Using apalutamide and 89Sr to treat prostate cancer with bone metastases
Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases
This study is testing if a combination of apalutamide and 89Sr can help men with prostate cancer that has spread to the bones live longer without their cancer getting worse before surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05740488 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of apalutamide combined with 89Sr as a neoadjuvant therapy for patients with prostate cancer that has up to 10 bone metastases. The primary goal is to assess progression-free survival (PFS), while secondary goals include measuring pathological complete response (pCR), radiographic PFS (rPFS), prostate-specific antigen (PSA) response, pain levels, and the number and extent of bone metastases. Participants will undergo laparoscopic radical prostatectomy and pelvic lymphadenectomy, along with preoperative and postoperative endocrine therapy. The study aims to provide insights into a potentially effective treatment regimen for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include men diagnosed with prostate cancer who have confirmed bone metastases of 10 or fewer and are eligible for surgery.
Not a fit: Patients with other organ metastases, severe comorbidities, or those who have had prior treatments for other tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with prostate cancer and limited bone metastases.
How similar studies have performed: While there is ongoing research in this area, the combination of apalutamide and 89Sr as neoadjuvant therapy for this specific condition is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Prostate cancer confirmed by pathological findings; 2. Bone metastasis confirmed by bone scan, the number of bone metastases ≤10 3. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy; 4. ECOG score of 0 - 1 5. Agreement to undergo preoperative and postoperative endocrine therapy and 89Sr radionuclide therapy; 6. Voluntary signing of an ICF for the clinical trial Exclusion Criteria: 1. Any other tumor disease requiring treatment; 2. Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis; 3. A history of epilepsy or any condition that may lead to seizures; 4. Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases
Where this trial is running
Guangzhou, Guangdong
- zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Zhang Yiming
- Email: 359281481@qq.com
- Phone: 020-62782726
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.