Prospective Comparative Study for Patients With Biochemical Recurrence Prostate Cancer Detecting by 18F-JK-PSMA-7

NCT05622162 | Active Not Recruiting Phase 3

• 1 other identifier: EudraCT 2021-005993-24
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

The present study in patients with Prostate cancer and biochemical failure after surgery and/or radical-postoperative Radio Therapy (RT) will evaluate if PET/CT with 18F-JK-PSMA-7 compared to PET-CT 18F-Choline is able to identify the early pattern of biochemical recurrence and/or metastatic sites, so that the patient could be better managed, with a benefit in survival.

Conditions

Prostate Cancer; 18F- Fluorocholine; PSMA PET; Radiotherapy; Prostatectomy; Tumor of Prostate

Keywords

Prostate Cancer; Prostatectomy; diagnostic radiopharmaceutical; PET; CT; PSA; Biochemical Recurrence; 18F- Fluorocholine; 18F-JK-PSMA-7; PSMA; Standard of truth

Outcome Measures

Primary Outcomes (1)

• Detection rate of 18F-JK-PSMA-7 PET/CT

  To evaluate the diagnostic accuracy of 18F-JK-PSMA-7 versus 18F- Fluorocholine even for low PSA levels, where the 18F- Fluorocholine is considered to be insensitive in these conditions. Hypothesis: a 20% diagnostic superiority of 18F-JK-PSMA-7 versus 18F- Fluorocholine.

  1 Months

Secondary Outcomes (5)

• Evaluation of the safety profile of 18F-JK-PSMA-7

  6 months

• Evaluation of the discordance rate between IMP and Comparator

  1 month

• Influence of 18F-JK-PSMA-7 in the therapeutic management decision

  6 months

• Evaluation of sensitivity of 18F-JK-PSMA-7

  6 months

• Evaluation of specificity of 18F-JK-PSMA-7

  6 months

Study Arms (1)

Interventional and Comparator

EXPERIMENTAL

The subject participation in the study consists from performing of one non-contrast enhanced PET/CT with Investigational Product (18F-JK-PSMA-7) and of one PET/CT with Comparator (18F-Fluorocholine) This sequence of administration is established in advance as the organizational model, linked to the availability and management of the radiopharmaceutical, not allow to perform a randomization.

Drug: Radiopharmaceutical 18F-JK-PSMA-7; Drug: Radiopharmaceutical 18F-Fluorocholine

Interventions

Radiopharmaceutical 18F-JK-PSMA-7 DRUG

The Investigational product 18F-JK-PSMA-7 is a diagnostic radiopharmaceutical for use with positron emission tomography. 18F-JK-PSMA-7 is administered as direct intravenous injection. One single administration of 2-4 MBq/kg of 18F-JK-PSMA-7 is scheduled in each patient included in this study.

Also known as: 18F-JK-PSMA-7

Interventional and Comparator

Radiopharmaceutical 18F-Fluorocholine DRUG

The active substance of Comparator is 18F-Fluorocholine. The Comparator will be a 18F-Fluorocholine with a Marketing Authorisation in Italy that will be used in compliance with its Summary of Product Characteristics (SmPC). 18F-Fluorocholine is administrated as direct intravenous injection. One single administration of 18F-Fluorocholine is scheduled in each patient included in this study.

Also known as: 18F-Fluorocholine

Interventional and Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of prostate malignancy
• Patient must have had their primary PCa treated with surgery and/or radiation therapy; salvage radiation to the prostate bed or pelvis is allowed
• Patient must be ≥ 18 years of age
• Patient must have an Eastern Cooperative Oncology Group performance status ≤ 2
• For patients treated with radical prostatectomy: arise of PSA ≥ 0.2 ng/mL (performed in the last month) or a rise of 2 ng/mL or more above the nadir PSA after definitive radiation therapy defined by two subsequent PSA assessments performed over a 3-month period in the same laboratory

You may not qualify if:

