[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer

NCT05936658 | Active Not Recruiting Phase 3

• 1 other identifier: FC303-3-2
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 6

Brief Summary

This is a multi-center, open-label, single arm Phase III clinical trial for the diagnostic efficacy assessment and safety evaluation by \[18F\]Florastamin PET/CT imaging examination to determine the presence of recurrent or metastatic prostate cancer in patients whose recurrent or metastatic lesions have been confirmed through the conventional imaging.

Conditions

High Risk Prostate Carcinoma

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The positive predictive values(PPV) Evaluation of [18F]Florastamine PET/CT

  The positive predictive values (PPV) of \[18F\]Florastamin PET/CT imaging for the detection of recurrent or metastatic prostate cancer in subjects are evaluated. The PPV is calculated by TP/(TP+FP) x 100% for patients with positive \[ 18F\]Florastamin PET/CT. True positive is defined as being determined to be positive for prostate cancer according to histopathological results of tissues removed from \[18F\]Florastamin PET/CT and a biopsy or PLND. False positive is defined as being determined negative for prostate cancer according to the histopathological results of tissues removed through a biopsy or PLND, but determined positive for prostate cancer by \[18F\]Florastamin PET/CT.

  [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).

Secondary Outcomes (5)

• Detection rates of [18F]Florastamin PET/CT imaging

  [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).

• The sensitivity of [18F]Florastamin PET/CT imaging

  [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).

• The positive predictive values (PPV) Comparison of [18F]Florastamin PET/CT imaging and conventional imaging

  [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).

• Evaluation of the standard uptake values of [18F]Florastamin in the lesion location

  [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).

• Percentage of subjects who found a different lesion in conventional imaging

  Conventional imaging conduct at V1(-42 Days ~ 1 Days). [18F]Florastamin PET/CT conducts at V2(1 Day/Efficacy & Safety evaluation). Biopy or PLND conducts V3(1Day ~ 28Day/Efficacy & Safety evaluation).

Study Arms (1)

The positive predictive values (PPV) of [18F]Florastamin PET/CT imaging

OTHER

The positive predictive values (PPV) of \[18F\]Florastamin PET/CT imaging for the detection of recurrent or metastatic prostate cancer in subjects are evaluated.

Drug: [F-18]Florastamin

Interventions

[F-18]Florastamin DRUG

A single dose of \[F-18\]Florastamin at 10 ± 1 mCi is intravenously administered only to the subjects who meet the inclusion/exclusion criteria, and then \[F-18\]Florastamin PET/CT imaging is performed from the head to thigh after 105 ± 15 minutes (care should be taken to prevent extravasation of the radiopharmaceutical product).

The positive predictive values (PPV) of [18F]Florastamin PET/CT imaging

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Male aged 19 and older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male aged 19 and older
• Patients histopathologically diagnosed with prostate cancer
• Patients who can undergo a percutaneous biopsy or PLND for more than one lesion locations with locally recurrent, new or advanced metastasis as confirmed by MRI or whole-body bone scan performed within 6 weeks prior to screening
• Patients whose survival is expected to be at least 6 months with ECOG Performance Status ≤ 2
• Those whose ICF was signed by themselves or their legal guardian or representative after sufficient explanation was given by the investigator about the study objectives, details, characteristics of the investigational device, etc. before enrolled for the study.

You may not qualify if:

