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

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.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

1. Histological confirmation of prostate malignancy
2. Patient must have had their primary PCa treated with surgery and/or radiation therapy; salvage radiation to the prostate bed or pelvis is allowed
3. Patient must be ≥ 18 years of age
4. Patient must have an Eastern Cooperative Oncology Group performance status ≤ 2
5. 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
6. Absence of any of the exclusion criteria
7. Signed informed consent

Exclusion Criteria:

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

• BACKGROUNDGalgano 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
• RESULTAfshar-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
• RESULTAfshar-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
• RESULTBauman 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
• RESULTBeheshti 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
• RESULTCastellucci 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.