable angina; history of documented congestive heart failure (New York Heart Association...
- Participants with clinically significant digestive tract abnormalities that may affect the process of drug intake, transport, or absorption (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc., or...
- Participants with other clinically significant co-morbidities evaluated by the investigator, including uncontrolled lung disease, active central nervous system disease, active or uncontrolled bacterial, viral, or fungal...
- Participants with other known active cancers requiring treatment at the time of entry to the study, or had other malignancies within 5 years prior to enrollment;
- Participants received surgeries other than diagnostic prostate biopsy within 4 weeks before enrollment;
- Participants with active or known human immunodeficiency virus (HIV) with detectable viral load; active hepatitis B, defined as positive HBV DNA viral load or as defined by relevant guidelines; hepatitis C virus (HCV)...
- Participants with a history of non-compliance to medical regimen or inappropriate for the study, attributed to not meeting the principle of optimal benefit treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, 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 Xiamen, Fujian, China. 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.