Clinical trial NCT06402552: Comparing Bp-MRI and Mp-MRI for Prostate Cancer Screening Accuracy
Official title: A Randomized Controlled Trial Comparing Bp-MRI and Mp-MRI on the Screening Accuracy for Clinically Significant Prostate Cancer Before MRI-fusion Targeted Biopsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Randomized Controlled Trial
Prostate Cancer
Magnetic Resonance Imaging
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 370
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 3.1 Study Objectives: 3.1.1 Primary objective: The investigators aim to address these questions for Taiwan males suspicious of csPCA, with PSA range of 4-20 ng/ml by conducting a RCT trial.

3.2 Study endpoints: 3.2.1 Primary endpoint: The proportion of men with clinically significant Prostate cancer(csPCa), defined as a diagnosis of ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer, in at least one biopsy core.

3.2.2 Secondary endpoints:

1. The proportion of men with a diagnosis of any PCa
2. The proportion of men with a diagnosis of clinically insignificant PCa, defined as ISUP grade group 1 PCa (ISUP 1 PCa)
3. The proportion of men with a diagnosis of csPCa
4. Only in targeted biopsy
5. Only in systematic biopsy
6. The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI.

Detailed description: Study intervention MRI prostate Bi-parametric and multi-parametric MRI prostates can be performed using a 3.0 Tesla scanner with a pelvic phased array coil with or without contrast. MRI findings will be reported according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations. MRI will be reported by radiologists with experience in MRI prostate reporting. PI-RADS scores 3-5 will be regarded as suspicious, and targeted plus systematic biopsy will be performed.

Prostate biopsy In patients with suspicious lesion found on MRI (identified as PI-RADS score 3-5 lesions on bp-MRI or mp-MRI), biopsies will be done via trans-perineal approach under general anesthesia with 3 cores of targeted biopsy from each lesion, alone with 3 cores of systemic biopsy from right and left lobes respectively.

In those without identified suspicious lesions on MRI, a standard 12-core systematic biopsy will be performed via trans-rectal approach under local anesthesia.

All biopsies will be performed by Urologists experienced in both targeted and systemic prostate biopsy. Targeted biopsies will be done by software-assisted MRI-USG fusion registration. Peri-biopsy antibiotics are given according to our clinical guidelines.

Post-biopsy management Patients will be discharged after prostate biopsy when they can pass urine without significant gross hematuria, and clinically stable. They will be followed up in the clinic within 10 days after a biopsy to review pathology results and complications. All biopsies will be assessed by experienced Urogenital pathologists and reported according to the International Society of Urological Pathology (ISUP) consensus. The study period ends after the first clinic follow-up.

In our medical research, the investigators prioritize protecting participant privacy and confidentiality. The investigators use unique research codes to anonymize personal details like names and IDs. The principal investigator keeps consultation results and diagnoses confidential, even in published research. Participants consent to have their records reviewed by authorized parties for legal and ethical compliance, with a promise of maintaining their anonymity. For safety, the investigators may inform participants' other doctors about their trial involvement to manage treatment interactions. Overall, these steps ensure participant privacy and safety throughout the research.

Eligibility criteria: Inclusion Criteria:

1. Men ≥50 years of age
2. Clinical suspicion of prostate cancer and indicated for prostate biopsy
3. Serum Prostate-specific antigen (PSA) between 4\~20 ng/mL
4. Eligible for MRI study
5. Digital rectal examination ≤ cT2 (organ-confined cancer)
6. Able to provide written informed consent.

Exclusion Criteria:

1. Prior prostate biopsy in the 6 months before screening visit
2. Prior diagnosis of prostate cancer
3. Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
4. Contraindicated to MRI study: contrast medium allergy, claustrophobia, or other contraindications (e.g.: intra-abdominal metal foreign bodies).
5. Patients without histological results of prostate biopsies due to patient refusal for biopsy or loss of follow up before biopsy being done
6. Patients have prior treatments for prostate cancers or any kinds of hormone therapy, immunotherapy, chemotherapy, radiation therapy of the pelvic cavity.
7. Patients' withdrawal of informed consents of this study

Withdrawal criteria:

1. Patients could not complete the scheduled MRI examinations
2. MRI images of insufficient quality to localized csPCA or to exclude the presence of csPCA

Primary outcomes:
measure: Prevalence of Clinically Significant Prostate Cancer among Men as Defined by ISUP Grade Group ≥2 in Biopsy Samples
timeFrame: 2-3 weeks
Secondary outcomes:
measure: Prostate Cancer Diagnosis Rates and Specifics in Biopsy Methods
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Taoyuan city
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
References: