F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer

NCT ID: NCT04239742

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2023-01-31

Brief Summary

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).

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.

Conditions

Prostate Cancer Recurrent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

F18-fluciclovine PET/CT

Intervention Type: DIAGNOSTIC_TEST

370 MBq ±10% 18F-Fluciclovin + low-dose CT scan, from skull base to pelvis.

F18-PSMA-1007 PET/CT

Intervention Type: DIAGNOSTIC_TEST

4 MBq/kg ±10% F18-PSMA + low-dose CT scan, from skull base to pelvis

Interventions

F18-fluciclovine PET/CT

370 MBq ±10% 18F-Fluciclovin + low-dose CT scan, from skull base to pelvis.

Intervention Type: DIAGNOSTIC_TEST

F18-PSMA-1007 PET/CT

4 MBq/kg ±10% F18-PSMA + low-dose CT scan, from skull base to pelvis

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Axumin scan; PSMA scan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ABX advanced biochemical compounds GmbH

INDUSTRY

Sponsor Role: collaborator

Radboud Translational Medicine

UNKNOWN

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Nagarajah, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboudumc

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Willemijn van Gemert, MD, PhD

Role: CONTACT

willemijn.vangemert@radboudumc.nl

0031243614510

James Nagarajah, MD, PhD

Role: CONTACT

James.nagarajah@radboudumc.nl

0031243614510

Facility Contacts

Willemijn van Gemert, MD, PhD

Role: primary

willemijn.vangemert@radboudumc.nl

0243614510

References

Loeff CC, van Gemert W, Prive BM, van Oort IM, Hermsen R, Somford DM, Nagarajah J, Heijmen L, Janssen MJR. [18F]PSMA-1007 PET for biochemical recurrence of prostate cancer, a comparison with [18F]Fluciclovine. EJNMMI Rep. 2024 Nov 27;8(1):38. doi: 10.1186/s41824-024-00228-2.

Reference Type: DERIVED

PMID: 39592501 (View on PubMed)

Other Identifiers

NL65593.091.18

Identifier Type: -

Identifier Source: org_study_id