Metastatic Prostate CancerPhase 3NCT05983783
Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
A Phase 3 study testing Docetaxel and Rezvilutamide in people with Metastatic Prostate Cancer and Hormone Sensitive Prostate Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer, Chemotherapy Effect
- What is being tested?
- Docetaxel and Rezvilutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged ≥40 years and ≤80 years.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Metastatic disease.
- Eligible for ADT and Docetaxel.
- Started or not started first-generation androgen deprivation therapy (ADT), but not exceeding 12 weeks before randomization.
- ECOG score of 0 or 1.
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- Laboratory tests meet the following requirements:
- Hematology: neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥9g/dL.
- Renal function: serum creatinine ≤1.5× upper limit of normal (ULN).
- Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN, total bilirubin (TBIL) ≤1.5× ULN.
- Coagulation function: international normalized ratio (INR) <1.5.
- Study subjects: Patients with mHSPC have a confirmed pathology of prostate adenocarcinoma with high tumor burden, which is defined by 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).
Who cannot join
- Patients who meet any of the following criteria are not eligible to participate in this study:
- Prior use of LHRH agonists/antagonists; second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other investigational AR inhibitors; CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
- Received radiation therapy/radiopharmaceutical treatment within 2 weeks before randomization.
- Any of the following conditions within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV).
- Previous malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or superficial bladder cancer not invading the deeper muscle layer (i.e., pTis, pTa, and pT1) and any other cancer in complete remission for at least 5 years before randomization.
- Gastrointestinal diseases or procedures that are expected to significantly interfere with the absorption of study treatment.
- Inability to take oral medication.
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 Prospective Randomized Controlled Study Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the Treatment of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.
Read the detailed description
To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the background of next-genertion of AR inhibitors.
- Being tested
- Docetaxel, Rezvilutamide
- Keywords
- Rezvilutamide, mHPSC, chemotherapy, Androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Rezvilutamide
This is Triple drug regimen for mHSPC
RezvilutamideDrug
Also called ADT
This is doubling drug regimen for mHSPC
| Study group | Role | What they receive |
|---|---|---|
| Rezvilutamide+ADT+Docetaxel | Experimental | Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food.
Docetaxel 6 cycles Receives: Drug: Docetaxel |
| Rezvilutamide+ADT | Active comparator | Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food. Receives: Drug: Rezvilutamide |
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 (2)
prostate-specific antigen (PSA) response rate
percentage of patients with a decreasing PSA following the regimens discussed above
Measured: 36 months
time to castration-resistant prostate cancer (CRPC)
time to PSA progression
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 posted9 Aug 2023
- Study start1 Aug 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 Prostate CancerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT05983783
- Sponsor's protocol ID
- 2023-SR-376
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 9 Aug 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the Treatment of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- ClinicalTrials.gov ID
- NCT05983783
- Acronym / sponsor ID
- 2023-SR-376
- Keywords
- Rezvilutamide, mHPSC, chemotherapy, Androgen deprivation therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Aug 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.
Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.
Detailed description
To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the background of next-genertion of AR inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rezvilutamide+ADT+Docetaxel | Experimental | Drug: DocetaxelRezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food. Docetaxel 6 cycles |
| Rezvilutamide+ADT | Active comparator | Drug: RezvilutamideRezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males aged ≥40 years and ≤80 years.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Metastatic disease.
- Eligible for ADT and Docetaxel.
- Started or not started first-generation androgen deprivation therapy (ADT), but not exceeding 12 weeks before randomization.
Key exclusion criteria (7 listed)
- Patients who meet any of the following criteria are not eligible to participate in this study:
- Prior use of LHRH agonists/antagonists; second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other investigational AR inhibitors; CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
- Received radiation therapy/radiopharmaceutical treatment within 2 weeks before randomization.
- Any of the following conditions within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV).
- Previous malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or superficial bladder cancer not invading the deeper muscle layer (i.e., pTis, pTa, and pT1) and any other cancer in complete remission for at least 5 years before randomization.
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 |
|---|---|---|
| DocetaxelAlso: RezvilutamideThis is Triple drug regimen for mHSPC | Drug | Rezvilutamide+ADT+Docetaxel |
| RezvilutamideAlso: ADTThis is doubling drug regimen for mHSPC | Drug | Rezvilutamide+ADT |
Primary outcome
rPFS
Time frame: 36 months
radiographic Progression-Free Survival
2 secondary outcomes
prostate-specific antigen (PSA) response rate
Time frame: 36 months
time to castration-resistant prostate cancer (CRPC)
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 9 Aug 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 Docetaxel and Rezvilutamide in people with Metastatic Prostate Cancer and Hormone Sensitive Prostate Cancer, 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 14 inclusion and 7 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 9 Aug 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., Ph.D. (+862568303186, 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 9 Aug 2023.