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This observational study was designed to evaluate progression free survival after PSMA-PET/CT based salvage approach for patients affected by biochemical relapse after radical prostatectomy.
This is a prospective observational multicenter study including patients treated with upfront radical prostatectomy +/- postoperative prostate bed radiotherapy, with histological result of Prostate adenocarcinoma, affected by biochemical relapse (defined as PSA>/= 0.2 ng/ml) with a PSA at recurrence </=1 ng/ml. Patients will be staged with centralized 68 Ga- PSMA PET/CT and treated with a pre-defined approach based on 68 Ga-PSMA PET/CT findings.
The predefined approach will consist in the following flowchart:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients affected by biochemical relapse after radical prostatectomy undergoing staging PSMA-PET/CT and baseline blood sample for miRNA panel assessment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | PFS is defined as time from end of salvage treatment performed at first relapse to documented biochemical progression or radiological progression (or both), death from any cause or censoring at date of last follow-up. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time between end of tailored treatment after 68Ga-PSMA PET/CT and death. | 2 years |
| Cause-specific survival | Time between end of tailored treatment and death for prostate Cancer. |
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Inclusion Criteria:
Exclusion Criteria:
Prostate cancer male patient
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Patient affected by biochemical recurrence after radical prostatectomy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Livi, Prof. | Contact | +390557947264 | lorenzo.livi@unifi.it |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Livi, Prof. | Azienda Ospedaliero-Universitaria Careggi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Careggi Radiation Oncology Unit | Recruiting | Florence | 50134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27568654 | Result | Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25. | |
| 23707439 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Panel of miRNA (miR-186, miR-26a, miR-374a, miR-410, miR-660)
| 2 years |
| Radiological Progression Free Survival | The occurrence of any new lesion detectable with PSMA. PET/CT and/or any other molecular/radiological exam, which will be performed in case of biochemical or clinical progression. | 2 years |
| Quality of Life | Record rate of patients with impaired quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 | 2 years |
| Quality of Life | Record rate of patients with impaired quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-PR25 | 2 years |
| Management Change | Assess the proportion of management changes induced by positive PSMA PET/CT results. | 2 years |
| Association between PSMA PET/CT Detection Rate and specific miRNA panel | Association between PSMA PET/CT Detection Rate and specific miRNA panel | 2 year |
| Result |
| Thompson IM, Valicenti RK, Albertsen P, Davis BJ, Goldenberg SL, Hahn C, Klein E, Michalski J, Roach M, Sartor O, Wolf JS Jr, Faraday MM. Adjuvant and salvage radiotherapy after prostatectomy: AUA/ASTRO Guideline. J Urol. 2013 Aug;190(2):441-9. doi: 10.1016/j.juro.2013.05.032. Epub 2013 May 21. |
| 31042111 | Result | Pisansky TM, Thompson IM, Valicenti RK, D'Amico AV, Selvarajah S. Adjuvant and Salvage Radiotherapy after Prostatectomy: ASTRO/AUA Guideline Amendment 2018-2019. J Urol. 2019 Sep;202(3):533-538. doi: 10.1097/JU.0000000000000295. Epub 2019 Aug 8. |
| 27528718 | Result | Tendulkar RD, Agrawal S, Gao T, Efstathiou JA, Pisansky TM, Michalski JM, Koontz BF, Hamstra DA, Feng FY, Liauw SL, Abramowitz MC, Pollack A, Anscher MS, Moghanaki D, Den RB, Stephans KL, Zietman AL, Lee WR, Kattan MW, Stephenson AJ. Contemporary Update of a Multi-Institutional Predictive Nomogram for Salvage Radiotherapy After Radical Prostatectomy. J Clin Oncol. 2016 Oct 20;34(30):3648-3654. doi: 10.1200/JCO.2016.67.9647. |
| 27591931 | Result | Cornford P, Bellmunt J, Bolla M, Briers E, De Santis M, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, van der Poel HG, van der Kwast TH, Rouviere O, Wiegel T, Mottet N. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part II: Treatment of Relapsing, Metastatic, and Castration-Resistant Prostate Cancer. Eur Urol. 2017 Apr;71(4):630-642. doi: 10.1016/j.eururo.2016.08.002. Epub 2016 Aug 31. |
| 28497198 | Result | Afshar-Oromieh A, Holland-Letz T, Giesel FL, Kratochwil C, Mier W, Haufe S, Debus N, Eder M, Eisenhut M, Schafer M, Neels O, Hohenfellner M, Kopka K, Kauczor HU, Debus J, Haberkorn U. Diagnostic performance of 68Ga-PSMA-11 (HBED-CC) PET/CT in patients with recurrent prostate cancer: evaluation in 1007 patients. Eur J Nucl Med Mol Imaging. 2017 Aug;44(8):1258-1268. doi: 10.1007/s00259-017-3711-7. Epub 2017 May 12. |
| 31375469 | Result | Calais J, Ceci F, Eiber M, Hope TA, Hofman MS, Rischpler C, Bach-Gansmo T, Nanni C, Savir-Baruch B, Elashoff D, Grogan T, Dahlbom M, Slavik R, Gartmann J, Nguyen K, Lok V, Jadvar H, Kishan AU, Rettig MB, Reiter RE, Fendler WP, Czernin J. 18F-fluciclovine PET-CT and 68Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial. Lancet Oncol. 2019 Sep;20(9):1286-1294. doi: 10.1016/S1470-2045(19)30415-2. Epub 2019 Jul 30. |
| 25240974 | Result | Ost P, Bossi A, Decaestecker K, De Meerleer G, Giannarini G, Karnes RJ, Roach M 3rd, Briganti A. Metastasis-directed therapy of regional and distant recurrences after curative treatment of prostate cancer: a systematic review of the literature. Eur Urol. 2015 May;67(5):852-63. doi: 10.1016/j.eururo.2014.09.004. Epub 2014 Sep 17. |
| 32314028 | Result | Deandreis D, Guarneri A, Ceci F, Lillaz B, Bartoncini S, Oderda M, Nicolotti DG, Pilati E, Passera R, Zitella A, Bello M, Parise R, Carlevato R, Ricardi U, Gontero P. 68Ga-PSMA-11 PET/CT in recurrent hormone-sensitive prostate cancer (HSPC): a prospective single-centre study in patients eligible for salvage therapy. Eur J Nucl Med Mol Imaging. 2020 Nov;47(12):2804-2815. doi: 10.1007/s00259-020-04809-8. Epub 2020 Apr 20. |
| 24517338 | Result | Erdmann K, Kaulke K, Thomae C, Huebner D, Sergon M, Froehner M, Wirth MP, Fuessel S. Elevated expression of prostate cancer-associated genes is linked to down-regulation of microRNAs. BMC Cancer. 2014 Feb 11;14:82. doi: 10.1186/1471-2407-14-82. |
| 31092381 | Result | D'Angelillo RM, Francolini G, Ingrosso G, Ravo V, Triggiani L, Magli A, Mazzeo E, Arcangeli S, Alongi F, Jereczek-Fossa BA, Pergolizzi S, Pappagallo GL, Magrini SM. Consensus statements on ablative radiotherapy for oligometastatic prostate cancer: A position paper of Italian Association of Radiotherapy and Clinical Oncology (AIRO). Crit Rev Oncol Hematol. 2019 Jun;138:24-28. doi: 10.1016/j.critrevonc.2019.03.014. Epub 2019 Apr 1. |
| 31629656 | Result | Carrie C, Magne N, Burban-Provost P, Sargos P, Latorzeff I, Lagrange JL, Supiot S, Belkacemi Y, Peiffert D, Allouache N, Dubray BM, Servagi-Vernat S, Suchaud JP, Crehange G, Guerif S, Brihoum M, Barbier N, Graff-Cailleaud P, Ruffion A, Dussart S, Ferlay C, Chabaud S. Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial. Lancet Oncol. 2019 Dec;20(12):1740-1749. doi: 10.1016/S1470-2045(19)30486-3. Epub 2019 Oct 16. |
| 41698328 | Derived | Nikitas J, Smith CP, Armstrong WR, Murthy V, Grogan T, Clark K, Moore J, Roberts M, Farolfi A, Reiter RE, Rettig MB, Shen J, Valle LF, Nickols NG, Steinberg ML, Czernin J, Kishan AU, Calais J. Five-Year Outcomes After Prostate-Specific Membrane Antigen PET/CT-Guided Salvage Radiotherapy Following Radical Prostatectomy. J Natl Compr Canc Netw. 2026 Feb;24(2):11-18. doi: 10.6004/jnccn.2025.7102. |
| 37290915 | Derived | Francolini G, Banini M, Di Cataldo V, Detti B, Caini S, Loi M, Simontacchi G, Desideri I, Greto D, Valzano M, Roghi M, Serni S, Vaggelli L, Salvestrini V, Visani L, Becherini C, Olmetto E, Franzese C, Baldaccini D, Scorsetti M, Sollini M, Chiti A, Meattini I, Valicenti RK, Livi L. PSMA guided approach for bIoCHEmical relapse after prostatectomy- (PSICHE) trial (NCT05022914). Detection rate and treatment decision after 68Ga-PSMA PET/CT within a prospective study. Prostate. 2023 Sep;83(12):1201-1206. doi: 10.1002/pros.24579. Epub 2023 Jun 8. |
| 36242700 | Derived | Francolini G, Di Cataldo V, Detti B, Simontacchi G, Loi M, Valzano M, Desideri I, Meattini I, Mangoni M, Livi L. Killing two birds with a stone: how to maximise benefit from metastasis-directed therapy and modern systemic treatment in oligometastatic hormone sensitive prostate cancer. Clin Exp Metastasis. 2022 Dec;39(6):841-843. doi: 10.1007/s10585-022-10187-2. Epub 2022 Oct 15. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |