Prostate Cancer (Post Prostatectomy)Phase 2ARMORNCT07711314
Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy
A Phase 2 study testing Rezvilutamide Tablets in people with Prostate Cancer (Post Prostatectomy), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Prostate cancer patients with high-risk features who undergo radical prostatectomy (RP) are at a significant risk of biochemical recurrence (BCR) and disease progression. While adjuvant androgen deprivation therapy (ADT) with or without radiotherapy is the current standard of care, long-term ADT is associated with… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy)
- What is being tested?
- Rezvilutamide Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to May 2030
- Phase
- Phase 2
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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age and Diagnosis: Male patients aged ≥ 18 and ≤ 75 years with histologically or cytologically confirmed prostate adenocarcinoma.
- Disease Stage and Surgery: Localized prostate cancer (assessed by conventional imaging such as CT and bone scan), having undergone radical prostatectomy within 12 weeks prior to enrollment.
- Postoperative PSA: Postoperative prostate-specific antigen (PSA) level < 0.1 ng/mL within 8 weeks after surgery.
- Risk Stratification: Postoperative CAPRA-S score ≥ 6, indicating a high risk of recurrence.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate Organ Function: Must meet the following laboratory criteria:
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- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (without blood transfusion or G-CSF within 14 days).
- Hemoglobin (HGB) ≥ 90 g/L. Platelet count (PLT) ≥ 100 × 10^9/L. (3) Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × upper limit of normal (ULN) (without blood product transfusion within 14 days).
- (4)Creatinine clearance rate ≥ 30 mL/min. (5) Total bilirubin (TBIL) ≤ 1.5 × ULN. (6) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Radiotherapy Intention: Patients who are unfit for or refuse to receive radiotherapy.
- Contraception: Patients of reproductive potential must be willing to use highly effective contraceptive methods during the study and for 12 weeks after the last dose of study drug. I
- informed Consent: Capable of understanding and providing written informed consent (ICF) and willing to comply with study requirements and evaluation schedules.
Who cannot join
- Histology: Prostate tissue pathology showing neuroendocrine, small cell, or sarcomatoid features.
- Metastasis: Preoperative conventional imaging (e.g., CT or bone scan) indicating pelvic lymph node metastasis (cN1) or distant metastasis (cM1).
- Prior Therapies: Prior androgen deprivation therapy (ADT) (including medical or surgical castration), focal therapy for prostate cancer, or chemotherapy/radiotherapy for prostate cancer.
- Prior Novel Hormonal Agents: Prior treatment with second-generation anti-androgens (e.g., abiraterone, apalutamide, enzalutamide, darolutamide, etc.). ·Recent Surgery: Major surgery requiring general anesthesia (other than radical prostatectomy) within 28 days prior to the first dose of study drug.
- Other Malignancies: History of or concurrent other malignancies within the past 2 years, except for cured non-melanoma skin cancer and superficial bladder tumors (Ta, non-invasive; Tis, carcinoma in situ; and T1).
- Thromboembolic Events: Arterial or venous thromboembolic events (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism) within the past 6 months, or currently receiving therapeutic anticoagulation with warfarin or heparin.
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- Cardiovascular Conditions: Heart rate-corrected QT interval (QTc) > 500 ms; severe cardiovascular disease (myocardial ischemia or infarction grade ≥ II, uncontrolled arrhythmias, NYHA class III-IV heart failure, or LVEF < 50% on echocardiogram).
- Allergies: Known allergy to any study drug or its excipients.
- Active Infections/Hepatitis: Active viral hepatitis requiring treatment (HBV DNA ≥ 500 IU/mL for HBV carriers; positive HCV RNA for HCV antibody-positive patients); known human immunodeficiency virus (HIV) infection; or any other active infection.
- Autoimmune Diseases: Active autoimmune disease or history of autoimmune disease requiring systemic treatment, known history of allogeneic organ or hematopoietic stem cell transplant, or long-term high-dose use of corticosteroids or other immunomodulators.
- Systemic Diseases: History of interstitial lung disease or uncontrolled systemic diseases (e.g., diabetes, hypertension, acute lung disease).
- Seizures: History of epilepsy or conditions that may induce seizures.
- Substance Abuse/Compliance: Underlying medical conditions, alcohol/drug abuse, or dependence that would interfere with drug administration, results interpretation, or pose a high risk for complications.
