Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)
To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer.
| Condition(s) | Locally Advanced Prostate Cancer, Oligometastatic Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer. |
| Who can participate | Inclusion Criteria: * 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). Part |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | The First Affiliated Hospital of Xiamen University |
| Locations | Xiamen, Fujian, China |
| Start date | 2024-04-01 |
| NCT ID | NCT06387056 |
| Official listing | https://clinicaltrials.gov/study/NCT06387056 |