Prostate Cancer Clinical Trial
— TAPGOfficial title:
Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting
Verified date | November 2022 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 3350 |
Est. completion date | December 2030 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 76 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Queen Mary University of London |
Ahmad 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. — View Citation
Ahmad 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. — View Citation
Ahmad I, Singh LB, Yang ZH, Kalna G, Fleming J, Fisher G, Cooper C, Cuzick J, Berney DM, Moller H, Scardino P, Leung HY. Mir143 expression inversely correlates with nuclear ERK5 immunoreactivity in clinical prostate cancer. Br J Cancer. 2013 Jan 15;108(1):149-54. doi: 10.1038/bjc.2012.510. — View Citation
Attard G, Clark J, Ambroisine L, Fisher G, Kovacs G, Flohr P, Berney D, Foster CS, Fletcher A, Gerald WL, Moller H, Reuter V, De Bono JS, Scardino P, Cuzick J, Cooper CS; Transatlantic Prostate Group. Duplication of the fusion of TMPRSS2 to ERG sequences identifies fatal human prostate cancer. Oncogene. 2008 Jan 10;27(3):253-63. doi: 10.1038/sj.onc.1210640. Epub 2007 Jul 16. — View Citation
Attard G, Clark J, Ambroisine L, Mills IG, Fisher G, Flohr P, Reid A, Edwards S, Kovacs G, Berney D, Foster C, Massie CE, Fletcher A, De Bono JS, Scardino P, Cuzick J, Cooper CS; Transatlantic Prostate Group. Heterogeneity and clinical significance of ETV1 translocations in human prostate cancer. Br J Cancer. 2008 Jul 22;99(2):314-20. doi: 10.1038/sj.bjc.6604472. Epub 2008 Jul 1. — View Citation
Beltran 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. — View Citation
Berney 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. — View Citation
Berney DM, Beltran L, Sandu H, Soosay G, Moller H, Scardino P, Murphy J, Ahmad A, Cuzick J; Transatlantic Prostate Group. The percentage of high-grade prostatic adenocarcinoma in prostate biopsies significantly improves on Grade Groups in the prediction of prostate cancer death. Histopathology. 2019 Oct;75(4):589-597. doi: 10.1111/his.13888. Epub 2019 Aug 13. — View Citation
Berney DM, Fisher G, Kattan MW, Oliver RT, Moller H, Fearn P, Eastham J, Scardino P, Cuzick J, Reuter VE, Foster CS; Trans-Atlantic Prostate Group. Major shifts in the treatment and prognosis of prostate cancer due to changes in pathological diagnosis and grading. BJU Int. 2007 Dec;100(6):1240-4. doi: 10.1111/j.1464-410X.2007.07199.x. — View Citation
Berney DM, Fisher G, Kattan MW, Oliver RT, Moller H, Fearn P, Eastham J, Scardino P, Cuzick J, Reuter VE, Foster CS; Trans-Atlantic prostate group. Pitfalls in the diagnosis of prostatic cancer: retrospective review of 1791 cases with clinical outcome. Histopathology. 2007 Oct;51(4):452-7. doi: 10.1111/j.1365-2559.2007.02819.x. — View Citation
Berney DM, Gopalan A, Kudahetti S, Fisher G, Ambroisine L, Foster CS, Reuter V, Eastham J, Moller H, Kattan MW, Gerald W, Cooper C, Scardino P, Cuzick J. Ki-67 and outcome in clinically localised prostate cancer: analysis of conservatively treated prostate cancer patients from the Trans-Atlantic Prostate Group study. Br J Cancer. 2009 Mar 24;100(6):888-93. doi: 10.1038/sj.bjc.6604951. — View Citation
Clark J, Attard G, Jhavar S, Flohr P, Reid A, De-Bono J, Eeles R, Scardino P, Cuzick J, Fisher G, Parker MD, Foster CS, Berney D, Kovacs G, Cooper CS. Complex patterns of ETS gene alteration arise during cancer development in the human prostate. Oncogene. 2008 Mar 27;27(14):1993-2003. doi: 10.1038/sj.onc.1210843. Epub 2007 Oct 8. — View Citation
Cuzick J, Berney DM, Fisher G, Mesher D, Moller H, Reid JE, Perry M, Park J, Younus A, Gutin A, Foster CS, Scardino P, Lanchbury JS, Stone S; Transatlantic Prostate Group. Prognostic value of a cell cycle progression signature for prostate cancer death in a conservatively managed needle biopsy cohort. Br J Cancer. 2012 Mar 13;106(6):1095-9. doi: 10.1038/bjc.2012.39. Epub 2012 Feb 23. — View Citation
Cuzick J, Fisher G, Kattan MW, Berney D, Oliver T, Foster CS, Moller H, Reuter V, Fearn P, Eastham J, Scardino P; Transatlantic Prostate Group. Long-term outcome among men with conservatively treated localised prostate cancer. Br J Cancer. 2006 Nov 6;95(9):1186-94. doi: 10.1038/sj.bjc.6603411. — View Citation
Cuzick 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. — View Citation
Cuzick J, Swanson GP, Fisher G, Brothman AR, Berney DM, Reid JE, Mesher D, Speights VO, Stankiewicz E, Foster CS, Moller H, Scardino P, Warren JD, Park J, Younus A, Flake DD 2nd, Wagner S, Gutin A, Lanchbury JS, Stone S; Transatlantic Prostate Group. Prognostic value of an RNA expression signature derived from cell cycle proliferation genes in patients with prostate cancer: a retrospective study. Lancet Oncol. 2011 Mar;12(3):245-55. doi: 10.1016/S1470-2045(10)70295-3. — View Citation
Cuzick J, Yang ZH, Fisher G, Tikishvili E, Stone S, Lanchbury JS, Camacho N, Merson S, Brewer D, Cooper CS, Clark J, Berney DM, Moller H, Scardino P, Sangale Z; Transatlantic Prostate Group. Prognostic value of PTEN loss in men with conservatively managed localised prostate cancer. Br J Cancer. 2013 Jun 25;108(12):2582-9. doi: 10.1038/bjc.2013.248. Epub 2013 May 21. — View Citation
Eastham JA, Kattan MW, Fearn P, Fisher G, Berney DM, Oliver T, Foster CS, Moller H, Reuter V, Cuzick J, Scardino P; Transatlantic Prostate Group. Local progression among men with conservatively treated localized prostate cancer: results from the Transatlantic Prostate Group. Eur Urol. 2008 Feb;53(2):347-54. doi: 10.1016/j.eururo.2007.05.015. Epub 2007 May 30. — View Citation
Fisher G, Yang ZH, Kudahetti S, Moller H, Scardino P, Cuzick J, Berney DM; Transatlantic Prostate Group. Prognostic value of Ki-67 for prostate cancer death in a conservatively managed cohort. Br J Cancer. 2013 Feb 5;108(2):271-7. doi: 10.1038/bjc.2012.598. Epub 2013 Jan 17. — View Citation
Foster CS, Dodson AR, Ambroisine L, Fisher G, Moller H, Clark J, Attard G, De-Bono J, Scardino P, Reuter VE, Cooper CS, Berney DM, Cuzick J. Hsp-27 expression at diagnosis predicts poor clinical outcome in prostate cancer independent of ETS-gene rearrangement. Br J Cancer. 2009 Oct 6;101(7):1137-44. doi: 10.1038/sj.bjc.6605227. Epub 2009 Aug 25. — View Citation
Jeetle SS, Fisher G, Yang ZH, Stankiewicz E, Moller H, Cooper CS, Cuzick J, Berney DM; Trans-Atlantic Prostate Group. Neuroendocrine differentiation does not have independent prognostic value in conservatively treated prostate cancer. Virchows Arch. 2012 Aug;461(2):103-7. doi: 10.1007/s00428-012-1259-2. Epub 2012 Jul 6. — View Citation
Kammerer-Jacquet SF, Ahmad A, Moller H, Sandu H, Scardino P, Soosay G, Beltran L, Cuzick J, Berney DM. Ki-67 is an independent predictor of prostate cancer death in routine needle biopsy samples: proving utility for routine assessments. Mod Pathol. 2019 Sep;32(9):1303-1309. doi: 10.1038/s41379-019-0268-y. Epub 2019 Apr 11. — View Citation
Kattan MW, Cuzick J, Fisher G, Berney DM, Oliver T, Foster CS, Moller H, Reuter V, Fearn P, Eastham J, Scardino PT; Transatlantic Prostate Group. Nomogram incorporating PSA level to predict cancer-specific survival for men with clinically localized prostate cancer managed without curative intent. Cancer. 2008 Jan 1;112(1):69-74. doi: 10.1002/cncr.23106. — View Citation
