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A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

ConditionPSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC). The efficacy of HRS-4357 versus novel androgen receptor pathway inhibitors (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) will be evaluated based on radiographic progression-free survival (rPFS) assessed by the BIRC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be willing to participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing;

Male, aged ≥ 18 years;

ECOG performance status score of 0-1;

Expected survival time of no less than 6 months;

Disqualifiers

Any radionuclide therapy or hemi-body radiotherapy within 6 months.

Any PSMA-targeted radiopharmaceutical therapy.

Surgery, radiotherapy, or any local therapy within 4 weeks.

Any other investigational drug intervention within 4 weeks.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-4357 injection

    Drug

    HRS-4357 injection are administered each time, with dosing for 4 to 6 cycles

  • Enzalutamide；Abiraterone

    Drug

    ARPI (investigator's choice of any of the following agents, with the requirement that the agent has not been used previously): * Enzalutamide 160 mg orally once daily (qd) * Abiraterone 1000 mg orally once daily (qd) + Prednisone 5 mg orally twice daily (bid)

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: HRS-4357 injectionExperimental treatment 1 intervention
Group B: Enzalutamide Soft Capsules / Abiraterone Acetate Tablets+ Prednisone Acetate TabletsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

radiographic progression-free survival (rPFS) assessed by the BIRC.

Time frame
From Baseline to primary completion date, about 24 months

Secondary outcomes

1

OS

Time frame
From Baseline to primary completion date, about 24 months
2

rPFS（Investigator-Assessed）

Time frame
From Baseline to primary completion date, about 24 months
3

ORR （Investigator-Assessed and BIRC-Assessed）

Time frame
From Baseline to primary completion date, about 24 months
4

DCR（Investigator-Assessed and BIRC-Assessed）

Time frame
From Baseline to primary completion date, about 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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