Prostate Cancer (Adenocarcinoma)NCT07444983
Rezvilutamide for High-Risk Prostate Cancer After Surgery
A study testing Rezvilutamide and Leuprorelin in people with Prostate Cancer (Adenocarcinoma), run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Rezvilutamide works to treat high-risk prostate cancer in patients who have recently undergone surgery (radical prostatectomy). It will also learn about the safety of Rezvilutamide. Read more about this study
- Who is it for?
- Ages 18 to 95 years, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Rezvilutamide and Leuprorelin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2026to 11 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for entry into this study:
- Age ≥ 18 years.
- Histologically confirmed adenocarcinoma of the prostate following radical prostatectomy.
- Evaluated by the investigator as requiring pharmacological treatment.
- ECOG Performance Status of 0 or 1.
- Preoperative imaging ruled out metastatic disease.
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- Must meet at least one of the following postoperative high-risk factors:
- Positive surgical margins;
- Pathological stage pT3-pT4;
- Lymph node metastasis;
- Preoperative PSA ≥ 20 ng/ml.
- Unwilling to receive postoperative radiotherapy.
- PSA < 0.1 ng/ml during the screening period.
- Capable of understanding and voluntarily signing the Informed Consent Form (ICF).
Who cannot join
- Patients meeting any of the following criteria will be excluded from the study:
- Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features.
- Known or suspected hypersensitivity to Rezvilutamide or any of its excipients.
- Factors affecting drug administration or absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- History of seizures or presence of conditions predisposing to seizures within 12 months prior to screening (including history of transient ischemic attack, stroke, or traumatic brain injury with loss of consciousness requiring hospitalization).
- Active cardiac disease within 6 months prior to screening, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment.
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- History of other malignancies within 3 years prior to screening (except for completely remitted carcinoma in situ or malignancies judged by the investigator to be slow-progressing).
- Active HBV or HCV infection (HBV DNA ≥ 10^4 copies/mL, HCV RNA ≥ 10^3 copies/mL).
- History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or history of organ transplantation.
- Male subjects with female partners of childbearing potential who refuse surgical sterilization or refuse to use effective contraception during the study period.
- Any other condition which, in the opinion of the investigator, may interfere with the conduct of the study, compromise protocol compliance, or pose an unacceptable risk to the subject.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Urology, Fujian Union Hospital, Fujian Medical University
Fuzhou, Fujian, 350000
Jiabing Zheng, +8613799422519, xhyykjk@163.com
About this study
Official title: An Exploratory Clinical Study of Rezvilutamide as Adjuvant Therapy for High-Risk Patients After Radical Prostatectomy
The goal of this clinical trial is to learn if Rezvilutamide works to treat high-risk prostate cancer in patients who have recently undergone surgery (radical prostatectomy). It will also learn about the safety of Rezvilutamide. The main questions it aims to answer are:
Does Rezvilutamide, when used as an add-on treatment after surgery, lower the risk of the cancer returning (biochemical recurrence) within 3 years? What is the 36-month metastasis-free survival (MFS) rate for patients receiving this treatment? What is the safety profile of Rezvilutamide combined with ADT, specifically regarding the types, grades, and incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs), and rare adverse events? What are the exploratory findings regarding the status of immune cells after using Rezvilutamide?
Read more
Researchers will evaluate the combination of Rezvilutamide and hormone therapy (ADT) to see if it helps keep patients cancer-free.
Participants will:
Take Rezvilutamide: 240 mg once daily, taken orally before or after breakfast. Each cycle is 28 days, for up to 24 cycles. Treatment continues unless biochemical recurrence, disease progression, intolerable toxicity occurs, or the participant withdraws consent, as determined by the investigator.
Receive Androgen Deprivation Therapy (ADT): Leuprorelin 3.75mg via subcutaneous injection, once every 28 days for a total of 12 cycles.
Read the detailed description
[Study Rationale \& Background] High-risk prostate cancer is typically defined by factors including clinical stage (e.g., cT3-4), a Gleason score of 8 or higher, and Prostate-Specific Antigen (PSA) levels greater than 20 ng/mL. Patients meeting these criteria face a significant risk of recurrence after radical prostatectomy (RP). While adjuvant radiotherapy is a standard option, many patients cannot tolerate or choose not to undergo radiation. This study explores an intensive endocrine therapy approach using Rezvilutamide, a potent new-generation oral androgen receptor (AR) inhibitor, combined with standard Androgen Deprivation Therapy (ADT).
