Evaluation of [68Ga]PSMA PET/MRI in intermediate and high risk prostate cancer – a comparison with mpMRI, [11C]ACE PET/CT and histopathological validation

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005046-55-SE

Enrollment

Unknown

Registered

2016-06-09

Start date

2016-08-23

Completion date

Unknown

Last updated

2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medium and high risk prostate cancer

Interventions

Product Name: [68Ga]Ga-HBED-CC-PSMA-11 Product Code: [68Ga]PSMA Pharmaceutical Form: Solution for injection INN or Proposed INN: [68Ga]-HBED-CC PSMA-11 Current Sponsor code: [68Ga]PSMA Other descripti

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Histologically confirmed intermediate/high risk prostate cancer - =2 months since last biopsy of the prostate - Gleason 3+4 or higher - Written informed consent - > 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - Non MR-safe implants or other contraindication to MRI,PET or CT - WHO PS>1 - TUR-P within 6 months - Metastatic disease in skeleton, parenchymal organs or lymph nodes outside the pelvis - Creatinine clearance < 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)

Design outcomes

Primary

Measure	Time frame
Main Objective: Our hypothesis is that [68Ga]PSMA PET/MRI imaging will provide a sensitive diagnostic tool of primary, secondary (metastasis) and recurrent PC tumours as well as allowing for accurate staging of PC prior to treatment. The goal is to determine if [68Ga]PSMA is safe and not associated with any side-effects and other adverse events. The goal is also to test the hypothesis that [68Ga]PSMA PET/MRI provides improved staging and grading of prostate cancer compared to [11C]ACE PET/CT and standalone mpMRI. ;Secondary Objective: Not applicable;Primary end point(s): • To evaluate the safety and performance of [68Ga]PSMA PET/MRI when used in diagnosis and treatment planning applications of prostate cancer. • If [68Ga]PSMA PET/MRI will correctly detect/define 80% of index tumor lesions, with a diameter of at least 7 (5) mm. ;Timepoint(s) of evaluation of this end point: Not more than 2 years after LVLS	—

Measure

Time frame

Main Objective: Our hypothesis is that [68Ga]PSMA PET/MRI imaging will provide a sensitive diagnostic tool of primary, secondary (metastasis) and recurrent PC tumours as well as allowing for accurate staging of PC prior to treatment. The goal is to determine if [68Ga]PSMA is safe and not associated with any side-effects and other adverse events. The goal is also to test the hypothesis that [68Ga]PSMA PET/MRI provides improved staging and grading of prostate cancer compared to [11C]ACE PET/CT and standalone mpMRI. ;Secondary Objective: Not applicable;Primary end point(s): • To evaluate the safety and performance of [68Ga]PSMA PET/MRI when used in diagnosis and treatment planning applications of prostate cancer. • If [68Ga]PSMA PET/MRI will correctly detect/define 80% of index tumor lesions, with a diameter of at least 7 (5) mm. ;Timepoint(s) of evaluation of this end point: Not more than 2 years after LVLS

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Sweden

Contacts

Public ContactKatrine Åhlström Riklund

Umeå University Hospital

46907850000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026