• Signed informed consent
• More than 3 years of androgen deprivation therapy (ADT), with less than 3 months from the last treatment
• Spinal cord compression or impending spinal cord compression
• Receipt of any other investigational agents in the previous 3 months
• Inability to lie flat during or tolerate PET/CT
• Hypersensitivity to active substance or any of excipients of Investigational Medicinal Product or Comparator
• Life expectancy \<6 months
• ECOG performance status \>2
• Refusal to sign informed consent
• Participation in a concurrent clinical trial
• Concomitant active malignancy
• Subject deprived of its freedom by administrative or legal decision or who is under guardianship

Sponsors & Collaborators

• ITEL Telecomunicazioni Srl: lead
• Advice Pharma Group srl: collaborator

Study Sites (2)

I.R.S.T. Srl Irccs

Meldola, Forlì-Cesena, Italy

Location

Ospedale Classificato Sacro Cuore - Don Calabria

Negrar, Verona, Italy

Location

Related Publications (25)

• Galgano SJ, Valentin R, McConathy J. Role of PET imaging for biochemical recurrence following primary treatment for prostate cancer. Transl Androl Urol. 2018 Sep;7(Suppl 4):S462-S476. doi: 10.21037/tau.2018.06.09.

  PMID: 30363475 BACKGROUND

• Afshar-Oromieh A, Avtzi E, Giesel FL, Holland-Letz T, Linhart HG, Eder M, Eisenhut M, Boxler S, Hadaschik BA, Kratochwil C, Weichert W, Kopka K, Debus J, Haberkorn U. The diagnostic value of PET/CT imaging with the (68)Ga-labelled PSMA ligand HBED-CC in the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2015 Feb;42(2):197-209. doi: 10.1007/s00259-014-2949-6. Epub 2014 Nov 20.

  PMID: 25411132 RESULT

• Afshar-Oromieh A, Zechmann CM, Malcher A, Eder M, Eisenhut M, Linhart HG, Holland-Letz T, Hadaschik BA, Giesel FL, Debus J, Haberkorn U. Comparison of PET imaging with a (68)Ga-labelled PSMA ligand and (18)F-choline-based PET/CT for the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2014 Jan;41(1):11-20. doi: 10.1007/s00259-013-2525-5. Epub 2013 Sep 27.

  PMID: 24072344 RESULT

• Bauman G, Belhocine T, Kovacs M, Ward A, Beheshti M, Rachinsky I. 18F-fluorocholine for prostate cancer imaging: a systematic review of the literature. Prostate Cancer Prostatic Dis. 2012 Mar;15(1):45-55. doi: 10.1038/pcan.2011.35. Epub 2011 Aug 16.

  PMID: 21844889 RESULT

• Beheshti M, Haim S, Zakavi R, Steinmair M, Waldenberger P, Kunit T, Nader M, Langsteger W, Loidl W. Impact of 18F-choline PET/CT in prostate cancer patients with biochemical recurrence: influence of androgen deprivation therapy and correlation with PSA kinetics. J Nucl Med. 2013 Jun;54(6):833-40. doi: 10.2967/jnumed.112.110148. Epub 2013 Apr 4.

  PMID: 23559588 RESULT

• Castellucci P, Fanti S. Prostate cancer: Identifying sites of recurrence with choline-PET-CT imaging. Nat Rev Urol. 2015 Mar;12(3):134-5. doi: 10.1038/nrurol.2014.321. Epub 2014 Dec 2. No abstract available.

  PMID: 25447835 RESULT

• Decaestecker K, De Meerleer G, Lambert B, Delrue L, Fonteyne V, Claeys T, De Vos F, Huysse W, Hautekiet A, Maes G, Ost P. Repeated stereotactic body radiotherapy for oligometastatic prostate cancer recurrence. Radiat Oncol. 2014 Jun 12;9:135. doi: 10.1186/1748-717X-9-135.

