About this trial
To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer.
Eligibility criteria
Qualifiers
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
Treatments tested in this trial
- Rezvilutamide
- Goserelin Microspheres for Injection
- Docetaxel
- Pamiparib
- Cisplatin
- Tislelizumab