AzTrials
AzTrials

Metastatic Hormone-Sensitive Prostate CancerPhase 2RASTOMNCT06134271

Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer

A Phase 2 study testing Rezvilutamide, Rezvilutamide plus abiraterone and Continue previous treatment in people with Metastatic Hormone-Sensitive Prostate Cancer, run by Jianbin Bi.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This multicenter, prospective, cohort study enrolled patients with metastatic hormone-sensitive prostate cancer who had been treated with other novel endocrine or systemic regimens (excluding patients treated with pre-order chemotherapy alone or bicalutamide); To observe the efficacy and safety of rezvilutamide alone… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Rezvilutamide, Rezvilutamide plus abiraterone and Continue previous treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
No sites listed yet
Study dates
15 Nov 2023to 30 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years; male;
  • Patients with pathological detection of prostate cancer and clinical diagnosis of metastatic hormone-sensitive patients with bone scanning, electronic computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET-CT) and other imaging examinations;
  • Patients with mHSPC are allowed to use other novel endocrine or systemic regimens in the pre-order (excluding those treated with chemotherapy alone or bicalutamide), castration with an ongoing gonadotropin-releasing hormone analogue (GnRHa) (drug castration), or prior bilateral orchiectomy (surgical castration); Participants who did not undergo bilateral orchiectomy had to maintain effective pharmacological castration throughout the study period;
  • PSA progression at enrollment: for patients who respond to initial therapy, PSA progression is determined if serum PSA exceeds 25% of the minimum PSA during treatment and > 0.4 ng/mL in absolute terms, and after repeated confirmation 3 weeks after the elevation is found; for patients with persistent PSA elevation after initial treatment, PSA progression is determined when the PSA elevation exceeds 25% of the baseline value and the absolute value is>0.4 ng/mL at 12 weeks of treatment;
  • The Eastern Cooperative Oncology Group（ECOG）PS of 0 or1;
  • The main organ indicators such as blood routine, coagulation function, liver and kidney function, and heart function are normal:
Show all 13Show fewer
  • ANC≥1.5×109/L；
  • PLT≥100×109/L
  • Hb≥90g/L；
  • TBIL≤1.5×ULN；
  • ALT and AST≤2.5×ULN；
  • BUN（or UREC）和Cr≤1.5×ULN；
  • LVEF≥50%； Volunteer to participate in this clinical trial, understand the research procedure, and have signed an informed consent form

Who cannot join

  • Failure to sign an informed consent form;
  • Patients with allergic reactions to the pharmaceutical ingredients or excipients used in the study;
  • Patients with difficulty swallowing or poor digestion and absorption function；
  • Patients with severe liver function impairment (Child Pugh C grade)；
  • Confirmed by imaging, there is a brain tumor lesion; Having a history of epilepsy, or having a disease that can trigger seizures within the 12 months prior to C1D1 (including a history of transient ischemic attacks, stroke, traumatic brain injury with consciousness disorders requiring hospitalization);
  • Active heart disease within the first 6 months of C1D1, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medication;
Show all 11Show fewer
  • Suffering from any other malignant tumor within the first 5 years of C1D1 (excluding fully remitted in situ cancer and malignant tumors that have been determined by the researchers to progress slowly);
  • Have a history of immunodeficiency (including HIV testing positive, other acquired or congenital immunodeficiency diseases) or a history of organ transplantation;
  • Subjects who are unwilling to take effective contraceptive measures during the entire study treatment period and within 30 days after the last administration;
  • According to the judgment of the investigator, there are concomitant diseases (such as poorly controlled hypertension, serious diabetes, neurological or mental diseases, etc.) or any other conditions that seriously endanger the safety of patients, may confuse the research results, or affect the completion of the study by the subjects;
  • Patients participating in other clinical trial studies; After evaluation by the researcher, any other circumstances deemed unsuitable for participation in this study.

Trial locations and contacts

No sites are listed yet.

Jianbin Bi contact

86+ 13998227296

jianbinbi@cmu.edu.cn

About this study

Official title: A Multicenter, Prospective, Cohort Study on the Treatment of Metastatic Hormone-sensitive Prostate Cancer Patients Who Have Progressed After Pre-treatment With Rezvilutamide Combined With Abiraterone

This multicenter, prospective, cohort study enrolled patients with metastatic hormone-sensitive prostate cancer who had been treated with other novel endocrine or systemic regimens (excluding patients treated with pre-order chemotherapy alone or bicalutamide); To observe the efficacy and safety of rezvilutamide alone or in combination with abiraterone in hormone-sensitive prostate cancer patients with PSA progression following prior sequence therapy.

Read the detailed description

This is a multicenter, prospective, cohort study to observe the efficacy and safety of rezvilutamide alone or in combination with abiraterone in patients with hormone-sensitive prostate cancer who have progressed PSA after prior sequencing therapy. Other novel endocrine or systemic regimens were used in these patients (excluding patients treated with pre-order chemotherapy alone or bicalutamide); and received ongoing gonadotropin-releasing hormone analogue (GnRHa) castration therapy (drug castration) or prior bilateral orchiectomy (surgical castration) over the course of the study; Participants who did not undergo bilateral orchiectomy had to maintain effective pharmacological castration throughout the study period.

