Registry of prostate cancer patients on active surveillance in Spain

Spanish Urological Association Registry of Patients on Active Surveillance

This study is creating a registry of prostate cancer patients in Spain who are being monitored without immediate treatment to see how well this approach works over time.

Quick facts

• Study type: Observational
• Enrollment: 946 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: Fundación Instituto Valenciano de Oncología (Academic / other)
• Locations: 1 site (Valencia)
• Trial ID: NCT02865330 on ClinicalTrials.gov

What this trial studies

This multicenter observational study aims to create a comprehensive registry of patients with prostate cancer who are undergoing active surveillance in Spain. It includes both retrospective and prospective data collection from various medical centers affiliated with the Spanish Urological Association. The study seeks to standardize the approach to active surveillance and monitor outcomes over time, with a hypothesis that cancer-specific mortality for patients eligible for active surveillance will be less than 5% over 15 years. The registry will help address the variability in active surveillance practices across different centers in Spain.

Who should consider this trial

Good fit: Ideal candidates for this study are men under 80 years old with low to intermediate risk prostate cancer who meet specific clinical criteria for active surveillance.

Not a fit: Patients with a history of atypical small acinar proliferation or those unwilling to undergo repeat biopsies may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could lead to improved management strategies for prostate cancer, reducing unnecessary treatments and associated side effects.

How similar studies have performed: Other studies have shown success with similar registries and active surveillance approaches, indicating potential for meaningful insights and improvements in patient care.

Eligibility criteria

Inclusion Criteria:

1. PSA ≤ 10 ng / mL; if prostate volume\> 60 cc in transrectal, ultrasound includable with PSA\>10 ng / ml if PSAD \<0.20
2. Local Stadium DRE; cT1c -cT2a
3. Diagnosis of transrectal ultrasound guided biopsy minimum 10 cylinders
4. Adenocarcinoma Prostate Gleason ≤ 6 (3 + 3) with local and central pathology review
5. Maximum number of cylinders = 2 and none of them more than 5mm tumor or more than 50% of assignment
6. \<80 years and greater expectancy to 10 years life (Charlson score)
7. Patients able to understand active surveillance and sign the Informed Consent

Exclusion Criteria:

1. Patient not be able to accept up with repeat biopsies
2. Patient who does not want to sign the Informed Consent
3. Hospital where the possibility of a biopsy confirmation at 6 months is not guaranteed under the terms of the inclusion criteria
4. Patients with a history of ASAP (atypical small acinar proliferation or atypical microglands)
5. Patients with treatment with inhibitors of 5-alpha-reductase as dutasteride (Avidart®) and finasteride (Proscar®) during the previous six months
6. Patients who have undergone during the 6 months prior to any treatment symptomatic benign prostate hyperplasia, or any invasive urological procedure. It can be associated with an increase of PSA prior to phlebotomy. These therapies include, but they are not limited to, prostate biopsy, thermotherapy, microwave therapy, laser, urethral resection of the prostate, urethral catheterization and the lower genitourinary tract endoscopy.

Where this trial is running

Valencia

• Instituto Valenciano de Oncología — Valencia, Spain (Recruiting)

Study contacts

• Principal investigator: Jose Rubio Briones, MD, PhD — Ivo
• Study coordinator: Jose Rubio Briones, MD, PhD

Conditions Prostate Cancer; Intermediate Risk Prostate Cancer; Low Risk Prostate Cancer; Active Surveillance