Kudahetti S, Fisher G, Ambroisine L, Foster C, Reuter V, Eastham J, Moller H, Kattan MW, Cooper CS, Scardino P, Cuzick J, Berney DM. p53 immunochemistry is an independent prognostic marker for outcome in conservatively treated prostate cancer. BJU Int. 2009 Jul;104(1):20-4. doi: 10.1111/j.1464-410X.2009.08407.x. Epub 2009 Feb 23. — View Citation
Kudahetti SC, Fisher G, Ambroisine L, Prowse D, Kattan MW, Foster CS, Moller H, Oliver T, Fletcher A, Cooper C, Reuter V, Scardino P, Cuzick J, Berney DM; Transatlantic Prostate Group. Immunohistochemistry for p16, but not Rb or p21, is an independent predictor of prognosis in conservatively treated, clinically localised prostate cancer. Pathology. 2010;42(6):519-23. doi: 10.3109/00313025.2010.508788. — View Citation
Merson S, Yang ZH, Brewer D, Olmos D, Eichholz A, McCarthy F, Fisher G, Kovacs G, Berney DM, Foster CS, Moller H, Scardino P, Cuzick J, Cooper CS, Clark JP; Transatlantic Prostate Group. Focal amplification of the androgen receptor gene in hormone-naive human prostate cancer. Br J Cancer. 2014 Mar 18;110(6):1655-62. doi: 10.1038/bjc.2014.13. Epub 2014 Jan 30. — View Citation
O'Brien MF, Cronin AM, Fearn PA, Savage CJ, Smith B, Stasi J, Scardino PT, Fisher G, Cuzick J, Moller H, Oliver RT, Berney DM, Foster CS, Eastham JA, Vickers AJ, Lilja H; Trans-Atlantic Prostate Group. Evaluation of prediagnostic prostate-specific antigen dynamics as predictors of death from prostate cancer in patients treated conservatively. Int J Cancer. 2011 May 15;128(10):2373-81. doi: 10.1002/ijc.25570. — View Citation
Rajab R, Fisher G, Kattan MW, Foster CS, Moller H, Oliver T, Reuter V, Scardino PT, Cuzick J, Berney DM; Transatlantic Prostate Group. An improved prognostic model for stage T1a and T1b prostate cancer by assessments of cancer extent. Mod Pathol. 2011 Jan;24(1):58-63. doi: 10.1038/modpathol.2010.182. Epub 2010 Sep 10. — View Citation
Rajab R, Fisher G, Kattan MW, Foster CS, Oliver T, Moller H, Reuter V, Scardino P, Cuzick J, Berney DM; Transatlantic Prostate Group. Measurements of cancer extent in a conservatively treated prostate cancer biopsy cohort. Virchows Arch. 2010 Nov;457(5):547-53. doi: 10.1007/s00428-010-0971-z. Epub 2010 Sep 9. — View Citation
Reid AH, Attard G, Ambroisine L, Fisher G, Kovacs G, Brewer D, Clark J, Flohr P, Edwards S, Berney DM, Foster CS, Fletcher A, Gerald WL, Moller H, Reuter VE, Scardino PT, Cuzick J, de Bono JS, Cooper CS; Transatlantic Prostate Group. Molecular characterisation of ERG, ETV1 and PTEN gene loci identifies patients at low and high risk of death from prostate cancer. Br J Cancer. 2010 Feb 16;102(4):678-84. doi: 10.1038/sj.bjc.6605554. Epub 2010 Jan 26. — View Citation
Shan L, Ambroisine L, Clark J, Yanez-Munoz RJ, Fisher G, Kudahetti SC, Yang J, Kia S, Mao X, Fletcher A, Flohr P, Edwards S, Attard G, De-Bono J, Young BD, Foster CS, Reuter V, Moller H, Oliver TD, Berney DM, Scardino P, Cuzick J, Cooper CS, Lu YJ; Transatlantic Prostate Group. The identification of chromosomal translocation, t(4;6)(q22;q15), in prostate cancer. Prostate Cancer Prostatic Dis. 2010 Jun;13(2):117-25. doi: 10.1038/pcan.2010.2. Epub 2010 Feb 23. — View Citation
Stankiewicz 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. — View Citation
Thomsen MK, Ambroisine L, Wynn S, Cheah KS, Foster CS, Fisher G, Berney DM, Moller H, Reuter VE, Scardino P, Cuzick J, Ragavan N, Singh PB, Martin FL, Butler CM, Cooper CS, Swain A; Transatlantic Prostate Group. SOX9 elevation in the prostate promotes proliferation and cooperates with PTEN loss to drive tumor formation. Cancer Res. 2010 Feb 1;70(3):979-87. doi: 10.1158/0008-5472.CAN-09-2370. Epub 2010 Jan 26. — View Citation
