Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA

NCT ID: NCT03187990

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-03
• Study Completion Date: 2021-08-03

Brief Summary

In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the ability of [68Ga]PSMA PET/MRI to detect and localize significant primary PCA to accurately direct prostate needle biopsy using the Gleason score from the histology of the core biopsies as standard of truth.

Detailed Description

In this open label, single center, non-randomized, diagnostic study we plan to include 40 men with elevated PSA (ages 30-50 PSA >2.5 ng/mL; ages 50-80 PSA > 4ng/mL), which are assigned to a MRI guided biopsy.

These patients will undergo one additional PET/MRI scan with [68Ga]PSMA within two to three weeks before the biopsy (Arm A), or in case of an unclear/negative MRI scan but positive biopsy two to three weeks after biopsy (Arm B). In Arm A a radiologist will delineate the suspected areas on (A) multiparametric magnetic resonance image (mpMRI) and a nuclear medicine physician will delineate and color code the suspicious areas on the PET/MRI: (B) [68Ga]PSMA. The images will be loaded into the BiopSee® system. Lesions positive on both modalities will be labeled as "AB". Every suspicious lesion will be targeted with 3 cores. A maximum of 3 targets will be selected per patient.

For arm B: PET/MRI results will be correlated with the template biopsy results.

The data analysis of Arm A and Arm B will be identical. For the analysis the Gleason score from the histology of the core biopsies will serve as standard of truth.

After completion of the PET/MR study part - an amendment for PET/CT was submitted to the local ethics commity and acknowledged to include 10 more participants with PSMA PET/CT to investigate the use of PET/CT guided biopsy and intraoperative verivication of the target with a gamma counter.

Conditions

Prostate Cancer

Study Design

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

Study Groups

PET/MRI before biopsy

Patients with suspected areas on mpMRI will undergo additional \[68Ga\]PSMA-11 PET/MRI scan with subsequent mpMRI and PET/MRI guided biopsy.

Group Type: EXPERIMENTAL

[68Ga]PSMA-11

Intervention Type: DRUG

PET/MRI with \[68Ga\]PSMA will be compared to mpMRI for biopsy guidance.

[18F]PSMA-1007

Intervention Type: DRUG

18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.

PET/MRI after biopsy

Patients with unclear areas or a negative finding in the mpMRI for MRI guided biopsy but positive biopsy, which will undergo the additional \[68Ga\]PSMA-11 PET/MRI scan with \[68Ga\]PSMA.

Group Type: EXPERIMENTAL

[68Ga]PSMA-11

Intervention Type: DRUG

PET/MRI with \[68Ga\]PSMA will be compared to mpMRI for biopsy guidance.

Interventions

[68Ga]PSMA-11

PET/MRI with \[68Ga\]PSMA will be compared to mpMRI for biopsy guidance.

Intervention Type: DRUG

[18F]PSMA-1007

18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.

Intervention Type: DRUG

Other Intervention Names

PSMA PET/MRI; PSMA PET/CT

Eligibility Criteria

Inclusion Criteria

1. Previously undiagnosed patients with elevated PSA (ages 30-50 PSA >2.5 ng/mL; ages 50-80 PSA > 4ng/mL), eligible for prostate needle biopsy.

2. Patients can have negative prior needle biopsy(ies) for suspected prostate cancer

3. mpMRI with at least one suspicious target lesion (Arm A), or negative mpMRI but positive biopsy (Arm B).

4. Written informed consent

5. Age > 30

Exclusion Criteria

1. Age> 80

2. Contraindication to MRI or prostate biopsy (e.g. extreme claustrophobia, metallic implants incompatible with MRI, anatomical contraindications, coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies)

3. Active urinary tract infection or indwelling catheter

4. Prior pelvic irradiation

5. Prior prostatectomy

6. Prior androgen deprivation hormonal therapy

7. Prostate biopsy within 8 weeks prior to study

8. Prior transurethral resection of the prostate (TURP)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Irene Burger

OTHER

Sponsor Role: lead

Responsible Party

Irene Burger

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Irene A Burger, MD

Role: PRINCIPAL_INVESTIGATOR

UniversitaetsSpital Zuerich

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

Ferraro DA, Laudicella R, Zeimpekis K, Mebert I, Muller J, Maurer A, Grunig H, Donati O, Sapienza MT, Rueschoff JH, Rupp N, Eberli D, Burger IA. Hot needles can confirm accurate lesion sampling intraoperatively using [18F]PSMA-1007 PET/CT-guided biopsy in patients with suspected prostate cancer. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1721-1730. doi: 10.1007/s00259-021-05599-3. Epub 2021 Nov 2.

Reference Type: DERIVED

PMID: 34725726 (View on PubMed)

Ferraro DA, Becker AS, Kranzbuhler B, Mebert I, Baltensperger A, Zeimpekis KG, Grunig H, Messerli M, Rupp NJ, Rueschoff JH, Mortezavi A, Donati OF, Sapienza MT, Eberli D, Burger IA. Diagnostic performance of 68Ga-PSMA-11 PET/MRI-guided biopsy in patients with suspected prostate cancer: a prospective single-center study. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3315-3324. doi: 10.1007/s00259-021-05261-y. Epub 2021 Feb 23.

Reference Type: DERIVED

PMID: 33620559 (View on PubMed)

Other Identifiers

KEK-ZH-NR: 2017-00016

Identifier Type: -

Identifier Source: org_study_id