• Subjects who have the following disease within 6 months prior to screening:
• Heart failure that falls into Class III or IV heart failure classified by New York Heart Association;
• Embolism pulmonary, acute coronary syndrome (unstable angina or myocardial infarction);
• Acute severe respiratory syndrome;
• Cerebrovascular disease such as stroke;
• Uncontrollable hypertension (SBP \> 160 mmHg or DBP \> 90 mmHg);
• Uncontrollable heart arrhythmia;
• Blood clotting disorder.
• Patients who are receiving radiation therapy or ablative therapy on the prostate bed within 12 weeks prior to screening
• Patients whose method of systemic treatment for prostate cancer (e.g., hormone therapy, biological therapy, radiation therapy, or chemotherapy) has changed within 3 months prior to screening, or who have to change orstart systemic treatment for prostate cancer while the study is being conducted (until before a biopsy or PLND) However, when systemic treatment has changed into watchful waiting, the patient can participate in the study.
• According to the laboratory test results, patients who meet the following criteria:
• Platelet counts (PLT) \< 50,000/μL;
• Serum creatinine \> 1.8 mg/dL or eGFR (or GFR) \< 30 mL/min/1.7 m2;
• AST and ALT \> 2.5 x upper limit of normal (ULN) (however, for a patient whose hepatic metastasis has been confirmed, AST and ALT \> 5 x ULN).
• Subjects who are suffering from active infectious disease at screening and determined unfit to participate in this study;

Sponsors & Collaborators

• FutureChem: lead

Study Sites (6)

National Cancer Center

Gyeonggi-do, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

Ewha womans university mokdong medical center

Soeul, South Korea

Location

Related Publications (57)

• Amling CL, Blute ML, Bergstralh EJ, Seay TM, Slezak J, Zincke H. Long-term hazard of progression after radical prostatectomy for clinically localized prostate cancer: continued risk of biochemical failure after 5 years. J Urol. 2000 Jul;164(1):101-5.

  PMID: 10840432 BACKGROUND

• Antonarakis ES, Feng Z, Trock BJ, Humphreys EB, Carducci MA, Partin AW, Walsh PC, Eisenberger MA. The natural history of metastatic progression in men with prostate-specific antigen recurrence after radical prostatectomy: long-term follow-up. BJU Int. 2012 Jan;109(1):32-9. doi: 10.1111/j.1464-410X.2011.10422.x. Epub 2011 Jul 20.

  PMID: 21777360 BACKGROUND

• Bach-Gansmo T, Nanni C, Nieh PT, Zanoni L, Bogsrud TV, Sletten H, Korsan KA, Kieboom J, Tade FI, Odewole O, Chau A, Ward P, Goodman MM, Fanti S, Schuster DM, Willoch F. Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer. J Urol. 2017 Mar;197(3 Pt 1):676-683. doi: 10.1016/j.juro.2016.09.117. Epub 2016 Oct 13.

  PMID: 27746282 BACKGROUND

• Bauman G, Martin P, Thiessen JD, Taylor R, Moussa M, Gaed M, Rachinsky I, Kassam Z, Chin J, Pautler S, Lee TY, Valliant JF, Ward A. [18F]-DCFPyL Positron Emission Tomography/Magnetic Resonance Imaging for Localization of Dominant Intraprostatic Foci: First Experience. Eur Urol Focus. 2018 Sep;4(5):702-706. doi: 10.1016/j.euf.2016.10.002. Epub 2016 Oct 26.

  PMID: 28753797 BACKGROUND

• Blomqvist L, Carlsson S, Gjertsson P, Heintz E, Hultcrantz M, Mejare I, Andren O. Limited evidence for the use of imaging to detect prostate cancer: a systematic review. Eur J Radiol. 2014 Sep;83(9):1601-6. doi: 10.1016/j.ejrad.2014.06.028. Epub 2014 Jul 5.

  PMID: 25059597 BACKGROUND

• Bluemel C, Krebs M, Polat B, Linke F, Eiber M, Samnick S, Lapa C, Lassmann M, Riedmiller H, Czernin J, Rubello D, Bley T, Kropf S, Wester HJ, Buck AK, Herrmann K. 68Ga-PSMA-PET/CT in Patients With Biochemical Prostate Cancer Recurrence and Negative 18F-Choline-PET/CT. Clin Nucl Med. 2016 Jul;41(7):515-21. doi: 10.1097/RLU.0000000000001197.

  PMID: 26975008 BACKGROUND

• 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.

