Clinical trial · Observational
The Active Surveillance Study
Active Surveillance Study for Prostate Cancer Management for Men at Higher Genetic Risk Compared With Men at No Known Higher Genetic Risk.
NCT05810467CI-TRIAL-00102442ASrecruitingClinicalTrials.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)
The Active Surveillance study is a prospective study developed to look at the association of biomarkers with PrCa presentation and progression among men on Active Surveillance and stratify it by their genetic risk. This study will also investigate the incidence and progression by differing genetic risks.
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 (2)
- label
- Control Arm
- description
- Men diagnosed with low-grade PrCa undergoing Active Surveillance and are not known to have an increased genetic risk for PrCa e.g. Men without high-risk mutations or high polygenic risk score (PRS). Men diagnosed with PrCa suitable for Active Surveillance who wish to continue follow up at collaborating hospitals will be offered enrolment in collection and monitoring of various biological samples. These men will act as a control group, as they do not have a known higher genetic risk of PrCa. The control group will have genetic analysis carried out on provided saliva or blood samples. Their family history will be captured. They will be genotyped using the latest technology and at a minimum have PRS testing done. Men may be moved out of the control arm and into the high-risk arm, if identified at a higher genetic risk or as having a strong family history of PrCa for the purposes of the analysis. Any clinically significant genetic results will be discussed with the participants.
- interventionNames
- Other: Active Surveillance
- label
- High-risk Arm
- description
- Men who have been diagnosed with low grade PrCa and are undergoing active surveillance who are at genetically higher risk of PrCa defined as: 1. Men of any ancestry with a family history defined as at least one first degree (or second degree if through the female line) relative with PrCa diagnosed at \<70 years (diagnosis verified). 2. Men of Black African or Caribbean ancestry irrespective of family history 3. Men of any ancestry known to carry a mutation in a high-risk gene thought to cause a higher risk of prostate cancer. 4. Men of ancestry with a high genetic risk (common and/or rare variants) for prostate cancer resulting in relative risk (RR) of ≥2.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Men ≥18 years old under the care of an Active Surveillance clinic. * Known diagnosis of PrCa, deemed suitable for Active surveillance at multi-disciplinary meeting (MDT). * Men at genetically higher PrCa risk who are either: (1) Men of any ancestry with a positive family history of PrCa defined as: * Having a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at \<70 years * Having two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at \<70 years * Having three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age Or (2) Men of Black African or Black African-Caribbean ancestry defined as: * Both parents and all 4 grandparents from that origin Or (3) Men of any ancestry with a pathogenic mutation in a gene thought to cause a higher risk of prostate cancer: (including BRCA1, BRCA2, ATM, PALB2, MLH1, MSH2, MSH6, CHEK2 and other DNA repair gene mutations as listed in appendix A) Or (4) Men of any ancestry with a high genetic risk (common and/or rare variants) for PrCa resulting in a RR of ≥2 of PrCa * Men of any ancestry with no known high risk genetic factors who have been diagnosed with low grade PrCa and deemed suitable for Active Surveillance at multi-disciplinary meeting (control group) as defined in the 4 criteria above. * Who performance status 0-2 * Absence of any psychological, familial, sociological, or geographical situation potentially hampering compliance with the study protocol and follow-up schedule. Exclusion Criteria * No PrCa diagnosis * PrCa diagnosis that is not deemed suitable for active surveillance at multi-disciplinary meeting * Any significant psychological conditions that may be worsened or exacerbated by participation in the study
References
Publications (5)
- BACKGROUNDHamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14. PMID 27626136
- BACKGROUNDTseng KS, Landis P, Epstein JI, Trock BJ, Carter HB. Risk stratification of men choosing surveillance for low risk prostate cancer. J Urol. 2010 May;183(5):1779-85. doi: 10.1016/j.juro.2010.01.001. Epub 2010 Mar 20. PMID 20304433
- BACKGROUNDBokhorst LP, Valdagni R, Rannikko A, Kakehi Y, Pickles T, Bangma CH, Roobol MJ; PRIAS study group. A Decade of Active Surveillance in the PRIAS Study: An Update and Evaluation of the Criteria Used to Recommend a Switch to Active Treatment. Eur Urol. 2016 Dec;70(6):954-960. doi: 10.1016/j.eururo.2016.06.007. Epub 2016 Jun 19. PMID 27329565
- BACKGROUNDPorten SP, Whitson JM, Cowan JE, Cooperberg MR, Shinohara K, Perez N, Greene KL, Meng MV, Carroll PR. Changes in prostate cancer grade on serial biopsy in men undergoing active surveillance. J Clin Oncol. 2011 Jul 10;29(20):2795-800. doi: 10.1200/JCO.2010.33.0134. Epub 2011 May 31. PMID 21632511
- BACKGROUNDBerglund RK, Masterson TA, Vora KC, Eggener SE, Eastham JA, Guillonneau BD. Pathological upgrading and up staging with immediate repeat biopsy in patients eligible for active surveillance. J Urol. 2008 Nov;180(5):1964-7; discussion 1967-8. doi: 10.1016/j.juro.2008.07.051. Epub 2008 Sep 17. PMID 18801515