NCT03307460

Brief Summary

Prospective study to evaluate the value of uPAR-targeted PET/MR scan using the tracer 68Ga-NOTA-AE105 in patients with newly diagnosed prostate cancer

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
52

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Nov 2017

Typical duration for phase_2 prostate-cancer

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

First Submitted

Initial submission to the registry

October 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

October 6, 2017

Last Update Submit

November 20, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Correlation with Gleason Score

    Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material.

    3 months after PET/MRI

Secondary Outcomes (2)

  • Prognostic value

    3 years from PET/MRI

  • Diagnostic accuracy in staging lymph nodes

    3 months from PET/MRI

Study Arms (1)

uPAR PET/MRI

EXPERIMENTAL

68Ga-NOTA-AE105 is injected once for performing a PET/MRI scan

Drug: 68Ga-NOTA-AE105

Interventions

68Ga-NOTA-AE105DRUG

PET/MRI scan

Also known as: PET/MRI
uPAR PET/MRI

Eligibility Criteria

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

You may qualify if:

  • Histologically verified prostate cancer
  • Capable of understanding written information and giving informed consent
  • Planned to enter active surveillance strategy or undergo therapy with curative intent (surgery or radiotherapy)

You may not qualify if:

  • Obesity (Body weight over 140 kg)
  • Known allergy to 68-Ga-NOTA-AE105
  • Metallic components in the body that contradicts MRI scan
  • Severe claustrophobia making the person unable to complete an MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Marie Ø Fosboel, MD

    Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 11, 2017

Study Start

November 21, 2017

Primary Completion

October 11, 2019

Study Completion

April 1, 2022

Last Updated

November 23, 2020

Record last verified: 2020-11

Locations

DK(1)