  PMID: 31375469 BACKGROUND

• Calais J, Fendler WP, Herrmann K, Eiber M, Ceci F. Comparison of 68Ga-PSMA-11 and 18F-Fluciclovine PET/CT in a Case Series of 10 Patients with Prostate Cancer Recurrence. J Nucl Med. 2018 May;59(5):789-794. doi: 10.2967/jnumed.117.203257. Epub 2017 Dec 14.

  PMID: 29242404 BACKGROUND

• Castellucci P, Fuccio C, Nanni C, Santi I, Rizzello A, Lodi F, Franceschelli A, Martorana G, Manferrari F, Fanti S. Influence of trigger PSA and PSA kinetics on 11C-Choline PET/CT detection rate in patients with biochemical relapse after radical prostatectomy. J Nucl Med. 2009 Sep;50(9):1394-400. doi: 10.2967/jnumed.108.061507. Epub 2009 Aug 18.

  PMID: 19690023 BACKGROUND

• Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8.

  PMID: 16985927 BACKGROUND

• Chausse G, Niazi T, Abikhzer GS, Probst SM. Biopsy-Proven Diffuse Mediastinal Prostate Cancer Metastases Negative on 18F-Fluorocholine, Diagnosed on 68Ga-PSMA and 18F-PSMA PET/CT. Clin Nucl Med. 2017 Oct;42(10):801-802. doi: 10.1097/RLU.0000000000001766.

  PMID: 28719448 BACKGROUND

• Chen Y, Pullambhatla M, Foss CA, Byun Y, Nimmagadda S, Senthamizhchelvan S, Sgouros G, Mease RC, Pomper MG. 2-(3-1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. Clin Cancer Res. 2011 Dec 15;17(24):7645-53. doi: 10.1158/1078-0432.CCR-11-1357. Epub 2011 Oct 31.

  PMID: 22042970 BACKGROUND

• de Jong IJ, Pruim J, Elsinga PH, Vaalburg W, Mensink HJ. 11C-choline positron emission tomography for the evaluation after treatment of localized prostate cancer. Eur Urol. 2003 Jul;44(1):32-8; discussion 38-9. doi: 10.1016/s0302-2838(03)00207-0.

  PMID: 12814672 BACKGROUND

• Dietlein M, Kobe C, Kuhnert G, Stockter S, Fischer T, Schomacker K, Schmidt M, Dietlein F, Zlatopolskiy BD, Krapf P, Richarz R, Neubauer S, Drzezga A, Neumaier B. Comparison of [(18)F]DCFPyL and [ (68)Ga]Ga-PSMA-HBED-CC for PSMA-PET Imaging in Patients with Relapsed Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):575-84. doi: 10.1007/s11307-015-0866-0.

  PMID: 26013479 BACKGROUND

• Eiber M, Maurer T, Souvatzoglou M, Beer AJ, Ruffani A, Haller B, Graner FP, Kubler H, Haberkorn U, Eisenhut M, Wester HJ, Gschwend JE, Schwaiger M. Evaluation of Hybrid (6)(8)Ga-PSMA Ligand PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy. J Nucl Med. 2015 May;56(5):668-74. doi: 10.2967/jnumed.115.154153. Epub 2015 Mar 19.

  PMID: 25791990 BACKGROUND

• Evangelista L, Briganti A, Fanti S, Joniau S, Reske S, Schiavina R, Stief C, Thalmann GN, Picchio M. New Clinical Indications for (18)F/(11)C-choline, New Tracers for Positron Emission Tomography and a Promising Hybrid Device for Prostate Cancer Staging: A Systematic Review of the Literature. Eur Urol. 2016 Jul;70(1):161-175. doi: 10.1016/j.eururo.2016.01.029. Epub 2016 Feb 2.

  PMID: 26850970 BACKGROUND

• Fendler WP, Calais J, Eiber M, Flavell RR, Mishoe A, Feng FY, Nguyen HG, Reiter RE, Rettig MB, Okamoto S, Emmett L, Zacho HD, Ilhan H, Wetter A, Rischpler C, Schoder H, Burger IA, Gartmann J, Smith R, Small EJ, Slavik R, Carroll PR, Herrmann K, Czernin J, Hope TA. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863. doi: 10.1001/jamaoncol.2019.0096.