[Study Design \& Intervention] This is an exploratory, prospective, single-arm clinical study. After enrollment, participants will receive a combination therapy of standard-dose Rezvilutamide (240 mg once daily, orally) and ADT (Leuprorelin 3.75 mg subcutaneous injection, once every 4 weeks). Each treatment cycle lasts 28 days. After completing 12 cycles of the combination therapy, participants will proceed to monotherapy with standard-dose Rezvilutamide for maintenance. The total duration of treatment will be up to 24 cycles. The primary objective is to evaluate the 3-year biochemical recurrence-free survival (BCRFS) rate.
[Safety \& Exploratory Objectives] Secondary objectives focus on the 36-month metastasis-free survival (MFS) rate and a comprehensive safety profile. This includes monitoring the types, grades, and incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Adverse Events of Special Interest (AESIs). Additionally, the study includes an exploratory analysis of immune cell status to characterize the biological impact of Rezvilutamide on the patient's immune environment during treatment.
[Quality of Life] Patient-reported outcomes and quality of life will be monitored throughout the study using standardized assessment tools, including the FACT-P, EPIC-26, and BPI-SF scales, to ensure a holistic evaluation of the treatment's impact on physical and emotional well-being.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- Rezvilutamide and Leuprorelin
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezvilutamide and LeuprorelinDrug
Combination Phase (Cycles 1-12): Rezvilutamide 240 mg orally once daily, combined with Leuprorelin 3.75 mg via subcutaneous injection every 28 days.
Maintenance Phase (Cycles 13-24): Rezvilutamide 240 mg orally once daily as monotherapy.
Duration: Each cycle is 28 days. The total treatment duration is up to 24 cycles (approximately 2 years). This study specifically focuses on the adjuvant intensive endocrine therapy for high-risk patients following radical prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Rezvilutamide plus ADT (Leuprorelin) | Experimental | Participants will receive Rezvilutamide (240 mg daily) plus ADT (Leuprorelin 3.75mg every 28 days) for 12 cycles, followed by Rezvilutamide monotherapy (240 mg daily) for up to 12 additional cycles. The total treatment duration is up to 24 cycles. Receives: Drug: Rezvilutamide and Leuprorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Biochemical Recurrence-Free Survival (BCRFS) Rate.
Measured: Up to 36 months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start11 Feb 2026 (estimated)
- Primary completion11 Feb 2027 (estimated)
- Study completion11 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mengqiang Li, Principal investigator, Department of Urology, Fujian Union Hospital, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444983
- Sponsor's protocol ID
- 2025KY291
- Status last verified
- Jan 2026
- First submitted
- 24 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Rezvilutamide as Adjuvant Therapy for High-Risk Patients After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07444983
- Acronym / sponsor ID
- 2025KY291
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 11 Feb 2026 (estimated)
- Primary completion
- 11 Feb 2027 (estimated)
- Study completion
- 11 Jul 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Rezvilutamide works to treat high-risk prostate cancer in patients who have recently undergone surgery (radical prostatectomy). It will also learn about the safety of Rezvilutamide. The main questions it aims to answer are:
Does Rezvilutamide, when used as an add-on treatment after surgery, lower the risk of the cancer returning (biochemical recurrence) within 3 years? What is the 36-month metastasis-free survival (MFS) rate for patients receiving this treatment? What is the safety profile of Rezvilutamide combined with ADT, specifically regarding the types, grades, and incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs), and rare adverse events? What are the exploratory findings regarding the status of immune cells after using Rezvilutamide?
Researchers will evaluate the combination of Rezvilutamide and hormone therapy (ADT) to see if it helps keep patients cancer-free.
Participants will:
Take Rezvilutamide: 240 mg once daily, taken orally before or after breakfast. Each cycle is 28 days, for up to 24 cycles. Treatment continues unless biochemical recurrence, disease progression, intolerable toxicity occurs, or the participant withdraws consent, as determined by the investigator.
