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

NCT04734184 | Unknown Phase 3 DMC

• 1 other identifier: 2020-000121-37
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

PYTHON is designed to establish the efficacy and safety of 18F-DCFPyL in comparison with that of 18F-fluorocholine, in patients with first biochemical recurrence (BCR) after initial definitive therapy (prostatectomy, external beam radiotherapy or brachytherapy) for histopathologically confirmed prostate adenocarcinoma per original diagnosis. PET/CT scans will be each interpreted by three independent masked experts who are not otherwise involved in the trial.

Conditions

Prostate Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• to compare per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT.

  10 weeks

Interventions

DCFPyL DIAGNOSTIC_TEST

Single dose injection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male.
• Age min 18 years.
• Histopathological proven prostate adenocarcinoma per original diagnosis.
• 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.
• Able and willing to provide informed consent and comply with protocol requirements
• Patient who can undergo all study procedures per Investigator's point of view
• Patient with social insurance cover.

You may not qualify if:

• Patients displaying any of the following criteria will not be included:
• ECOG \> 2
• History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection)
• History of adjuvant radiotherapy
• History of cryotherapy, high-intensity focused ultrasound (HIFU)
• Other active malignant tumour
• Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or ongoing
• Treatment with colchicine in the past 8 days or ongoing
• Treatment with hematopoietic colony stimulating factors (CSF) in the past 5 days or ongoing
• Unable to lie supine for imaging
• Known allergy to investigational or reference products or to any excipients
• Unable to provide written consent (linguistic or psychological inability)
• Uncooperative, in the Investigator's opinion.
• Subjects deprived of their freedom by administrative or legal decision or who are under guardianship

Sponsors & Collaborators

• Curium PET France: lead

Study Sites (1)

CURIUM PET France

Saint-Beauzire, 63360, France

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: July 7, 2020
• Primary Completion: May 1, 2021
• Study Completion: February 1, 2022
• Last Updated: February 2, 2021

Record last verified: 2021-02

Locations

FR (1)