  PMID: 30920593 BACKGROUND

• Ghosh A, Heston WD. Tumor target prostate specific membrane antigen (PSMA) and its regulation in prostate cancer. J Cell Biochem. 2004 Feb 15;91(3):528-39. doi: 10.1002/jcb.10661.

  PMID: 14755683 BACKGROUND

• Giovacchini G, Picchio M, Coradeschi E, Scattoni V, Bettinardi V, Cozzarini C, Freschi M, Fazio F, Messa C. [(11)C]choline uptake with PET/CT for the initial diagnosis of prostate cancer: relation to PSA levels, tumour stage and anti-androgenic therapy. Eur J Nucl Med Mol Imaging. 2008 Jun;35(6):1065-73. doi: 10.1007/s00259-008-0716-2. Epub 2008 Jan 16.

  PMID: 18200444 BACKGROUND

• Gorin MA, Rowe SP, Patel HD, Vidal I, Mana-Ay M, Javadi MS, Solnes LB, Ross AE, Schaeffer EM, Bivalacqua TJ, Partin AW, Pienta KJ, Szabo Z, De Marzo AM, Pomper MG, Allaf ME. Prostate Specific Membrane Antigen Targeted 18F-DCFPyL Positron Emission Tomography/Computerized Tomography for the Preoperative Staging of High Risk Prostate Cancer: Results of a Prospective, Phase II, Single Center Study. J Urol. 2018 Jan;199(1):126-132. doi: 10.1016/j.juro.2017.07.070. Epub 2017 Jul 20.

  PMID: 28736318 BACKGROUND

• Greco C, Cascini GL, Tamburrini O. Is there a role for positron emission tomography imaging in the early evaluation of prostate cancer relapse? Prostate Cancer Prostatic Dis. 2008;11(2):121-8. doi: 10.1038/sj.pcan.4501028. Epub 2008 Jan 8.

  PMID: 18180806 BACKGROUND

• Han M, Partin AW, Zahurak M, Piantadosi S, Epstein JI, Walsh PC. Biochemical (prostate specific antigen) recurrence probability following radical prostatectomy for clinically localized prostate cancer. J Urol. 2003 Feb;169(2):517-23. doi: 10.1097/01.ju.0000045749.90353.c7.

  PMID: 12544300 BACKGROUND

• Hillier SM, Maresca KP, Femia FJ, Marquis JC, Foss CA, Nguyen N, Zimmerman CN, Barrett JA, Eckelman WC, Pomper MG, Joyal JL, Babich JW. Preclinical evaluation of novel glutamate-urea-lysine analogues that target prostate-specific membrane antigen as molecular imaging pharmaceuticals for prostate cancer. Cancer Res. 2009 Sep 1;69(17):6932-40. doi: 10.1158/0008-5472.CAN-09-1682. Epub 2009 Aug 25.

  PMID: 19706750 BACKGROUND

• Hillier SM, Maresca KP, Lu G, Merkin RD, Marquis JC, Zimmerman CN, Eckelman WC, Joyal JL, Babich JW. 99mTc-labeled small-molecule inhibitors of prostate-specific membrane antigen for molecular imaging of prostate cancer. J Nucl Med. 2013 Aug;54(8):1369-76. doi: 10.2967/jnumed.112.116624. Epub 2013 Jun 3.

  PMID: 23733925 BACKGROUND

• Hofer C, Laubenbacher C, Block T, Breul J, Hartung R, Schwaiger M. Fluorine-18-fluorodeoxyglucose positron emission tomography is useless for the detection of local recurrence after radical prostatectomy. Eur Urol. 1999;36(1):31-5. doi: 10.1159/000019923.

  PMID: 10364652 BACKGROUND

• Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. doi: 10.1056/NEJMoa1001294.

