PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE
NCT ID: NCT05022914
Last Updated: 2021-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2021-01-19
2027-01-19
Brief Summary
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Detailed Description
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The predefined approach will consist in the following flowchart:
1. In negative 68Ga-PSMA PET/CT or positive findings within prostate bed: Prostate bed RT
2. In 68Ga-PSMA PET/CT detecting pelvic nodal recurrence amenable with stereotactic body radiation therapy (SBRT) on all sites of disease: SBRT to all positive nodal disease.
3. In abdominal nodal or bone oligometastatic disease amenable with stereotactic body radiation therapy (SBRT) on all sites of disease: SBRT on all sites of disease
4. In abdominal nodal or bone metastatic disease (\>3 lesions or non-amenable with SBRT) and/or visceral disease: ADT+/-other systemic therapies available for metastatic hormone sensitive pCa at physician discretion.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Patients affected by biochemical relapse after radical prostatectomy undergoing staging PSMA-PET/CT and baseline blood sample for miRNA panel assessment.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age \>18
* Patient suitable for 68Ga-PSMA PET/CT re-staging according to clinical practice (Previous radical prostatectomy with histological result of Prostate adenocarcinoma +/- postoperative prostate bed radiotherapy (adjuvant or salvage setting), with a biochemical relapse defined as a PSA \> 0.2 and \<1
Exclusion Criteria
* Persistent elevation of PSA after RP measured within 16 weeks from surgery (\> 0.1 ng/ml)
18 Years
MALE
No
Sponsors
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Azienda Ospedaliero-Universitaria Careggi
OTHER
Responsible Party
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Lorenzo Livi
Full Professor
Principal Investigators
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Lorenzo Livi, Prof.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria Careggi
Locations
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AOU Careggi Radiation Oncology Unit
Florence, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PSICHE
Identifier Type: -
Identifier Source: org_study_id
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