Prostate Cancer
Conditions
Keywords
PSMA PET/MRI, Guided Biopsy, Prostate Cancer
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.
Interventions
DRUG[68Ga]PSMA-11
PET/MRI with \[68Ga\]PSMA will be compared to mpMRI for biopsy guidance.
DRUG[18F]PSMA-1007
18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.
Sponsors
Irene Burger
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
In both arms PET/MR is compared to mpMRI for diagnostic accuracy for PCA detection.
Eligibility
Sex/Gender
MALE
Age
30 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of positive histopathology for [68Ga]PSMA-11 positive lesions | 7 months | PCA detection of PET/MRI versus mpMRI based on histopathology per patient and per prostate section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of [68Ga]PSMA-11 with tumor aggressiveness | 7 months | Correlation of stanadized uptake value (SUV) on \[68Ga\]PSMA-11 with Gleason Score on histopathology. |
Countries
Switzerland
Outcome results
None listed