  PMID: 20818862 BACKGROUND

• Kinoshita Y, Kuratsukuri K, Landas S, Imaida K, Rovito PM Jr, Wang CY, Haas GP. Expression of prostate-specific membrane antigen in normal and malignant human tissues. World J Surg. 2006 Apr;30(4):628-36. doi: 10.1007/s00268-005-0544-5.

  PMID: 16555021 BACKGROUND

• Krause BJ, Souvatzoglou M, Tuncel M, Herrmann K, Buck AK, Praus C, Schuster T, Geinitz H, Treiber U, Schwaiger M. The detection rate of [11C]choline-PET/CT depends on the serum PSA-value in patients with biochemical recurrence of prostate cancer. Eur J Nucl Med Mol Imaging. 2008 Jan;35(1):18-23. doi: 10.1007/s00259-007-0581-4. Epub 2007 Sep 22.

  PMID: 17891394 BACKGROUND

• Li X, Rowe SP, Leal JP, Gorin MA, Allaf ME, Ross AE, Pienta KJ, Lodge MA, Pomper MG. Semiquantitative Parameters in PSMA-Targeted PET Imaging with 18F-DCFPyL: Variability in Normal-Organ Uptake. J Nucl Med. 2017 Jun;58(6):942-946. doi: 10.2967/jnumed.116.179739. Epub 2016 Dec 8.

  PMID: 27932557 BACKGROUND

• Mena E, Lindenberg ML, Turkbey IB, Shih JH, Harmon SA, Lim I, Lin F, Adler S, Eclarinal P, McKinney YL, Citrin D, Dahut W, Wood BJ, Krishnasamy V, Chang R, Levy E, Merino M, Pinto P, Eary JF, Choyke PL. 18F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy. J Nucl Med. 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.

  PMID: 31676732 BACKGROUND

• Morris MJ, Rowe SP, Gorin MA, Saperstein L, Pouliot F, Josephson D, Wong JYC, Pantel AR, Cho SY, Gage KL, Piert M, Iagaru A, Pollard JH, Wong V, Jensen J, Lin T, Stambler N, Carroll PR, Siegel BA; CONDOR Study Group. Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study. Clin Cancer Res. 2021 Jul 1;27(13):3674-3682. doi: 10.1158/1078-0432.CCR-20-4573. Epub 2021 Feb 23.

  PMID: 33622706 BACKGROUND

• Nanni C, Zanoni L, Pultrone C, Schiavina R, Brunocilla E, Lodi F, Malizia C, Ferrari M, Rigatti P, Fonti C, Martorana G, Fanti S. (18)F-FACBC (anti1-amino-3-(18)F-fluorocyclobutane-1-carboxylic acid) versus (11)C-choline PET/CT in prostate cancer relapse: results of a prospective trial. Eur J Nucl Med Mol Imaging. 2016 Aug;43(9):1601-10. doi: 10.1007/s00259-016-3329-1. Epub 2016 Mar 10.

  PMID: 26960562 BACKGROUND

• Nunez R, Macapinlac HA, Yeung HW, Akhurst T, Cai S, Osman I, Gonen M, Riedel E, Scher HI, Larson SM. Combined 18F-FDG and 11C-methionine PET scans in patients with newly progressive metastatic prostate cancer. J Nucl Med. 2002 Jan;43(1):46-55.

  PMID: 11801702 BACKGROUND

• Odewole OA, Tade FI, Nieh PT, Savir-Baruch B, Jani AB, Master VA, Rossi PJ, Halkar RK, Osunkoya AO, Akin-Akintayo O, Zhang C, Chen Z, Goodman MM, Schuster DM. Recurrent prostate cancer detection with anti-3-[(18)F]FACBC PET/CT: comparison with CT. Eur J Nucl Med Mol Imaging. 2016 Sep;43(10):1773-83. doi: 10.1007/s00259-016-3383-8. Epub 2016 Apr 18.

  PMID: 27091135 BACKGROUND

• Perner S, Hofer MD, Kim R, Shah RB, Li H, Moller P, Hautmann RE, Gschwend JE, Kuefer R, Rubin MA. Prostate-specific membrane antigen expression as a predictor of prostate cancer progression. Hum Pathol. 2007 May;38(5):696-701. doi: 10.1016/j.humpath.2006.11.012. Epub 2007 Feb 22.

