Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC
Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jul 13, 2023
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different treatment durations of a medication called Rezvilutamide, combined with hormone therapy and chemotherapy, for men with a specific type of prostate cancer known as metastatic hormone-sensitive prostate cancer (mHSPC). The main goal is to see if a shorter, 6-month course of treatment is just as effective as a longer, ongoing course in preventing the cancer from getting worse on scans. The trial will also look at how long it takes for certain cancer markers to progress, the occurrence of bone-related issues, and any side effects from the treatments.
To be eligible for this trial, participants must be men aged 18 or older with confirmed prostate cancer that has spread significantly, as shown by imaging tests. They should also be able to tolerate the study procedures and have certain health conditions that meet the trial's requirements. Participants can expect to receive either the shorter or longer treatment while being monitored for their health and cancer progression. The trial is currently recruiting participants, and taking part may help improve future treatments for prostate cancer.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- * Inclusion criteria:
- • 1. Age ≥ 18 years, male.
- • 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- • 3. Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell features.
- • 4. High tumor burden, defined as having at least one of the following conditions: 1) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis or spine). 2) CT/MRI revealing visceral metastatic lesions (excluding lymph nodes).
- • 5. Planned to receive or maintain androgen deprivation therapy (ADT) during the study period, either by continuous LHRHa treatment or previous bilateral orchiectomy (surgical castration), concurrently with 6 cycles of docetaxel chemotherapy.
- 6. Organ function levels must meet the following requirements:
- • Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L.
- • Platelets (PLT) ≥ 100 × 10\^9/L.
- • Hemoglobin (Hb) ≥ 90 g/L.
- • Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN).
- • Alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- • Aspartate aminotransferase (AST) ≤ 2.5 × ULN.
- • Blood urea nitrogen (BUN) (or urea) and creatinine (Cr) ≤ 1.5 × ULN.
- • Left ventricular ejection fraction (LVEF) ≥ 50%.
- • 7. Judged by the investigator to be able to comply with the trial protocol.
- • 8. Voluntarily participate in the clinical trial, understand the study procedures, and have signed the informed consent form.
- Exclusion Criteria:
- 1. Prior treatment with ADT, chemotherapy, surgery, external beam radiation therapy, brachytherapy, radiopharmaceuticals, or investigational local therapies for prostate pain. However, the following cases are allowed for inclusion:
- • Up to 3 months of ADT (medical or surgical castration) with or without antiandrogen therapy prior to Cycle 1 Day 1 (C1D1) without evidence of radiographic disease progression (based on RECIST 1.1 criteria) or clinically significant PSA rise (defined as ≥50% increase from the lowest level after reaching castration levels of serum testosterone) before C1D1.
- • Transurethral prostatectomy or up to one course of palliative radiation therapy or surgery for symptomatic treatment of metastatic disease at least 4 weeks prior to C1D1. All adverse events related to these treatments must have improved to at least Grade 1 (according to NCI-CTCAE v4.03) before starting study treatment.
- • 2. Prior use or planned use of second-generation androgen receptor antagonists (such as enzalutamide, apalutamide, darolutamide), abiraterone acetate, or other investigational drugs inhibiting testosterone synthesis for the treatment of prostate cancer during the study period.
- 3. Received the following treatments within 4 weeks before C1D1:
- • 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride).
- • Estrogens, progestins, androgens, systemic corticosteroids (except for temporary use for allergic purposes).
- • Known herbal medicines with anti-prostate cancer or PSA-lowering effects (e.g., saw palmetto).
- • Participation in other clinical trials involving investigational treatments.
- • 4. Confirmed brain tumor lesions on imaging.
- • 5. Planned to receive any other anticancer treatment during the trial.
- • 6. Known allergy or hypersensitivity to apalutamide, ADT, or chemotherapy components.
- • 7. Presence of conditions that impede swallowing, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.
- • 8. History of seizures or occurrence of conditions that can induce seizures within 12 months before C1D1 (including transient ischemic attack, stroke, traumatic brain injury with altered consciousness requiring hospitalization).
- • 9. Presence of active cardiac diseases within 6 months before C1D1, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medication.
- • 10. Diagnosis of any other malignancy within 5 years before C1D1, except for completely resolved in situ cancer or malignancies with slow progression as determined by the investigator.
- • 11. Active HBV or HCV infection (HBV viral load ≥ 10,000 copies/mL, HCV viral load ≥ 1,000 copies/mL).
- • 12. History of immunodeficiency (including positive HIV test) or organ transplantation.
- • 13. Unwillingness to use effective contraception during the entire study treatment period and for 30 days after the last dose.
- • 14. Judged by the investigator to have conditions that pose a serious risk to patient safety, may confound study results, or may affect the patient's ability to complete the study (such as poorly controlled hypertension, severe diabetes, neurological or psychiatric diseases, etc.), or any other relevant circumstances.
About The First Affiliated Hospital With Nanjing Medical University
The First Affiliated Hospital of Nanjing Medical University is a leading medical institution dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital is committed to implementing rigorous scientific methodologies to evaluate new therapies and treatment approaches. With a multidisciplinary team of experienced healthcare professionals and researchers, the hospital fosters a collaborative environment aimed at enhancing patient outcomes and contributing to the global medical community. Its strategic focus on translational medicine ensures that groundbreaking discoveries are efficiently translated into practical applications for patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nanjing, Jiangsu, China
Patients applied
Trial Officials
Lixxin Hua
Principal Investigator
Urology Dpt, First Affiliated Hospital of Nanjing Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported