PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE

Prostate Cancer Clinical Trial

— PSICHE  

Official title:

Prostate-Specific Membrane Antigen (PSMA) Guided Approach for bIoCHEmical Relapse After Prostatectomy- A Prospective Observational Study-PSICHE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05022914
• Other study ID #: PSICHE
• Status: Recruiting
• Start date: January 19, 2021
• Est. completion date: January 19, 2027

Study information

• Verified date: August 2021
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: Lorenzo Livi, Prof.
• Phone: +390557947264
• Email: lorenzo.livi[@]unifi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 3 lesions or non-amenable with SBRT) and/or visceral disease: ADT+/-other systemic therapies available for metastatic hormone sensitive pCa at physician discretion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 19, 2027
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent
• 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:

• ADT administration within 6 months from study enrollment
• Persistent elevation of PSA after RP measured within 16 weeks from surgery (> 0.1 ng/ml)

Related Conditions & MeSH terms

• Neoplasms
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostate Cancer Recurrent
• Prostatic Neoplasms
• Recurrence

Locations

Country	Name	City	State
Italy	AOU Careggi Radiation Oncology Unit	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

References & Publications (12)

Afshar-Oromieh A, Holland-Letz T, Giesel FL, Kratochwil C, Mier W, Haufe S, Debus N, Eder M, Eisenhut M, Schäfer M, Neels O, Hohenfellner M, Kopka K, Kauczor HU, Debus J, Haberkorn U. Diagnostic performance of (68)Ga-PSMA-11 (HBED-CC) PET/CT in patients w — View Citation

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. (18)F-fluciclovin — View Citation

Carrie C, Magné 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 — View Citation

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, Rouvière O, Wiegel T, Mottet N. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part II: Treatment of Relapsing, Metast — View Citation

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 posit — View Citation

Deandreis D, Guarneri A, Ceci F, Lillaz B, Bartoncini S, Oderda M, Nicolotti DG, Pilati E, Passera R, Zitella A, Bellò M, Parise R, Carlevato R, Ricardi U, Gontero P. (68)Ga-PSMA-11 PET/CT in recurrent hormone-sensitive prostate cancer (HSPC): a prospecti — View Citation

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. — View Citation

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, Rouvière O, Schoots IG, Wiegel — View Citation

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. — View Citation

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. — View Citation

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 o — View Citation

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: 10.10 — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Overall Survival	Time between end of tailored treatment after 68Ga-PSMA PET/CT and death.	2 years
Secondary	Cause-specific survival	Time between end of tailored treatment and death for prostate Cancer.	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Management Change	Assess the proportion of management changes induced by positive PSMA PET/CT results.	2 years
Secondary	Association between PSMA PET/CT Detection Rate and specific miRNA panel	Association between PSMA PET/CT Detection Rate and specific miRNA panel	2 year