Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Rezvilutamide
Drug240mg by mouth once a day for 24 weeks.
Goserelin Microspheres for Injection
Drug3.6mg by intramuscular injection once 4 weeks for 24 weeks.
Docetaxel
Drug70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).
Pamiparib
Drug60mg by mouth twice a day for 20 weeks.
Cisplatin
Drug70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).
Tislelizumab
Drug200 mg by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Queue 1Experimental treatment 3 interventions
Group B: Queue 2Experimental treatment 3 interventions
Group C: Queue 3Experimental treatment 3 interventions
Group D: Queue 4Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
20 weeks2
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
Time frame
24 weeks3
Rate of complete pathologic response (pCR)
The rate of complete pathologic response (pCR) as assessed on prostatectomy specimens following 24 weeks of neoadjuvant therapy
Time frame
24 weeksSecondary outcomes
1
Progression-free survival
Kaplan-Meier curves
Time frame
3 years2
Overall survival
Kaplan-Meier curves
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov