The primary objective of this study is to evaluate the added value of PSMA PET/CT and PSMA-targeted biopsies of PSMA-avid lesions in detecting ISUP GG ≥ 2 prostate cancer in patients with a negative or equivocal MRI (PIRADS 1-3) and a PSA density of…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
- Intervention with ionizing radiation
N.a.
Outcome measures
Primary outcome
<p>Detection rates of ISUP GG≥2 PCa in target biopsies of PSMA PET/CT lesions, which were not detected, by systematic biopsies.</p>
Secondary outcome
<p>- Detection rates of ISUP GG≥2 PCa in systematic biopsies in case of negative or equivocal MRI and PSMA PET/CT.<br>- Detection rates of ISUP GG≥2 PCa in systematic biopsies and negative or ISUP GG 1 result of PSMA lesion target biopsies.<br>- Level of SUVmax in correlation with with ISUP GG ≥2 PCa.<br>- Detection of clinically insignificant PCa (ISUP GG 1) in both PSMA-guided target biopsies and in systematic biopsies<br>- Percentage of change in management in case of upgrading based on PSMA-guided biopsies.<br>- Cost-effectiveness of an extra PSMA PET/CT scan.</p>
Background summary
In the current biopsy strategy based on MRI imaging of the prostate, approximately 10% of significant prostate cancers (sPCa) are missed. The addition of a PSMA PET/CT scan in a select group of patients may potentially detect these missed sPCa cases. Data from the PASPoRT study, conducted at our institution, supports the hypothesis that PSMA PET/CT can provide added diagnostic value. This study focused on patients with low-risk prostate cancer. Following the addition of PSMA PET/CT and targeted biopsies of suspicious PSMA lesions, 9% of patients experienced upstaging. In a subgroup with a PSA density (PSA divided by prostate volume) ≥ 0.15, the rate of upstaging was as high as 35%.
In the present study, we aim to evaluate the detection of sPCa using an additional PSMA PET/CT scan in men with a negative or equivocal MRI (PIRADS 1-3) scan but a high suspicion of sPCa due to elevated PSA density.
Study objective
The primary objective of this study is to evaluate the added value of PSMA PET/CT and PSMA-targeted biopsies of PSMA-avid lesions in detecting ISUP GG ≥ 2 prostate cancer in patients with a negative or equivocal MRI (PIRADS 1-3) and a PSA density of ≥0.20 ng/ml/cm³.
Additionally, we aim to assess the number of ISUP GG ≥ 2 cases detected through systematic biopsies that are not identified by PSMA-targeted biopsies or in the absence of a PSMA-avid lesion. This evaluation seeks to determine whether systematic biopsies are necessary when no PSMA-avid lesion is present for targeted biopsy.
Study design
Prospective observational cohort study
Intervention
Patients with a high suspicion of prostate cancer (PCa) based on elevated PSA levels and/or abnormal digital rectal examination(DRE), and a prostate-specific antigen density (PSAD) ≥ 0.20 ng/ml/cm³, but with a negative or equivocal prostate MRI result(PIRADS 1-3) will undergo an extra PSMA PET/CT.
Study burden and risks
Participation in the study may allow for earlier detection of more aggressive histology. In addition to standard care (including: MRIscan, systematic transperineal biopsies, targeted biopsies of MRI lesions), a PSMA-PET/CT scan will be performed. The PSMA-PETscan will require an extra visit, iv drip and small radiation burden. If there is a visible lesion on PSMA PET/CT, an extra target biopsy will be performed with a potential higher risk of complication: hematospermia, hematuria, infection, fever, pain). The risk of fever and infection is nihil, due to the transperineal biopsy technique that will be used.
V Sweere
Koekoekslaan 1
Nieuwegein 3435 CM
Netherlands
0612138028
v.sweere@antoniusziekenhuis.nl
V Sweere
Koekoekslaan 1
Nieuwegein 3435 CM
Netherlands
0612138028
v.sweere@antoniusziekenhuis.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- Men aged > 18 years old
- PSA 3-20 ng/ml
- Negative or equivocal MRI (PIRADS 1-3)
- PSAD ≥0.20 ng/ml/cm3, which should be measured with at least two PSA results (for example one of the generalpractitioner and one of the urologist)
- Mentally competent and understanding of benefits and potential burden of the study.
- Written and signed informed consent.
- Willing to undergo study protocol (systemic biopsies plus target biopsies of a lesion visible on PSMA PET/CT)
Exclusion criteria
- PSA > 20 ng/ml
- Men who have previously undergone a prostate biopsy
- Men who have a prior PCa diagnosis
- Using any (anti-)hormonal therapy
- Not fulfilling inclusion criteria
- Inability to undergo MRI (i.e., claustrophobia, metal implants)
- Inability to undergo PSMA PET/CT (i.e., allergic reaction to 68Ga-PSMA or other contrast fluids, claustrophobia)
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Research portal | NL-009325 |