Vasiljevic N, Ahmad AS, Beesley C, Thorat MA, Fisher G, Berney DM, Moller H, Yu Y, Lu YJ, Cuzick J, Foster CS, Lorincz AT. Association between DNA methylation of HSPB1 and death in low Gleason score prostate cancer. Prostate Cancer Prostatic Dis. 2013 Mar;16(1):35-40. doi: 10.1038/pcan.2012.47. Epub 2012 Nov 20. — View Citation
Vasiljevic N, Ahmad AS, Carter PD, Fisher G, Berney DM, Foster CS, Cuzick J, Lorincz AT. DNA methylation of PITX2 predicts poor survival in men with prostate cancer. Biomark Med. 2014;8(9):1143-50. doi: 10.2217/bmm.14.41. — View Citation
Vasiljevic N, Ahmad AS, Thorat MA, Fisher G, Berney DM, Moller H, Foster CS, Cuzick J, Lorincz AT. DNA methylation gene-based models indicating independent poor outcome in prostate cancer. BMC Cancer. 2014 Sep 6;14:655. doi: 10.1186/1471-2407-14-655. — View Citation
Yao S, Bee A, Brewer D, Dodson A, Beesley C, Ke Y, Ambroisine L, Fisher G, Moller H, Dickinson T, Gerard P, Lian LY, Risk J, Lane B, Smith P, Reuter V, Berney D, Gosden C, Scardino P, Cuzick J, Djamgoz MB, Cooper C, Foster CS. PRKC-zeta Expression Promotes the Aggressive Phenotype of Human Prostate Cancer Cells and Is a Novel Target for Therapeutic Intervention. Genes Cancer. 2010 May;1(5):444-64. doi: 10.1177/1947601910376079. — View Citation
* Note: There are 37 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-specific survival | Time from date of inclusion until death from prostate cancer. | From date of inclusion to date of death from prostate cancer, assessed up to 30 years. | |
Primary | Overall survival | Time from date of inclusion until death from any cause. | From date of inclusion to date of death from any cause, assessed up to 30 years. | |
Secondary | To evaluate a correlation between serum PSA level and prostate cancer-specific survival. | Correlation of serum PSA level taken within 6 months of date of inclusion compared to death from prostate cancer. | From date of inclusion to date of death from prostate cancer, assessed up to 30 years. | |
Secondary | To evaluate a correlation between Gleason score and prostate cancer-specific survival. | Correlation of Gleason Score at date of inclusion compared to death from prostate cancer. | From date of inclusion to date of death from prostate cancer, assessed up to 30 years. | |
Secondary | To evaluate an association between clinical stage and prostate cancer-specific survival. | Stratification of clinical stage at date of inclusion compared to death from prostate cancer. | From date of inclusion to date of death from any cause, assessed up to 30 years. | |
Secondary | To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer. | Correlation of ki-67-positive cells compared to prostate cancer-specific survival. | From date of inclusion to date of death from prostate cancer, assessed up to 30 years. | |
Secondary | To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer. | Correlation of ki-67-positive cells compared to overall cancer-specific survival. | From date of inclusion to date of death from any cause, assessed up to 30 years. | |
Secondary | To evaluate ERG-ETV1 biomarker predictors of prognosis in early prostate cancer. | Correlation of ERG-ETV1 rearrangement status compared to prostate cancer-specific survival. | From date of inclusion to date of death from prostate cancer, assessed up to 30 years. |
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