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

NCT03187990 | Completed DMC

• 1 other identifier: KEK-ZH-NR: 2017-00016
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

PSMA PET/MRI; Guided Biopsy; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of positive histopathology for [68Ga]PSMA-11 positive lesions

  PCA detection of PET/MRI versus mpMRI based on histopathology per patient and per prostate section.

  7 months

Secondary Outcomes (1)

• Correlation of [68Ga]PSMA-11 with tumor aggressiveness

  7 months

Study Arms (2)

PET/MRI before biopsy

EXPERIMENTAL

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

Drug: [68Ga]PSMA-11; Drug: [18F]PSMA-1007

PET/MRI after biopsy

EXPERIMENTAL

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.

Drug: [68Ga]PSMA-11

Interventions

[68Ga]PSMA-11 DRUG

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

Also known as: PSMA PET/MRI

PET/MRI after biopsy; PET/MRI before biopsy

[18F]PSMA-1007 DRUG

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

Also known as: PSMA PET/CT

PET/MRI before biopsy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients can have negative prior needle biopsy(ies) for suspected prostate cancer
• mpMRI with at least one suspicious target lesion (Arm A), or negative mpMRI but positive biopsy (Arm B).
• Written informed consent
• Age \> 30

You may not qualify if:

• Age\> 80
• 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)
• Active urinary tract infection or indwelling catheter
• Prior pelvic irradiation
• Prior prostatectomy
• Prior androgen deprivation hormonal therapy
• Prostate biopsy within 8 weeks prior to study
• Prior transurethral resection of the prostate (TURP)

Sponsors & Collaborators

• Irene Burger: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 34725726 DERIVED

• 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.

  PMID: 33620559 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Irene A Burger, MD

  UniversitaetsSpital Zuerich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: In both arms PET/MR is compared to mpMRI for diagnostic accuracy for PCA detection.

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: March 3, 2017
• Primary Completion: August 3, 2021
• Study Completion: August 3, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)