- Sperm Donation/Family Planning: Men engaging in sexual activity with women of childbearing potential unwilling to use a condom with spermicide, unwilling to abstain from sperm donation during the study and for at least 3 months after the last dose, or planning to have children during this period.
- Concurrent Trials: Concurrent participation in another therapeutic clinical study
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, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital, Affilitated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu
Jiahui Niu, +86 15651680581, 15651680581@163.com
About this study
Official title: Rezvilutamide Monotherapy as Adjuvant Treatment for Patients With High Recurrence Risk After Radical Prostatectomy: A Prospective, Multicenter, Single-Arm Study
Prostate cancer patients with high-risk features who undergo radical prostatectomy (RP) are at a significant risk of biochemical recurrence (BCR) and disease progression. While adjuvant androgen deprivation therapy (ADT) with or without radiotherapy is the current standard of care, long-term ADT is associated with substantial adverse effects, including metabolic syndrome, cardiovascular disease, and bone density loss, which negatively impact patients' quality of life. There is an unmet clinical need to optimize adjuvant treatment strategies to improve survival outcomes while minimizing treatment-related toxicity for this high-risk population. Rezvilutamide is a novel, potent, second-generation oral androgen receptor (AR) inhibitor. This prospective, multicenter, single-arm clinical trial aims to evaluate the efficacy and safety of rezvilutamide monotherapy as an adjuvant treatment in patients with localized prostate cancer who have a high risk of recurrence following radical prostatectomy. The study plans to enroll 48 male patients (aged 18-75 years) who have completed radical prostatectomy within 12 weeks, have achieved a postoperative prostate-specific antigen (PSA) level of < 0.1 ng/mL within 8 weeks, and possess a high recurrence risk defined by a CAPRA-S score of ≥ 6. Eligible patients will receive rezvilutamide monotherapy at a dose of 240 mg orally once daily for 12 cycles (28 days per cycle, totaling 48 weeks). The primary endpoint of the study is the 2-year biochemical progression-free survival (bPFS) rate. Secondary endpoints include event-free survival rate, 5-year bPFS, 5-year metastasis-free survival (MFS), testosterone recovery rate and time at 2 years, overall safety, and health-related quality of life assessed by the FACT-P and EPIC-26 questionnaires. By exploring this monotherapy approach, the study hopes to provide a new, effective, and better-tolerated adjuvant treatment option that can improve the prognosis of high-risk patients post-prostatectomy.
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Being tested
- Rezvilutamide Tablets
- Keywords
- Rezvilutamide, Radical Prostatectomy, Adjuvant Therapy, Prostate Cancer, High-risk
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezvilutamide TabletsDrug
Patients will receive rezvilutamide monotherapy orally at a dose of 240 mg (three 80 mg tablets) once daily. The medication must be swallowed whole and can be taken with or without food. Treatment is initiated between 4 to 12 weeks following radical prostatectomy and continues for 12 consecutive 28-day cycles (totaling 48 weeks). Unlike standard adjuvant regimens or previous metastatic trials that combine novel hormone agents with traditional androgen deprivation therapy (ADT), this study evaluates rezvilutamide strictly as a single-agent therapy. It specifically targets patients with localized prostate cancer who have achieved a postoperative PSA < 0.1 ng/mL but have a high risk of recurrence (CAPRA-S score ≥ 6). If patients experience ≥ Grade 3 or intolerable toxicity, the dose may be interrupted and subsequently reduced to 160 mg or 80 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Rezvilutamide adjuvant therapy | Experimental | Not described Receives: Drug: Rezvilutamide Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Biochemical Progression-Free Survival (bPFS) Rate
Measured: 2 years from the initiation of study treatment
Secondary outcomes (2)
Event-Free Survival (EFS) Rate
Defined as the proportion of patients who remain free from biochemical progression, evidence of clinical recurrence or metastasis, initiation of any other anti-prostate cancer therapy, or death.
Measured: Up to 5 years.
5-Year Biochemical Progression-Free Survival (bPFS)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jul 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Shengli Oilfield Hospital, The Second Hospital of Anhui Medical University
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711314
- Sponsor's protocol ID
- Pca-Ⅱ-JS-004
- Acronym
- ARMOR
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the future publication, including baseline characteristics, efficacy outcomes, and safety data.