A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer

Phase 3

Completed

• Conditions: 10014713; Biochemical recurrent prostate cancer; prostate cancer

• Registration Number: NL-OMON55231
• Lead Sponsor: Curium PET France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Male.
2. Age * 18 years.
3. Histopathological proven prostate adenocarcinoma per original diagnosis.
4. First suspected recurrence of prostate cancer based on rising
prostate-specific antigen (PSA) after initial curative therapy with radical
prostatectomy of PSA * 0.2 ng/mL confirmed by a subsequent PSA value of *0.2
ng/mL or with radiation therapy (external beam or brachytherapy) of PSA > 2
ng/mL above the nadir after therapy regardless of the serum concentration of
the nadir.
5. Able and willing to provide informed consent and comply with protocol
requirements
6. Patient who can undergo all study procedures per Investigator*s point of
view
7. Patient with social insurance cover.

Exclusion Criteria

1. ECOG > 2
2. History of previous salvage therapies (including salvage radiotherapy or
salvage lymph node dissection)
3. History of adjuvant radiotherapy
4. History of cryotherapy, high-intensity focused ultrasound (HIFU)
5. Other active malignant tumour
6. Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or
ongoing
7. Treatment with colchicine in the past 8 days or ongoing
8. Treatment with hematopoietic colony stimulating factors (CSF) in the past 5
days or ongoing
9. Unable to lie supine for imaging
10. Known allergy to investigational or reference products or to any excipients
11. Unable to provide written consent (linguistic or psychological inability)
12. Participation in another clinical study within one month prior to inclusion
13. Uncooperative, in the Investigator's opinion.
14. Subjects deprived of their freedom by administrative or legal decision or
who are under guardianship

Study & Design

• Study Type: Interventional
• Study Design: Not specified