Identifying risks in low-risk prostate cancer patients on active surveillance
Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance
NA · Università Vita-Salute San Raffaele · NCT06866041
This study is testing whether advanced imaging and genetic tests can help doctors find out which men with low-risk prostate cancer on active surveillance might be at higher risk of their cancer getting worse.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | Male |
| Sponsor | Università Vita-Salute San Raffaele (other) |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06866041 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients diagnosed with low-risk prostate cancer who are eligible for active surveillance. It aims to identify those at higher risk of disease progression by utilizing advanced imaging techniques, such as PSMA PET scans, and molecular analysis through whole exome sequencing and immunohistochemistry. Participants will undergo a confirmatory biopsy one year after diagnosis to assess the predictive accuracy of a multivariable model that integrates these advanced biomarkers. The goal is to improve risk stratification for better management of prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are men with histologically proven low-risk prostate cancer (ISUP Grade Group 1) who are considering active surveillance.
Not a fit: Patients with high-risk prostate cancer or those who have received prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to identify patients who may need more aggressive treatment sooner, potentially improving outcomes.
How similar studies have performed: Other studies have shown promise in using advanced imaging and molecular markers for cancer risk assessment, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven low-risk PCa (PSA ≤10 ng/ml; clinical stage ≤T2a, and biopsy ISUP GG 1) * Non-metastatic status at study inclusion (patient enrollment). * No prior or concomitant androgen deprivation therapy * Ability to understand a written informed consent and willingness to sign it. Exclusion Criteria: * Unable to tolerate a PSMA-PET scan * Unwillingness to be managed with AS * Receipt of neoadjuvant or curative-intent therapies * Pacemaker * Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy
Where this trial is running
Milan, Italy
- IRCCS Ospedale San Raffaele — Milan, Italy, Italy (RECRUITING)
Study contacts
- Study coordinator: Giorgio Gandaglia
- Email: gandaglia.giorgio@hsr.it
- Phone: +39 0226438068
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.
Conditions: Low-Risk Prostate Cancer