Clinical trial · Observational
Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting
NCT03912883CI-TRIAL-00097363TAPGactive not recruitingClinicalTrials.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 Trans-Atlantic Prostate Group (TAPG) was established to examine the hypothesis that through a detailed retrospective analysis of outcome in a group of men with clinically localised prostate cancer at diagnosis, variables such as biological, pathological and clinical markers, could be identified that might accurately predict the prognosis of clinically localised 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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Disease-specific survival
- timeFrame
- From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
- description
- Time from date of inclusion until death from prostate cancer.
- measure
- Overall survival
- timeFrame
- From date of inclusion to date of death from any cause, assessed up to 30 years.
- description
- Time from date of inclusion until death from any cause.
Secondary outcomes (6)
- measure
- To evaluate a correlation between serum PSA level and prostate cancer-specific survival.
- timeFrame
- From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
- description
- Correlation of serum PSA level taken within 6 months of date of inclusion compared to death from prostate cancer.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be aged less than 76 years at the time of diagnosis * Patients must have had a baseline serum PSA level measured before starting any treatment and within six months of diagnosis * Patients must have been diagnosed between 1990 and 2006 with a clinically localized (clinical stage T1-T3, N0 or NX, MO or MX) prostate cancer, in the judgment of the treating physician * The initial diagnostic biopsy sample must be available for review. Patients should have (but are not required to have) tissue blocks available for review. * There must be no evidence of metastatic disease * While data collection will include review of the reports of any imaging studies of the prostate, bones, or soft tissues, these studies are not essential * Each patient should have had an adequate medical evaluation to document the status of disease for the first five years after diagnosis. Follow-up should include an annual PSA and digital rectal examination. Records will be reviewed to seek all information about medical evaluation after the time of diagnosis. Exclusion Criteria: * Patients older than 76 years at the time of diagnosis * Patients who have not had a baseline serum PSA level measured before starting any treatment * Patients who do not have the initial diagnosis biopsy sample for review * Patients with evidence of metastatic disease
References
Publications (37)
- BACKGROUNDBeltran L, Ahmad AS, Sandu H, Kudahetti S, Soosay G, Moller H, Cuzick J, Berney DM; Transatlantic Prostate Group. Histopathologic False-positive Diagnoses of Prostate Cancer in the Age of Immunohistochemistry. Am J Surg Pathol. 2019 Mar;43(3):361-368. doi: 10.1097/PAS.0000000000001202. PMID 30531531
- BACKGROUNDAhmad AS, Parameshwaran V, Beltran L, Fisher G, North BV, Greenberg D, Soosay G, Moller H, Scardino P, Cuzick J, Berney DM; Transatlantic Prostate Group. Should reporting of peri-neural invasion and extra prostatic extension be mandatory in prostate cancer biopsies? correlation with outcome in biopsy cases treated conservatively. Oncotarget. 2018 Apr 17;9(29):20555-20562. doi: 10.18632/oncotarget.24994. eCollection 2018 Apr 17. PMID 29755671
- BACKGROUNDStankiewicz E, Mao X, Mangham DC, Xu L, Yeste-Velasco M, Fisher G, North B, Chaplin T, Young B, Wang Y, Kaur Bansal J, Kudahetti S, Spencer L, Foster CS, Moller H, Scardino P, Oliver RT, Shamash J, Cuzick J, Cooper CS, Berney DM, Lu YJ. Identification of FBXL4 as a Metastasis Associated Gene in Prostate Cancer. Sci Rep. 2017 Jul 11;7(1):5124. doi: 10.1038/s41598-017-05209-z. PMID 28698647
- BACKGROUNDBerney DM, Beltran L, Fisher G, North BV, Greenberg D, Moller H, Soosay G, Scardino P, Cuzick J. Validation of a contemporary prostate cancer grading system using prostate cancer death as outcome. Br J Cancer. 2016 May 10;114(10):1078-83. doi: 10.1038/bjc.2016.86. Epub 2016 Apr 21. PMID 27100731
- BACKGROUNDAhmad AS, Vasiljevic N, Carter P, Berney DM, Moller H, Foster CS, Cuzick J, Lorincz AT. A novel DNA methylation score accurately predicts death from prostate cancer in men with low to intermediate clinical risk factors. Oncotarget. 2016 Nov 1;7(44):71833-71840. doi: 10.18632/oncotarget.12377. PMID 27708246
- BACKGROUNDCuzick J, Stone S, Fisher G, Yang ZH, North BV, Berney DM, Beltran L, Greenberg D, Moller H, Reid JE, Gutin A, Lanchbury JS, Brawer M, Scardino P. Validation of an RNA cell cycle progression score for predicting death from prostate cancer in a conservatively managed needle biopsy cohort. Br J Cancer. 2015 Jul 28;113(3):382-9. doi: 10.1038/bjc.2015.223. Epub 2015 Jun 23.