Locally Advanced Prostate CancerPhase 2SEGNONCT06387056
Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)
A Phase 2 study testing Rezvilutamide, Goserelin Microspheres for Injection and Docetaxel in people with Locally Advanced Prostate Cancer and Oligometastatic Prostate Cancer, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Locally Advanced Prostate Cancer, Oligometastatic Prostate Cancer
- What is being tested?
- Rezvilutamide, Goserelin Microspheres for Injection and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Apr 2029
- Phase
- Phase 2
- 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
- Males ≥ 18 years of age;
- Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate;
- Imaging examination (defined by multiparametric magnetic resonance imaging, radionuclide bone scan and PSMA PET/CT (prostate-specific membrane antigen positron emission tomography/computed tomography) confirmed locally advanced (identified as cT3b to cT4, N0 to N1, M0) and oligometastatic (identified as no visceral metastasis and ≤5 bone metastases) prostate cancer. Participants are considered tolerable to radical prostatectomy (RP) and pelvic lymph node dissection (PLND) after neoadjuvant therapy (NT). Participants must consent to RP and PLND after NT when defined as tolerable for RP and PLND at registration and prior to enrolment in the trial;
- Histologically confirmed adenocarcinoma of the prostate without pathologic evidence of small cell and neuroendocrine differentiation at the time of initial diagnosis;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and a life expectancy of ≥ 3 years;
- Participants must have adequate end-organ function to tolerate NT and subsequent RP+PLND and all laboratory tests must be performed within 4 weeks prior to registration into master protocol. Including the following indicators: hemoglobin (Hb) ≥85g/L; White blood cell count (WBC) ≥3.0×109 /L; Platelet (PLT) ≥ 75×109 /L; Liver function: Total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5× upper limit of normal value (ULN); Albumin (ALB) ≥25g/L; Renal function: glomerular filtration rate (GFR) ≥ 60ml/min;
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- Participants must consent to genetic testing at registration and prior to enrolment in the trial;
- No prior systemic or localized treatment for prostate cancer. Up to 28 days of LHRHa, non-steroidal anti-androgen (NSAA) and novel hormone therapy (rezvilutamide) are allowable prior to treatment;
- Participants must have the ability to swallow oral medication and follow the study procedure;
- Participants must consent to use reliable contraceptive methods (such as condoms) and not to donate sperm throughout the study period and for 3 months after the last NT administration;
- Participants must have no contraindications to any of the relevant drug treatments in the study.
Who cannot join
- Participants with a history of hypersensitivity to any of the relevant drugs involved in this study;
- Participants received more than 28 days of LHRHa, non-steroidal anti-androgen (NSAA) and novel hormone therapy (rezvilutamide) prior to registration, or enrolled in any other clinical studies for therapeutic purposes within 28 days prior to enrollment, or received any approved anticancer therapy within 28 days prior to enrollment;
- Participants received local treatments of primary or metastatic lesions prior to enrollment;
- Participants received bilateral orchiectomy prior to enrollment;
- Hypogonadism or severe androgen deficiency as defined by screening serum testosterone more than 50 ng/dL below the normal range for the institution;
- Participants with a history of brain metastases or epilepsy;
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- Participants with severe cardiovascular disease, including: myocardial infarction or thrombosis in the previous 6 months; known unstable angina; history of documented congestive heart failure (New York Heart Association functional classification III-IV; QT interval > 480 ms; uncontrolled hypertension defined as resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg;
- Participants with clinically significant digestive tract abnormalities that may affect the process of drug intake, transport, or absorption (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc., or total gastrectomy);
- Participants with other clinically significant co-morbidities evaluated by the investigator, including uncontrolled lung disease, active central nervous system disease, active or uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, or any other disease that may make the participant inappropriate for enrollment or RT + PLND after NT;
- Participants with other known active cancers requiring treatment at the time of entry to the study, or had other malignancies within 5 years prior to enrollment;
- Participants received surgeries other than diagnostic prostate biopsy within 4 weeks before enrollment;
- Participants with active or known human immunodeficiency virus (HIV) with detectable viral load; active hepatitis B, defined as positive HBV DNA viral load or as defined by relevant guidelines; hepatitis C virus (HCV), except for those have been treated and have an undetectable viral load;
- Participants with a history of non-compliance to medical regimen or inappropriate for the study, attributed to not meeting the principle of optimal benefit treatment.
