Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-85
SponsorPeking University First Hospital
About this trial
The goal of this randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes in prostate cancer diagnosis among men with multiple MRI visible lesions, including combination of targeted and perilesional (PB) (TPLBx) and combination of systematic biopsy and targeted biopsy (CTSBx).
The main questions it aims to answer are:
Does TPLBx promote the accurate diagnosis of clinically significant prostate cancer (csPCa) among men with multiple MRI visible lesions? What's the value of TPLBx in improving the evaluation of prostate cancer when developing the treatment plan for patients with multiple MRI visible lesions? What's the value of TPLBx in avoiding the adverse pathological outcomes after the radical prostatectomy such as upgrade, upstage, and capsule invasion among patients with multiple MRI visible lesions? Researchers will compare the cancer detection rates of TPLBx and CTSBx to explore the efficacy of different prostate biopsy schemes.
Participants will:
Receive TPLBx or CTSBx.
Eligibility criteria
Qualifiers
the age of the patient is between 18 and 85;
no previous biopsy;
presence of multiple MRI visible lesions;
every MRI visible lesion is in accordance with the EAU guidelines for performing perilesional biopsy (PB) (PI-RADS ≥4 or PI-RADS =3, clinical suspicion of PCa);
Disqualifiers
contraindication for MRI examination (i.e., in acute attack period such as high fever, coma, epilepsy, prone to cardiac arrest, claustrophobia, presence of ferrous metallic implants, or claustrophobia);
contraindication for prostate biopsy ((a) in the period of acute infection or fever; (b) hypertensive crisis; (c) in the decompensated stage of heart failure; (d) diseases with severe bleeding tendency; (e) poorly controlled complications of hypertension or diabetes; (f) patients with severe internal or external hemorrhoids, perianal or rectal lesions should not undergo transrectal biopsy);
a history of radiotherapy, chemotherapy, androgen deprivation therapy, or surgery for PCa;
patients with previous biopsy;
Trial design
Treatments tested in this trial
- Targeted and perilesional biopsy (TPLBx)
- Combined targeted and systematic biopsy (CTSBx)
Treatment groups
572 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov