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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ITEL Telecomunicazioni Srl
• Collaborator: Advice Pharma Group srl
• Treatments: 18F-JK-PSMA-7; Radiopharmaceuticals

Criteria

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