Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT05956639

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

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-07-21

100

Participants Needed

1

Research Sites

236 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features
  • High tumor burden defined by at least 4 bone metastases with one outside pelvis or spine, or visceral metastases excluding lymph nodes
  • Planned to receive or maintain ADT by LHRHa or surgical castration with 6 cycles of docetaxel chemotherapy
  • Adequate organ function including ANC  1.5 � 10^9/L, platelets  100 � 10^9/L, hemoglobin  90 g/L, bilirubin  1.5 � ULN, ALT and AST  2.5 � ULN, BUN and creatinine  1.5 � ULN, and left ventricular ejection fraction  50%
  • Ability to comply with the trial protocol
  • Voluntary informed consent signed
Not Eligible

You will not qualify if you...

  • Prior prostate cancer treatments including ADT, chemotherapy, surgery, radiation, or investigational therapies except limited short-term ADT or palliative treatments with improved adverse events
  • Previous or planned use of second-generation androgen receptor antagonists or investigational testosterone synthesis inhibitors during the study
  • Use of 5-alpha-reductase inhibitors, hormonal therapies, corticosteroids (except temporary allergic use), or herbal anti-prostate cancer medicines within 4 weeks prior to study start
  • Participation in other clinical trials with investigational treatments
  • Confirmed brain tumor lesions
  • Planned to receive other anticancer treatments during the trial
  • Known allergy to apalutamide, ADT, or chemotherapy components
  • Conditions affecting swallowing or drug absorption
  • History of seizures or seizure-inducing conditions within 12 months
  • Active serious cardiac diseases within 6 months
  • Other cancers within 5 years except in situ or slow progressing malignancies
  • Active hepatitis B or C infection with high viral load
  • Immunodeficiency or organ transplantation
  • Unwillingness to use effective contraception during and 30 days after treatment
  • Conditions posing serious safety risks or affecting ability to complete study such as severe uncontrolled hypertension, diabetes, neurological or psychiatric diseases

AI-Screening

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Trial Site Locations

Total: 1 location

1

Urology dpt, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

S

Shangqian Wang, M.D.,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

2

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