Receive Androgen Deprivation Therapy (ADT): Leuprorelin 3.75mg via subcutaneous injection, once every 28 days for a total of 12 cycles.
Detailed description
[Study Rationale \& Background] High-risk prostate cancer is typically defined by factors including clinical stage (e.g., cT3-4), a Gleason score of 8 or higher, and Prostate-Specific Antigen (PSA) levels greater than 20 ng/mL. Patients meeting these criteria face a significant risk of recurrence after radical prostatectomy (RP). While adjuvant radiotherapy is a standard option, many patients cannot tolerate or choose not to undergo radiation. This study explores an intensive endocrine therapy approach using Rezvilutamide, a potent new-generation oral androgen receptor (AR) inhibitor, combined with standard Androgen Deprivation Therapy (ADT).
[Study Design \& Intervention] This is an exploratory, prospective, single-arm clinical study. After enrollment, participants will receive a combination therapy of standard-dose Rezvilutamide (240 mg once daily, orally) and ADT (Leuprorelin 3.75 mg subcutaneous injection, once every 4 weeks). Each treatment cycle lasts 28 days. After completing 12 cycles of the combination therapy, participants will proceed to monotherapy with standard-dose Rezvilutamide for maintenance. The total duration of treatment will be up to 24 cycles. The primary objective is to evaluate the 3-year biochemical recurrence-free survival (BCRFS) rate.
[Safety \& Exploratory Objectives] Secondary objectives focus on the 36-month metastasis-free survival (MFS) rate and a comprehensive safety profile. This includes monitoring the types, grades, and incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Adverse Events of Special Interest (AESIs). Additionally, the study includes an exploratory analysis of immune cell status to characterize the biological impact of Rezvilutamide on the patient's immune environment during treatment.
[Quality of Life] Patient-reported outcomes and quality of life will be monitored throughout the study using standardized assessment tools, including the FACT-P, EPIC-26, and BPI-SF scales, to ensure a holistic evaluation of the treatment's impact on physical and emotional well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rezvilutamide plus ADT (Leuprorelin) | Experimental | Drug: Rezvilutamide and LeuprorelinParticipants will receive Rezvilutamide (240 mg daily) plus ADT (Leuprorelin 3.75mg every 28 days) for 12 cycles, followed by Rezvilutamide monotherapy (240 mg daily) for up to 12 additional cycles. The total treatment duration is up to 24 cycles. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must meet all of the following criteria to be eligible for entry into this study:
- Age ≥ 18 years.
- Histologically confirmed adenocarcinoma of the prostate following radical prostatectomy.
- Evaluated by the investigator as requiring pharmacological treatment.
- ECOG Performance Status of 0 or 1.
Key exclusion criteria (11 listed)
- Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features.
- Known or suspected hypersensitivity to Rezvilutamide or any of its excipients.
- Factors affecting drug administration or absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- History of seizures or presence of conditions predisposing to seizures within 12 months prior to screening (including history of transient ischemic attack, stroke, or traumatic brain injury with loss of consciousness requiring hospitalization).
- Active cardiac disease within 6 months prior to screening, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rezvilutamide and LeuprorelinCombination Phase (Cycles 1-12): Rezvilutamide 240 mg orally once daily, combined with Leuprorelin 3.75 mg via subcutaneous injection every 28 days. Maintenance Phase (Cycles 13-24): Rezvilutamide 240 mg orally once daily as monotherapy. Duration: Each cycle is 28 days. The total treatment duration is up to 24 cycles (approximately 2 years). This study specifically focuses on the adjuvant intensive endocrine therapy for high-risk patients following radical prostatectomy. | Drug | Rezvilutamide plus ADT (Leuprorelin) |
Primary outcome
3-year Biochemical Recurrence-Free Survival (BCRFS) Rate.
Time frame: Up to 36 months post-enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mengqiang Li principal investigator
Department of Urology, Fujian Union Hospital, Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rezvilutamide and Leuprorelin in people with Prostate Cancer (Adenocarcinoma), run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiabing Zheng (+8613799422519, xhyykjk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Biochemical Recurrence-Free Survival (BCRFS) Rate. (time frame: Up to 36 months post-enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.