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
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Kaiyan Zhang, M.D., +865922139714, zkyken@163.com
Haichao Huang, M.D., +865922139493, hhc_pku@163.com
About this study
Official title: An Exploratory Study of the Safety and Efficacy of Genomic Biomarker-guided Neoadjuvant Therapy for Locally Advanced and Oligometastatic Prostate Cancer (SEGNO)
To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer.
Read the detailed description
According to the results of the genomic profile, patients will be assigned to 4 neoadjuvant therapy (NT) groups (Queue 1 to 4): Queue 1: No targetable actionable aberration; Queue 2: Homologous recombination repair (HRR) alterations (BRCA1/2); Queue 3: Homologous recombination repair alterations (except BRCA1/2 and CDK12); Queue 4: MSI-H/dMMR, TMB≥10mut/Mb or CDK12 alterations without other HRR alterations. A following PSMA PETCT for evaluating the efficacy of NT and radical prostatectomy (RP) plus pelvic lymph node dissection (PLND) will be perform. The histopathological and survival data after RP plus PLND will also be evaluated.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RezvilutamideDrug
240mg by mouth once a day for 24 weeks.
Goserelin Microspheres for InjectionDrug
3.6mg by intramuscular injection once 4 weeks for 24 weeks.
DocetaxelDrug
70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).
PamiparibDrug
60mg by mouth twice a day for 20 weeks.
CisplatinDrug
70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).
TislelizumabDrug
200 mg by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Queue 1 | Experimental | Rezvilutamide plus ADT plus docetaxel. Receives: Drug: Rezvilutamide; Drug: Goserelin Microspheres for Injection; Drug: Docetaxel |
| Queue 2 | Experimental | Rezvilutamide plus ADT plus pamiparib. Receives: Drug: Rezvilutamide; Drug: Goserelin Microspheres for Injection; Drug: Pamiparib |
| Queue 3 | Experimental | Rezvilutamide plus ADT plus cisplatin. Receives: Drug: Rezvilutamide; Drug: Goserelin Microspheres for Injection; Drug: Cisplatin |
| Queue 4 | Experimental | Rezvilutamide plus ADT plus tislelizumab. Receives: Drug: Rezvilutamide; Drug: Goserelin Microspheres for Injection; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical complete response (cCR)
The rate of clinical complete response (cCR) as assessed using PSMA PET/CT and mp-MRI following 20 weeks of neoadjuvant therapy
Measured: 20 weeks
Rate of pathological minimal residual disease (pMRD)
The rate of pathological minimal residual disease (defined as residual tumour 5 mm or less) as assessed on prostatectomy specimens following 24 weeks of neoadjuvant therapy
Measured: 24 weeks
Rate of complete pathologic response (pCR)
The rate of complete pathologic response (pCR) as assessed on prostatectomy specimens following 24 weeks of neoadjuvant therapy
Measured: 24 weeks
Secondary outcomes (2)
Progression-free survival
Kaplan-Meier curves
Measured: 3 years
Overall survival
Kaplan-Meier curves
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaiyan Zhang, M.D., Principal investigator, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387056
- Sponsor's protocol ID
- XMYY-2024KY040
- Acronym
- SEGNO
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang H, Wang T, Li W, Wu Z, Wang X, Xing J, Chen B, Zhang K. Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial. BMC Cancer. 2025 Mar 10;25(1):432. doi: 10.1186/s12885-025-13826-5.
PubMed 40065286
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Safety and Efficacy of Genomic Biomarker-guided Neoadjuvant Therapy for Locally Advanced and Oligometastatic Prostate Cancer (SEGNO)
- ClinicalTrials.gov ID
- NCT06387056
- Acronym / sponsor ID
- SEGNO / XMYY-2024KY040
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 26 Apr 2024 (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.
To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer.