  PMID: 24920079 RESULT

• Dietlein F, Hohberg M, Kobe C, Zlatopolskiy BD, Krapf P, Endepols H, Tager P, Hammes J, Heidenreich A, Neumaier B, Drzezga A, Dietlein M. An 18F-Labeled PSMA Ligand for PET/CT of Prostate Cancer: First-in-Humans Observational Study and Clinical Experience with 18F-JK-PSMA-7 During the First Year of Application. J Nucl Med. 2020 Feb;61(2):202-209. doi: 10.2967/jnumed.119.229542. Epub 2019 Jul 19.

  PMID: 31324713 RESULT

• Eiber M, Kroenke M, Wurzer A, Ulbrich L, Jooss L, Maurer T, Horn T, Schiller K, Langbein T, Buschner G, Wester HJ, Weber W. 18F-rhPSMA-7 PET for the Detection of Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. J Nucl Med. 2020 May;61(5):696-701. doi: 10.2967/jnumed.119.234914. Epub 2019 Dec 13.

  PMID: 31836682 RESULT

• Fuccio C, Rubello D, Castellucci P, Marzola MC, Fanti S. Choline PET/CT for prostate cancer: main clinical applications. Eur J Radiol. 2011 Nov;80(2):e50-6. doi: 10.1016/j.ejrad.2010.07.023. Epub 2010 Aug 25.

  PMID: 20800404 RESULT

• Giovacchini G, Giovannini E, Borso E, Lazzeri P, Riondato M, Leoncini R, Duce V, Conti E, Picchio M, Ciarmiello A. Sensitivity of fluorine-18-fluoromethylcholine PET/CT to prostate-specific antigen over different plasma levels: a retrospective study in a cohort of 192 patients with prostate cancer. Nucl Med Commun. 2019 Mar;40(3):258-263. doi: 10.1097/MNM.0000000000000959.

  PMID: 30507748 RESULT

• Heidenreich A, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N; European Association of Urology. EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Eur Urol. 2014 Jan;65(1):124-37. doi: 10.1016/j.eururo.2013.09.046. Epub 2013 Oct 6.

  PMID: 24207135 RESULT

• Kroenke M, Wurzer A, Schwamborn K, Ulbrich L, Jooss L, Maurer T, Horn T, Rauscher I, Haller B, Herz M, Wester HJ, Weber WA, Eiber M. Histologically Confirmed Diagnostic Efficacy of 18F-rhPSMA-7 PET for N-Staging of Patients with Primary High-Risk Prostate Cancer. J Nucl Med. 2020 May;61(5):710-715. doi: 10.2967/jnumed.119.234906. Epub 2019 Dec 13.

  PMID: 31836681 RESULT

• Mamede M, Ceci F, Castellucci P, Schiavina R, Fuccio C, Nanni C, Brunocilla E, Fantini L, Costa S, Ferretti A, Colletti PM, Rubello D, Fanti S. The role of 11C-choline PET imaging in the early detection of recurrence in surgically treated prostate cancer patients with very low PSA level <0.5 ng/mL. Clin Nucl Med. 2013 Sep;38(9):e342-5. doi: 10.1097/RLU.0b013e31829af913.

  PMID: 23797218 RESULT

• Menard C, Iupati D, Publicover J, Lee J, Abed J, O'Leary G, Simeonov A, Foltz WD, Milosevic M, Catton C, Morton G, Bristow R, Bayley A, Atenafu EG, Evans AJ, Jaffray DA, Chung P, Brock KK, Haider MA. MR-guided prostate biopsy for planning of focal salvage after radiation therapy. Radiology. 2015 Jan;274(1):181-91. doi: 10.1148/radiol.14122681. Epub 2014 Sep 8.

  PMID: 25203127 RESULT

• Natarajan A, Agrawal A, Murthy V, Bakshi G, Joshi A, Purandare N, Shah S, Puranik A, Rangarajan V. Initial experience of Ga-68 prostate-specific membrane antigen positron emission tomography/computed tomography imaging in evaluation of biochemical recurrence in prostate cancer patients. World J Nucl Med. 2019 Jul-Sep;18(3):244-250. doi: 10.4103/wjnm.WJNM_47_18.

