Observational study on focal therapy for prostate cancer in Asia
Prospective Multicenter Asian Observational Study of Oncological and Functional Outcomes After Focal Therapy of Prostate Cancer
This study looks at how well different focal therapy treatments for prostate cancer work and how safe they are for patients in Asia with localized disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | Male |
| Sponsor | Singapore General Hospital Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06491056 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study focuses on patients with prostate cancer undergoing various focal therapy techniques, including cryotherapy, high intensity focused ultrasound (HIFU), irreversible electroporation (IRE), and focal laser ablation. The study aims to gather data on the effectiveness and safety of these partial gland ablation methods in treating prostate adenocarcinoma. Patients will be recruited from multiple centers across Asia, specifically targeting those with localized disease and specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are men diagnosed with prostate adenocarcinoma who meet specific criteria regarding Gleason score, cancer volume, PSA levels, and clinical stage.
Not a fit: Patients with extra-prostatic extension of cancer or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of focal therapies, potentially leading to improved treatment options for prostate cancer patients.
How similar studies have performed: Other studies have explored focal therapies for prostate cancer, showing promising results, but this particular study's multicenter approach in Asia may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Prostate Adenocarcinoma * Maximum Gleason score 4+4 * Maximum cancer volume 1.5 ml (up to 2 lesions) or 3 ml (single lesion) * Maximum Prostate Specific Antigen (PSA) level 15 ng/dl * Maximum clinical stage T2c * American Society of Anesthesiologist Criteria 2 or less Exclusion Criteria: * Extra-prostatic Extension on multi parametric magnetic resonance imaging (mpMRI); capsular contact is permitted
Where this trial is running
Singapore
- Singapore General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Kae Jack Tay, MBBS
- Email: tay.kae.jack@singhealth.com.sg
- Phone: 63214693
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.