  PMID: 17320151 BACKGROUND

• Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20. doi: 10.1056/NEJMoa041318.

  PMID: 15470214 BACKGROUND

• Pfister D, Porres D, Heidenreich A, Heidegger I, Knuechel R, Steib F, Behrendt FF, Verburg FA. Detection of recurrent prostate cancer lesions before salvage lymphadenectomy is more accurate with (68)Ga-PSMA-HBED-CC than with (18)F-Fluoroethylcholine PET/CT. Eur J Nucl Med Mol Imaging. 2016 Jul;43(8):1410-7. doi: 10.1007/s00259-016-3366-9. Epub 2016 Mar 19.

  PMID: 26993315 BACKGROUND

• Pienta KJ, Gorin MA, Rowe SP, Carroll PR, Pouliot F, Probst S, Saperstein L, Preston MA, Alva AS, Patnaik A, Durack JC, Stambler N, Lin T, Jensen J, Wong V, Siegel BA, Morris MJ. A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY). J Urol. 2021 Jul;206(1):52-61. doi: 10.1097/JU.0000000000001698. Epub 2021 Feb 26.

  PMID: 33634707 BACKGROUND

• Pinto JT, Suffoletto BP, Berzin TM, Qiao CH, Lin S, Tong WP, May F, Mukherjee B, Heston WD. Prostate-specific membrane antigen: a novel folate hydrolase in human prostatic carcinoma cells. Clin Cancer Res. 1996 Sep;2(9):1445-51.

  PMID: 9816319 BACKGROUND

• Pound CR, Partin AW, Eisenberger MA, Chan DW, Pearson JD, Walsh PC. Natural history of progression after PSA elevation following radical prostatectomy. JAMA. 1999 May 5;281(17):1591-7. doi: 10.1001/jama.281.17.1591.

  PMID: 10235151 BACKGROUND

• Pucar D, Sella T, Schoder H. The role of imaging in the detection of prostate cancer local recurrence after radiation therapy and surgery. Curr Opin Urol. 2008 Jan;18(1):87-97. doi: 10.1097/MOU.0b013e3282f13ac3.

  PMID: 18090496 BACKGROUND

• Reinfelder J, Kuwert T, Beck M, Sanders JC, Ritt P, Schmidkonz C, Hennig P, Prante O, Uder M, Wullich B, Goebell P. First Experience With SPECT/CT Using a 99mTc-Labeled Inhibitor for Prostate-Specific Membrane Antigen in Patients With Biochemical Recurrence of Prostate Cancer. Clin Nucl Med. 2017 Jan;42(1):26-33. doi: 10.1097/RLU.0000000000001433.

  PMID: 27775936 BACKGROUND

• Rinnab L, Mottaghy FM, Blumstein NM, Reske SN, Hautmann RE, Hohl K, Moller P, Wiegel T, Kuefer R, Gschwend JE. Evaluation of [11C]-choline positron-emission/computed tomography in patients with increasing prostate-specific antigen levels after primary treatment for prostate cancer. BJU Int. 2007 Oct;100(4):786-93. doi: 10.1111/j.1464-410X.2007.07083.x.

  PMID: 17822459 BACKGROUND

• Rowe SP, Macura KJ, Mena E, Blackford AL, Nadal R, Antonarakis ES, Eisenberger M, Carducci M, Fan H, Dannals RF, Chen Y, Mease RC, Szabo Z, Pomper MG, Cho SY. PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Mol Imaging Biol. 2016 Jun;18(3):411-9. doi: 10.1007/s11307-016-0957-6.

  PMID: 27080322 BACKGROUND

• Rowe SP, Pienta KJ, Pomper MG, Gorin MA. PSMA-RADS Version 1.0: A Step Towards Standardizing the Interpretation and Reporting of PSMA-targeted PET Imaging Studies. Eur Urol. 2018 Apr;73(4):485-487. doi: 10.1016/j.eururo.2017.10.027. Epub 2017 Nov 11.