  PMID: 31516367 RESULT

• Grummet J, Eggener S. Re: NCCN Prostate Cancer Guidelines Version 1.2022 - September 10, 2021. Eur Urol. 2022 Feb;81(2):218. doi: 10.1016/j.eururo.2021.11.025. Epub 2021 Dec 9. No abstract available.

  PMID: 34895925 RESULT

• Oh SW, Cheon GJ. Prostate-Specific Membrane Antigen PET Imaging in Prostate Cancer: Opportunities and Challenges. Korean J Radiol. 2018 Sep-Oct;19(5):819-831. doi: 10.3348/kjr.2018.19.5.819. Epub 2018 Aug 6.

  PMID: 30174470 RESULT

• Perera M, Papa N, Christidis D, Wetherell D, Hofman MS, Murphy DG, Bolton D, Lawrentschuk N. Sensitivity, Specificity, and Predictors of Positive 68Ga-Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2016 Dec;70(6):926-937. doi: 10.1016/j.eururo.2016.06.021. Epub 2016 Jun 28.

  PMID: 27363387 RESULT

• Perks J, Benedict S. MO-F-BRCD-02: SBRT (Part 2): Physics and Quality Assurance Updates. Med Phys. 2012 Jun;39(6Part21):3873. doi: 10.1118/1.4735813.

  PMID: 28518227 RESULT

• Rahbar K, Afshar-Oromieh A, Seifert R, Wagner S, Schafers M, Bogemann M, Weckesser M. Diagnostic performance of 18F-PSMA-1007 PET/CT in patients with biochemical recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2018 Nov;45(12):2055-2061. doi: 10.1007/s00259-018-4089-x. Epub 2018 Jul 20.

  PMID: 30027419 RESULT

• Rajasekaran AK, Anilkumar G, Christiansen JJ. Is prostate-specific membrane antigen a multifunctional protein? Am J Physiol Cell Physiol. 2005 May;288(5):C975-81. doi: 10.1152/ajpcell.00506.2004.

  PMID: 15840561 RESULT

• Samper Ots P, Luis Cardo A, Vallejo Ocana C, Cabeza Rodriguez MA, Glaria Enriquez LA, Couselo Paniagua ML, Olivera Vegas J. Diagnostic performance of 18F-choline PET-CT in prostate cancer. Clin Transl Oncol. 2019 Jun;21(6):766-773. doi: 10.1007/s12094-018-1985-2. Epub 2018 Nov 17.

  PMID: 30448957 RESULT

• Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.

  PMID: 21350618 RESULT

• Zlatopolskiy BD, Endepols H, Krapf P, Guliyev M, Urusova EA, Richarz R, Hohberg M, Dietlein M, Drzezga A, Neumaier B. Discovery of 18F-JK-PSMA-7, a PET Probe for the Detection of Small PSMA-Positive Lesions. J Nucl Med. 2019 Jun;60(6):817-823. doi: 10.2967/jnumed.118.218495. Epub 2018 Nov 2.

  PMID: 30389823 RESULT

Related Links

• Farmacopea Europea X edizione

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

18F-JK-PSMA-7; fluorocholine

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: The blind readers of PET/CT examinations with Investigational product (18F-JK-PSMA-7) and with Comparator (18F-fluorocholine) will be blinded to any clinical data of patient. The analysis of images obtained with IMP (18F-JK-PSMA-7) and with Comparator (18F-fluorocholine) will be performed by two independent off-site experts blinded to any patient´s clinical data, using the defined grid (Appendix I). Discrepancies between results of the two observers will be recorded by the clinical manager and a consensus reading with third expert will be organized. This reading will be used for determination of imaging performances. Wash-out period of at least one month is ensured between reading of examinations with Investigational product (18F-JK-PSMA-7) and with Comparator (18F-Fluorocholine) for each blind reader.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicentric, comparative (controlled), phase III study of diagnostic performance with blind reading and standard of truth.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 18, 2022
• Study Start: December 19, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)