Phase III Multicentre Prospective Comparative Study of Detection Rate of 18F-JK-PSMA-7 and of 18F-fluorocholine in Patients With Biochemical Recurrence of Prostate Cancer After Previous Treatment With Curative Intent (MIP7)

NCT05622162 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	ITEL Telecomunicazioni Srl
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	106
Start date	2022-12-19
Completion	2024-06

Conditions

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

Interventions

• Radiopharmaceutical 18F-JK-PSMA-7
• Radiopharmaceutical 18F-Fluorocholine

Primary outcomes

• Detection rate of 18F-JK-PSMA-7 PET/CT — 1 Months
  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.

Countries

Italy