Spanish Urological Association Registry of Patients on Active Surveillance

Launched by FUNDACIÓN INSTITUTO VALENCIANO DE ONCOLOGÍA · Aug 9, 2016

Keywords

ClinConnect Summary

The Spanish Urological Association is conducting a clinical trial to study the effectiveness of active surveillance for men with prostate cancer. Active surveillance is a way to monitor the cancer closely without immediately starting treatment, which helps avoid unnecessary treatments that may not be needed. The goal of this study is to gather information about how well this approach works across different healthcare centers in Spain, as practices can vary widely. Researchers believe that with proper monitoring, the chance of dying specifically from prostate cancer during active surveillance is low—less than 5% over 15 years.

To participate in this trial, men aged between 65 and 80 who have been diagnosed with early-stage prostate cancer may be eligible. Key criteria include having a low prostate-specific antigen (PSA) level and a specific type of cancer called adenocarcinoma with a low Gleason score, which helps determine how aggressive the cancer is. Participants will be regularly monitored and may need to undergo repeat biopsies to ensure the cancer remains stable. Those interested should be willing to understand the process and sign consent forms. This study aims to improve care for men with prostate cancer by providing more consistent data on active surveillance.

Gender

MALE

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.