Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Phase 3NCT05956639
Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC
A Phase 3 study testing 6-month course of antiandrogen drugs and Long-term course of antiandrogen drugs in people with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- What is being tested?
- 6-month course of antiandrogen drugs and Long-term course of antiandrogen drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2023to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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.
- 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:
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- 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.
- Voluntarily participate in the clinical trial, understand the study procedures, and have signed the informed consent form.
Who cannot join
- 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.
- 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:
- 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride).
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- 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.
- Active HBV or HCV infection (HBV viral load ≥ 10,000 copies/mL, HCV viral load ≥ 1,000 copies/mL).
- History of immunodeficiency (including positive HIV test) or organ transplantation.
- Unwillingness to use effective contraception during the entire study treatment period and for 30 days after the last dose.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Urology dpt, First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Shangqian Wang, M.D.,PhD., 68303186, wsq5501@126.com
Lixin Hua, M.D.
About this study
Official title: A Multi-center, Randomized, Open-label Clinical Trial Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in High Tumor Burden mHSPC
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).
Read more
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.
Read the detailed description
Primary Study Endpoints:
Radiographic progression-free survival (rPFS)
Secondary Study Endpoints:
Time to prostate-specific antigen (PSA) progression Time to next bone-related event (including fractures, spinal cord compression, radiation therapy, or surgery targeting the bones) Time to initiation of subsequent anti-prostate cancer treatment Objective response rate (ORR) Quality of life assessment scores
- Being tested
- 6-month course of antiandrogen drugs, Long-term course of antiandrogen drugs
- Keywords
- Triple treatment regimen, mHPSC, Rezvilutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-month course of antiandrogen drugsDrug
Also called Rezvilutamide
6-month course of Rezvilutamide and ADT + chemotherapy
Long-term course of antiandrogen drugsDrug
Also called Rezvilutamide
Long-term course of Rezvilutamide and ADT + chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 6-month course of Rezvilutamide | Experimental | 6-month course of Rezvilutamide with ADT and chemotherapy Receives: Drug: 6-month course of antiandrogen drugs |
| Long-term course of Rezvilutamide | Active comparator | Long-term course of Rezvilutamide with ADT and chemotherapy Receives: Drug: Long-term course of antiandrogen drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
rPFS
Radiographic progression-free survival
Measured: 36 months
Secondary outcomes (5)
Time to prostate-specific antigen (PSA) progression
Time to PSA doubling on ADT + Rezvilutamide + Chemo
Measured: 36 months
Time to next bone-related event
including fractures, spinal cord compression, radiation therapy, or surgery targeting the bones
Measured: 36 months
Time to initiation of subsequent anti-prostate cancer treatment
Bone related treatment; Radiation therapy
Measured: through study completion, an average of 3 year
Objective response rate (ORR)
PSA response, tumor burden shrink on radiographic reports
Measured: 36 months
Quality of life assessment scores
Quality of life form with higher score indicating a better life experience under cancer condition
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start20 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Lixin, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Lixxin Hua, Principal investigator, Urology Dpt, First Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956639
- Sponsor's protocol ID
- 2023-SR-258
- Status last verified
- Jul 2023
- First submitted
- 20 Jun 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label Clinical Trial Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in High Tumor Burden mHSPC
- ClinicalTrials.gov ID
- NCT05956639
- Acronym / sponsor ID
- 2023-SR-258
- Keywords
- Triple treatment regimen, mHPSC, Rezvilutamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Study Endpoints:
Radiographic progression-free survival (rPFS)
Secondary Study Endpoints:
Time to prostate-specific antigen (PSA) progression Time to next bone-related event (including fractures, spinal cord compression, radiation therapy, or surgery targeting the bones) Time to initiation of subsequent anti-prostate cancer treatment Objective response rate (ORR) Quality of life assessment scores
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-month course of Rezvilutamide | Experimental | Drug: 6-month course of antiandrogen drugs6-month course of Rezvilutamide with ADT and chemotherapy |
| Long-term course of Rezvilutamide | Active comparator | Drug: Long-term course of antiandrogen drugsLong-term course of Rezvilutamide with ADT and chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
Key exclusion criteria (20 listed)
- 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:
- 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:
- Confirmed brain tumor lesions on imaging.
- Planned to receive any other anticancer treatment during the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-month course of antiandrogen drugsAlso: Rezvilutamide6-month course of Rezvilutamide and ADT + chemotherapy | Drug | 6-month course of Rezvilutamide |
| Long-term course of antiandrogen drugsAlso: RezvilutamideLong-term course of Rezvilutamide and ADT + chemotherapy | Drug | Long-term course of Rezvilutamide |
Primary outcome
rPFS
Time frame: 36 months
Radiographic progression-free survival
5 secondary outcomes
Time to prostate-specific antigen (PSA) progression
Time frame: 36 months
Time to next bone-related event
Time frame: 36 months
Time to initiation of subsequent anti-prostate cancer treatment
Time frame: through study completion, an average of 3 year
Objective response rate (ORR)
Time frame: 36 months
Quality of life assessment scores
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lixxin Hua principal investigator
Urology Dpt, First Affiliated Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 6-month course of antiandrogen drugs and Long-term course of antiandrogen drugs in people with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 16 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shangqian Wang, M.D.,PhD (68303186 ext. 25, wsq5501@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rPFS (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2023.