Evaluating apalutamide for high-risk prostate cancer treatment before surgery
An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
This study is testing if a new medication called apalutamide can help men with high-risk prostate cancer do better after surgery by reducing the chances of cancer coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04997252 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of apalutamide as a neoadjuvant endocrine therapy for patients with high-risk and oligometastatic prostate cancer. The study aims to improve patient prognosis by reducing the rate of positive surgical margins and recurrence rates while ensuring high safety standards. Participants will undergo laparoscopic radical prostatectomy and pelvic lymphadenectomy, with preoperative and postoperative endocrine therapy as part of the treatment protocol.
Who should consider this trial
Good fit: Ideal candidates are adult males over 18 with confirmed high-risk or oligometastatic prostate cancer who are willing to undergo surgery.
Not a fit: Patients with other active tumor diseases, severe organ dysfunction, or significant metastasis to organs like the liver or brain may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the outcomes for patients with high-risk prostate cancer.
How similar studies have performed: Other studies have shown promising results with neoadjuvant endocrine therapies in prostate cancer, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult males aged above 18 years old, no healthy volunteers included; 2. Prostate cancer confirmed by pathological findings; 3. High risk based on risk assessment, or laboratory tests suggestive of oligometastasis; 4. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy; 5. ECOG score of 0 - 1 6. Agreement to undergo preoperative and postoperative endocrine therapy; 7. 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: 59281481@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.