F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer (PROPER-ABX)

January 23, 2020 updated by: Radboud University Medical Center

F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer, Comparison With 18F-Fluciclovine

18F-PSMA-1007 is a new radiopharmaceutical for the detection of prostate cancer with potential benefits over the registered 18F-Fluciclovine (Axumin). The main potential benefit is the higher detection rate of PSMA compared to Fluciclovin in the low PSA range. It may therefore be more sensitive in detecting local disease in case of biochemical recurrens. The investigators aim to compare the detection efficacy of 18F-PSMA-1007 to 18F-Fluciclovin in prostate cancer patients with biochemical recurrence (PSA levels 0.2-5 ng/ml).

Study Overview

Detailed Description

Rationale: 18F-PSMA-1007 is a new radiopharmaceutical for detection of prostate cancer with potential benefits over 18F-Fluciclovine, such as higher detection rates at low PSA levels and small lesions, lower bone marrow uptake and higher tumour-background ratio. Therefore, 18F-PSMA-1007 PET may be more sensitive in detecting local recurrence and metastases of prostate cancer. However, Fluciclovine is a registered tracer, whereas PSMA-1007 is not registered, and therefore there is pressure to use fluciclovine instead of PSMA-1007. Therefore more comparative data are urgently needed.

Objective: Main objective is to compare detection efficacy of 18F-PSMA-1007 PET-CT to 18F-Fluciclovine, in patients with early biochemical recurrence of prostate cancer.

Study design: Comparative phase II diagnostic study Study population: 50 males >18 years, with biochemical recurrence of prostate cancer and PSA-levels between 0.2-5.0 ng/mL. About 25 of the patients must have PSA-levels between 0.2-1.0 ng/mL. Contra-indications: claustrophobia, inability to lay still for the duration of the exam. Already established local recurrence in the prostate is not a contra-indication for study participation.

Intervention: 50 patients who already were referred by their treating physician for PET/CT will receive both an 18F-PSMA-1007 PET-CT (90 minutes post injection) and an 18F-Fluciclovine PET-CT (<15 minutes post injection). Injected dose of the 18F-PSMA-1007 will be 4 MBq/kg ±10%. The injected dose of 18F-Fluciclovine is 370 MBq ±10%.

Analysis: A clinical report is made of both the 18F-PSMA-1007 PET-CT scan and 18F-Fluciclovine PET-CT scan. For further analysis in the study all data will be anonymized, and will be blindly scored by two nuclear medicine physicians. The number of PET-positive lesions (judged to be prostate cancer, of course PET positive lesions referring to different processes like inflammation will not be taken intob account, this is oart of the PET-reading process) per area are separately scored for both tracers. Lesions will be scored on a 5-point scale ranging from most probably benign to most probably malignant. Follow-up data of the patients, to determine the eventual outcome, will be extracted from their medical file. An expert panel will eventually decide which lesions are considered to be metastases using all available follow-up data.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males ≥ 18 years
  • Histologically proven adenocarcinoma of the prostate
  • Prior local treatment with curative intent
  • Biochemical recurrence with (rising) PSA-levels of 0.2-5.0 ug/L
  • Referred by urologist for PET/CT for localization of the recurrence
  • PSA level determined <8 weeks before study participation
  • Willing to sign informed consent

Exclusion Criteria:

  • Contra-indications for PET-CT: claustrophobia or inability to lay still for the duration of the exam.
  • Other cancer <2 years prior to biochemical recurrence of prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-PSMA PET/CT and 18F-Fluciclovin PET/CT
patients undergo an 18F-PSMA PET/CT scan and an 18F-Fluciclovin PET/CT scan, within a time frame of two weeks.
370 MBq ±10% 18F-Fluciclovin + low-dose CT scan, from skull base to pelvis.
Other Names:
  • Axumin scan
4 MBq/kg ±10% F18-PSMA + low-dose CT scan, from skull base to pelvis
Other Names:
  • PSMA scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection efficacy of the two PET-tracers on a per patient level
Time Frame: Follow-up duration is 6 months.
Comparisson of number of patients with a positive scan
Follow-up duration is 6 months.
Detection efficacy of the two PET-tracers on a per lesion level
Time Frame: Follow-up duration is 6 months.
Comparisson of number of positive lesions
Follow-up duration is 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative analysis
Time Frame: 6 months
tumour background ratio, SUV (of tumor and normal organs)
6 months
Comparing specificity
Time Frame: 6 months
where the reference is consensus by the expert panel using all available information including 6 months follow up data (PSA-values; absolute and doublind time, pathology reports of suspected prostate cancer lesions, prostate-cancer targeted imaging by PET CT, MRI, CT or bone scan).
6 months
Sensitivity per area, local recurrence
Time Frame: 6 months
local recurrence, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
6 months
Sensitivity per area, locoregional lymph nodes
Time Frame: 6 months
locoregional lymph nodes, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
6 months
Sensitivity per area, distant lymph nodes
Time Frame: 6 months
Distant lymph nodes, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
6 months
Sensitivity per area, bone metastases
Time Frame: 6 months
Bone metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
6 months
Sensitivity per area, extraskeletal organ metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.
Time Frame: 6 months
Extraskeletal organ metastases
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: James Nagarajah, MD, PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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