Detailed description
According to the results of the genomic profile, patients will be assigned to 4 neoadjuvant therapy (NT) groups (Queue 1 to 4): Queue 1: No targetable actionable aberration; Queue 2: Homologous recombination repair (HRR) alterations (BRCA1/2); Queue 3: Homologous recombination repair alterations (except BRCA1/2 and CDK12); Queue 4: MSI-H/dMMR, TMB≥10mut/Mb or CDK12 alterations without other HRR alterations. A following PSMA PETCT for evaluating the efficacy of NT and radical prostatectomy (RP) plus pelvic lymph node dissection (PLND) will be perform. The histopathological and survival data after RP plus PLND will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Queue 1 | Experimental | Drug: Rezvilutamide, Drug: Goserelin Microspheres for Injection, Drug: DocetaxelRezvilutamide plus ADT plus docetaxel. |
| Queue 2 | Experimental | Drug: Rezvilutamide, Drug: Goserelin Microspheres for Injection, Drug: PamiparibRezvilutamide plus ADT plus pamiparib. |
| Queue 3 | Experimental | Drug: Rezvilutamide, Drug: Goserelin Microspheres for Injection, Drug: CisplatinRezvilutamide plus ADT plus cisplatin. |
| Queue 4 | Experimental | Drug: Rezvilutamide, Drug: Goserelin Microspheres for Injection, Drug: TislelizumabRezvilutamide plus ADT plus tislelizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males ≥ 18 years of age;
- Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate;
- Imaging examination (defined by multiparametric magnetic resonance imaging, radionuclide bone scan and PSMA PET/CT (prostate-specific membrane antigen positron emission tomography/computed tomography) confirmed locally advanced (identified as cT3b to cT4, N0 to N1, M0) and oligometastatic (identified as no visceral metastasis and ≤5 bone metastases) prostate cancer. Participants are considered tolerable to radical prostatectomy (RP) and pelvic lymph node dissection (PLND) after neoadjuvant therapy (NT). Participants must consent to RP and PLND after NT when defined as tolerable for RP and PLND at registration and prior to enrolment in the trial;
- Histologically confirmed adenocarcinoma of the prostate without pathologic evidence of small cell and neuroendocrine differentiation at the time of initial diagnosis;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and a life expectancy of ≥ 3 years;
Key exclusion criteria (13 listed)
- Participants with a history of hypersensitivity to any of the relevant drugs involved in this study;
- Participants received more than 28 days of LHRHa, non-steroidal anti-androgen (NSAA) and novel hormone therapy (rezvilutamide) prior to registration, or enrolled in any other clinical studies for therapeutic purposes within 28 days prior to enrollment, or received any approved anticancer therapy within 28 days prior to enrollment;
- Participants received local treatments of primary or metastatic lesions prior to enrollment;
- Participants received bilateral orchiectomy prior to enrollment;
- Hypogonadism or severe androgen deficiency as defined by screening serum testosterone more than 50 ng/dL below the normal range for the institution;
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 |
|---|---|---|
| Rezvilutamide240mg by mouth once a day for 24 weeks. | Drug | Queue 1, Queue 2, Queue 3, Queue 4 |
| Goserelin Microspheres for Injection3.6mg by intramuscular injection once 4 weeks for 24 weeks. | Drug | Queue 1, Queue 2, Queue 3, Queue 4 |
| Docetaxel70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks). | Drug | Queue 1 |
| Pamiparib60mg by mouth twice a day for 20 weeks. | Drug | Queue 2 |
| Cisplatin70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks). | Drug | Queue 3 |
| Tislelizumab200 mg by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks). | Drug | Queue 4 |
Primary outcome
Rate of clinical complete response (cCR)
Time frame: 20 weeks
The rate of clinical complete response (cCR) as assessed using PSMA PET/CT and mp-MRI following 20 weeks of neoadjuvant therapy
Rate of pathological minimal residual disease (pMRD)
Time frame: 24 weeks
The rate of pathological minimal residual disease (defined as residual tumour 5 mm or less) as assessed on prostatectomy specimens following 24 weeks of neoadjuvant therapy
Rate of complete pathologic response (pCR)
Time frame: 24 weeks
The rate of complete pathologic response (pCR) as assessed on prostatectomy specimens following 24 weeks of neoadjuvant therapy
2 secondary outcomes
Progression-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
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 26 Apr 2024.
- Derived from this study: PubMed 40065286Huang H, Wang T, Li W, Wu Z, Wang X, Xing J, Chen B, Zhang K. Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial. BMC Cancer. 2025 Mar 10;25(1):432. doi: 10.1186/s12885-025-13826-5.
- 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.
Kaiyan Zhang, M.D. principal investigator
The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rezvilutamide, Goserelin Microspheres for Injection and Docetaxel in people with Locally Advanced Prostate Cancer and Oligometastatic Prostate Cancer, run by The First Affiliated Hospital of Xiamen 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 11 inclusion and 13 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 26 Apr 2024. 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 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?
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 Kaiyan Zhang, M.D. (+865922139714, zkyken@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinical complete response (cCR) (time frame: 20 weeks). The study lists 3 primary outcomes in all. 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 NCT06387056, which also lists 1 linked publication.
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 26 Apr 2024.