  PMID: 29132714 BACKGROUND

• Scattoni V, Picchio M, Suardi N, Messa C, Freschi M, Roscigno M, Da Pozzo L, Bocciardi A, Rigatti P, Fazio F. Detection of lymph-node metastases with integrated [11C]choline PET/CT in patients with PSA failure after radical retropubic prostatectomy: results confirmed by open pelvic-retroperitoneal lymphadenectomy. Eur Urol. 2007 Aug;52(2):423-9. doi: 10.1016/j.eururo.2007.03.032. Epub 2007 Mar 20.

  PMID: 17397992 BACKGROUND

• Scheidler J, Hricak H, Vigneron DB, Yu KK, Sokolov DL, Huang LR, Zaloudek CJ, Nelson SJ, Carroll PR, Kurhanewicz J. Prostate cancer: localization with three-dimensional proton MR spectroscopic imaging--clinicopathologic study. Radiology. 1999 Nov;213(2):473-80. doi: 10.1148/radiology.213.2.r99nv23473.

  PMID: 10551229 BACKGROUND

• Schuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19.

  PMID: 24144687 BACKGROUND

• Schuster DM, Votaw JR, Nieh PT, Yu W, Nye JA, Master V, Bowman FD, Issa MM, Goodman MM. Initial experience with the radiotracer anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid with PET/CT in prostate carcinoma. J Nucl Med. 2007 Jan;48(1):56-63.

  PMID: 17204699 BACKGROUND

• Shreve PD, Grossman HB, Gross MD, Wahl RL. Metastatic prostate cancer: initial findings of PET with 2-deoxy-2-[F-18]fluoro-D-glucose. Radiology. 1996 Jun;199(3):751-6. doi: 10.1148/radiology.199.3.8638000.

  PMID: 8638000 BACKGROUND

• Silver DA, Pellicer I, Fair WR, Heston WD, Cordon-Cardo C. Prostate-specific membrane antigen expression in normal and malignant human tissues. Clin Cancer Res. 1997 Jan;3(1):81-5.

  PMID: 9815541 BACKGROUND

• Smith-Jones PM, Vallabahajosula S, Goldsmith SJ, Navarro V, Hunter CJ, Bastidas D, Bander NH. In vitro characterization of radiolabeled monoclonal antibodies specific for the extracellular domain of prostate-specific membrane antigen. Cancer Res. 2000 Sep 15;60(18):5237-43.

  PMID: 11016653 BACKGROUND

• Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.

  PMID: 15470213 BACKGROUND

• 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.

  PMID: 23707439 BACKGROUND

• Treglia G, Ceriani L, Sadeghi R, Giovacchini G, Giovanella L. Relationship between prostate-specific antigen kinetics and detection rate of radiolabelled choline PET/CT in restaging prostate cancer patients: a meta-analysis. Clin Chem Lab Med. 2014 May;52(5):725-33. doi: 10.1515/cclm-2013-0675.

  PMID: 24310773 BACKGROUND

• Troyer JK, Beckett ML, Wright GL Jr. Detection and characterization of the prostate-specific membrane antigen (PSMA) in tissue extracts and body fluids. Int J Cancer. 1995 Sep 4;62(5):552-8. doi: 10.1002/ijc.2910620511.

  PMID: 7665226 BACKGROUND

• Wondergem M, van der Zant FM, Knol RJJ, Lazarenko SV, Pruim J, de Jong IJ. 18F-DCFPyL PET/CT in the Detection of Prostate Cancer at 60 and 120 Minutes: Detection Rate, Image Quality, Activity Kinetics, and Biodistribution. J Nucl Med. 2017 Nov;58(11):1797-1804. doi: 10.2967/jnumed.117.192658. Epub 2017 Apr 27.

  PMID: 28450569 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jae Young Joung, Ph.D

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 10, 2023
• Study Start: May 8, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)