NCT04239742

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 13, 2020

Last Update Submit

January 23, 2020

Conditions

Prostate Cancer Recurrent

Keywords

18F-PSMA-100718F-Fluciclovine

Outcome Measures

Primary Outcomes (2)

  • Detection efficacy of the two PET-tracers on a per patient level

    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

    Comparisson of number of positive lesions

    Follow-up duration is 6 months.

Secondary Outcomes (7)

  • Quantitative analysis

    6 months

  • Comparing specificity

    6 months

  • Sensitivity per area, local recurrence

    6 months

  • Sensitivity per area, locoregional lymph nodes

    6 months

  • Sensitivity per area, distant lymph nodes

    6 months

  • +2 more secondary outcomes

Study Arms (1)

18F-PSMA PET/CT and 18F-Fluciclovin PET/CT

EXPERIMENTAL

patients undergo an 18F-PSMA PET/CT scan and an 18F-Fluciclovin PET/CT scan, within a time frame of two weeks.

Diagnostic Test: F18-fluciclovine PET/CTDiagnostic Test: F18-PSMA-1007 PET/CT

Interventions

F18-fluciclovine PET/CTDIAGNOSTIC_TEST

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

Also known as: Axumin scan
18F-PSMA PET/CT and 18F-Fluciclovin PET/CT
F18-PSMA-1007 PET/CTDIAGNOSTIC_TEST

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

Also known as: PSMA scan
18F-PSMA PET/CT and 18F-Fluciclovin PET/CT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39592501DERIVED

Study Officials

  • James Nagarajah, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Willemijn van Gemert, MD, PhD

CONTACT

0031243614510willemijn.vangemert@radboudumc.nl

James Nagarajah, MD, PhD

CONTACT

0031243614510James.nagarajah@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
scans will be anonymized for study outcome assessment.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: every individual gets two diagnostic PET CT scans within 2 weeks apart.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 27, 2020

Study Start

January 2, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)