A Study on PET/CT Imaging (scan) with 18F-DCFPyL (radioactive substance) of Prostate Cancer having recurred shown by increase in PSA blood level

Phase 1

• Conditions: Patients with histopathologically confirmed prostate adenocarcinoma per original diagnosis and subsequent definitive therapy, with first biochemical recurrence; MedDRA version: 21.0Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000121-37-NL
• Lead Sponsor: Curium PET France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-09
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 217

Inclusion Criteria

1. Male.
2. Age superior or equal to 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 174

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT;Secondary Objective: Impact on patient treatment/management.<br>Per-region detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT.<br>Sensitivity and specificity of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT on a per-patient and per-region basis, using a composite SOR.<br>Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for regions using a composite SOR.<br>Safety of 18F-DCFPyL versus that of 18F-FCH<br>;Primary end point(s): Per-patient detection rate of 18F-DCFPyL PET/CT and 18F-FCH PET/CT for recurrence (either local, regional or distant), based on the independent central reading. The detection rate is defined as the ratio between the number of patients defined as positive at patient level by at least 2 independent readers, and the total number of assessed patients.;Timepoint(s) of evaluation of this end point: Last patient last tracer injection