Clinical trial · Observational
Active Surveillance for Cancer of the Prostate (ASCaP)
The UCLA ASCAP Project is an Observational, Longitudinal, and Open-ended Study Aimed at Establishing a Structured Program of Non-interventional Follow-up for Localized Prostate Cancer.
NCT00949819CI-TRIAL-00112623ASCaPrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- no treatment
- description
- Men with previously untreated, early stage prostate cancer.
- interventionNames
- Other: Active surveillance
Primary outcomes (1)
- measure
- Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.
- timeFrame
- Interim data analysis will be made every year
Secondary outcomes (1)
- measure
- Determine the clinical predictors of disease progression. Measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer. Determine factors that lead to active intervention
- timeFrame
- Interim data analysis will be done each year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate. 2. Clinically localized prostate cancer: T1-2, NX or N0, MX or M0. 3. No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy). 4. Patient has elected Active Surveillance as preferred management plan for prostate cancer. 5. Patient consent has been obtained according to local Institutional Review Board . 6. Patient is accessible and compliant for follow-up. Exclusion Criteria: 1. Unwillingness or inability to undergo serial prostate biopsy. 2. Overall life expectancy less than 2 years 3. Advanced prostate cancer
References
Publications (1)
- DERIVEDMartin SC, Gonzalez S, Kwan L, Delfin M, Nguyen AV, Brisbane W, Felker E, Sisk A, Priester A, Natarajan S, Marks LS. Evolution of Active Surveillance of Prostate Cancer: Impact of Magnetic Resonance Imaging, Magnetic Resonance Imaging-Guided Biopsy, and Focal Therapy. J Urol. 2025 Aug;214(2):177-187. doi: 10.1097/JU.0000000000004559. Epub 2025 Apr 21. PMID 40257918