Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC

NCT05956639 | Recruiting Phase 3

• 1 other identifier: 2023-SR-258
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC). Secondary Objectives: To evaluate and compare the time to prostate-specific antigen (PSA) progression, time to next bone-related event, time to initiation of subsequent anti-prostate cancer treatment, and objective response rate (ORR) between the 6-month and long-term course of Rezvilutamide with androgen deprivation therapy (ADT) plus docetaxel in patients with high tumor burden mHSPC. To assess and compare the incidence of adverse events between the 6-month and long-term course of Rezvilutamide with ADT plus docetaxel in patients with high tumor burden mHSPC. Exploratory Objectives: To observe the circulating tumor cell status at 6 months, 12 months, 18 months, and 24 months in patients with high tumor burden mHSPC receiving the triple therapy regimen.

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Keywords

Triple treatment regimen; mHPSC; Rezvilutamide

Outcome Measures

Primary Outcomes (1)

• rPFS

  Radiographic progression-free survival

  36 months

Secondary Outcomes (5)

• Time to prostate-specific antigen (PSA) progression

  36 months

• Time to next bone-related event

  36 months

• Time to initiation of subsequent anti-prostate cancer treatment

  through study completion, an average of 3 year

• Objective response rate (ORR)

  36 months

• Quality of life assessment scores

  36 months

Study Arms (2)

6-month course of Rezvilutamide

EXPERIMENTAL

6-month course of Rezvilutamide with ADT and chemotherapy

Drug: 6-month course of antiandrogen drugs

Long-term course of Rezvilutamide

ACTIVE COMPARATOR

Long-term course of Rezvilutamide with ADT and chemotherapy

Drug: Long-term course of antiandrogen drugs

Interventions

6-month course of antiandrogen drugs DRUG

6-month course of Rezvilutamide and ADT + chemotherapy

Also known as: Rezvilutamide

6-month course of Rezvilutamide

Long-term course of antiandrogen drugs DRUG

Long-term course of Rezvilutamide and ADT + chemotherapy

Also known as: Rezvilutamide

Long-term course of Rezvilutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, male.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell features.
• 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).
• 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.
• 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%.
• Judged by the investigator to be able to comply with the trial protocol.

You may not qualify if:

• 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.
• 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.
• Received the following treatments within 4 weeks before C1D1:
• 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.
• Confirmed brain tumor lesions on imaging.
• Planned to receive any other anticancer treatment during the trial.
• Known allergy or hypersensitivity to apalutamide, ADT, or chemotherapy components.
• Presence of conditions that impede swallowing, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.
• 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).
• 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.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Urology dpt, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Study Officials

• Lixxin Hua

  Urology Dpt, First Affiliated Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shangqian Wang, M.D.,PhD

CONTACT

68303186; wsq5501@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 21, 2023
• Study Start: June 20, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)