This study included three cohorts of 160 patients with progressive metastatic hormone-sensitive prostate cancer. 56 patients were included in cohort 1, 56 patients in cohort 2 and 28 patients in cohort 3. Patients in cohort 1 were treated with rezvilutamide, 240 mg/day; Patients in cohort 2 received rezvilutamide at 240 mg/day in combination with abiraterone and hormonal therapy; Patients in cohort 3 maintained promiscuous therapy until disease progression or uncontrolled toxicity. According to PCWG3, the primary endpoint is Time to CRPC. Secondary endpoints included OS, rPFS, time to SEE, liver function assessment, and safety of NCI-TCAE 5.0.

Being tested
Rezvilutamide, Rezvilutamide plus abiraterone, Continue previous treatment
Keywords
prostate cancer, rezvilutamide, abiraterone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RezvilutamideDrug

    Rezvilutamide 240mg qd

  • Rezvilutamide plus abirateroneDrug

    Rezvilutamide 240mg qd plus abiraterone 1000mg + prednisone 5 mg qd

  • Continue previous treatmentDrug

    Continue using the previous treatment regimen for treatment.

Study groups in NCT06134271
Study groupRoleWhat they receive
Rezvilutamide cohortExperimentalRezvilutamide 240 mg orally once a day. Patients should also receive androgen deprivation therapy, which includes both gonadotropin releasing hormone analogue (GnRHa) castration treatment or bilateral orchiectomy.
Receives: Drug: Rezvilutamide
Rezvilutamide plus abiraterone cohortExperimentalRezvilutamide 240 mg orally once a day. Simultaneously, take orally 1000 mg of Abiraterone tablets and 5 mg of prednisone once a day. Patients should also receive androgen deprivation therapy simultaneously, that is, they should also receive gonadotropin releasing hormone analogue (GnRHa) castration treatment or have undergone bilateral orchiectomy.
Receives: Drug: Rezvilutamide plus abiraterone
Continue previous treatment cohortExperimentalContinue using the previous treatment regimen for treatment.
Receives: Drug: Continue previous treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to castration-resistant prostate cancer (CRPC)

    The time reach CRPC is defined as the occurrence of the following events, whichever occurs first, serum PSA progression: PSA value>2 ng/ml, interval of 1 week, consecutive 2 times, increase>50% from baseline, serum testosterone at castrated level (<50 ng/dL or 1.7 nmol/L) or soft tissue, visceral imaging progression or bone injury (following the recommendations of Prostate Cancer Clinical Trial Working Group 3 [PCWG3]); Imaging progression of soft tissue/visceral lesions based on magnetic resonance imaging (MRI)/computed tomography (CT) performed by researchers on the chest, abdomen, and pelvis (based on RECIST 1.1).

    Measured: From the first day of patient enrollment until the time reach CRPC, the duration of the assessment should not exceed 24 months.

Secondary outcomes (5)

  1. Overall survival (OS)

    Overall survival is defined as the time from the first day of enrollment to the patient's death due to any cause.

    Measured: From the first day of patient enrollment to all-cause mortality, the duration of the assessment should not exceed 24 months.

  2. Radiographic Progression-free survival (rPFS)

    The radiographic progression free survival is defined as the time from the first day of patient enrollment to imaging progression or death. Imaging progress includes progress under bone scanning, where at least 2 new lesions are discovered under bone scanning, or measurable soft tissue lesions are detected under computed tomography (CT) or magnetic resonance imaging (MRI) (based on the definition of the Solid Tumor Response Evaluation Standard (RECIST) version 1.1). According to RECIST 1.1 guidelines, progression requires a 20% increase in the sum of all target lesion diameters, and an absolute minimum sum increase of 5 millimeters (mm) compared to the sum of the lowest values.

    Measured: From the first day of patient enrollment to the time reach radiographic progression, the duration of the assessment should not exceed 24 months.

  3. Time to first Symptomatic Skeletal Event (SSE)

    Symptomatic Skeletal Event (SSE) is defined as the occurrence of the following events, including fractures, spinal cord compression, bone specific radiotherapy or surgery, and death from any cause, whichever occurs first.radiotherapy or surgery for bones, death for all cause, whichever occurs first.

    Measured: From the first day of patient enrollment to the occurrence of the SSE, the duration of the assessment should not exceed 24 months.

  4. Liver function assessment

    Liver function will be assessed once every 2 weeks in the first three cycles, once every 4 weeks in the continues treatment.

    Measured: From the first day of patient enrollment to the end of treatment, the evaluation duration should not exceed 24 months

  5. Safety profile

    Any adverse events were recorded starting from the first administration of riviramide or the combination of riviramide and abiolone until the end of the safety follow-up period.Among them, liver function assessment is conducted in the first 3 cycles, once every 2 weeks; Subsequent treatment should be conducted once every 4 weeks.

    Measured: From the first day of patient enrollment to the end of treatment, the evaluation duration should not exceed 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start15 Nov 2023 (estimated)
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134271
Sponsor's protocol ID
FirstHCMU-JBi-RASTOM
Acronym
RASTOM
Status last verified
Nov 2023
First submitted
29 Oct 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rezvilutamide, Rezvilutamide plus abiraterone and Continue previous treatment in people with Metastatic Hormone-Sensitive Prostate Cancer, run by Jianbin Bi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianbin Bi (86+ 13998227296, jianbinbi@cmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to castration-resistant prostate cancer (CRPC) (time frame: From the first day of patient enrollment until the time reach CRPC, the duration of the assessment should not exceed 24 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06134271.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in