Maximal tumor eradication for patients with oligometastatic prostate cancer
Apatamide Combined With Maximal Tumor Eradication for Oligometastatic Prostate Cancer, A Prospective Randomized Controlled Trial
This study is testing a new combination treatment for men with oligometastatic prostate cancer to see if it can improve their survival and quality of life.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06972511 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a combination treatment involving neoadjuvant apalutamide, androgen deprivation therapy (ADT), radical prostatectomy, extended lymph node dissection, and radiotherapy for patients diagnosed with oligometastatic prostate cancer. The study is designed to refine management strategies for metastatic hormone-sensitive prostate cancer (mHSPC) in China, where early detection is less common. By focusing on a comprehensive treatment approach, the trial seeks to improve survival rates and quality of life for affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are men under 75 years old with oligometastatic prostate cancer who are suitable for surgery and radiotherapy.
Not a fit: Patients with visceral metastasis, serious infections, or those who cannot accept radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with oligometastatic prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar treatment approaches for oligometastatic prostate cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age less than 75 years * EORTC QLQC-30 score 2 * Life expectancy of 10 years * Patients with oligometastatic prostate cancer on clinicopathological assessment * Patients are suitable for radiotherapy and prostatectomy surgery * Patients agree to participate in the study and sign the informed consent form before enrollment Exclusion Criteria: * Tumor related fracture * Cannot accept radiotherapy * Visceral metastasis * Serious infection * Thromboembolism history * Not effectively controlled cardiovascular complications
Where this trial is running
Shanghai
- RenJi hospital, school of Medicine, Shanghai Jiao Tong University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: JiaHua Pan, Doctor
- Email: jiahua.pan@outlook.com
- Phone: +8613916989510
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.