Status:
TERMINATED
Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging.
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
68Ga-PSMA PET/CT Guided Prostate Biopsy
Mp-3TMRI Guided Prostate Biopsy
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
BIOPSTAGE is a prospective, non-randomized, diagnostic, multi-cohort investigational study to evaluate the impact of pelvic Multi-parametric 3-Tesla magnetic resonance imaging (mp-3TMRI) and whole-bod...
Detailed Description
The aim of this study is to characterize the diagnostic accuracy of both multi-parametric pelvic Magnetic Resonance Imaging (MRI) (T2-weighted, Diffusion Weighted Imaging (DWI), Dynamic Contrast Enhan...
Eligibility Criteria
Inclusion
- Cohort 1 - Biopsy guidance in clinically-suspected PCa
- 1\. Men aged 45 to 75 years old with clinically-suspected PCa candidated for either initial or repeat TRUS-guided prostate biopsy, meeting any of the following criteria:
- a) Abnormal PSA metrics, defined as follows:
- A rising and/or persistently elevated serum PSA (i.e PSA \> 2.5ng/ml for men in the age group comprising 60 to 75 years old; PSA \> 3.0ng/ml for men in the age group comprising 45 to 60 years old) and at least one of the following PSA-based metrics:
- i. Percent free PSA (%fPSA) \< 25% with PSA range 4-10ng/ml (NCCN); ii. PSA velocity (PSAvel) \>0.35 ng/mL/y; iii. PSA density (PSAden) \> 0.25ng/mL/cc iv. PSA \> 10ng/ml, 50% risk of PCa (EAU) b) Suspicious digital rectal examination (DRE), 5-30% risk of PCa; c) Prostate Cancer Gene 3 (PCA3) \> 35; d) Suspicious findings on first-round biopsy: i. A few Atypical Glands immediately adjacent to HG-PIN, 50% risk of PCa; ii. Atypical Small Acinar Proliferation, 40% of PCa; iii. Multifocal High-Grade Prostatic intraepithelial neoplasia (HG-PIN), 30% ; iv. Intraductal carcinoma as solitary finding, 90% of PCa;
- Cohort 2 - Biopsy guidance on Active Surveillance
- Men consenting to enter the PRIAS MRI side-study as per currently inclusion criteria in Version Number 1.0 dated August 20, 2013. These are:
- Histologically-proven adenocarcinoma of the prostate;
- Age ≥ 18
- Men should be fit for curative treatment;
- Clinical stage T1c or T2;
- Gleason score 3+3=6;
- One or two biopsy cores invaded with prostate cancer:
- If an MRI, including targeted biopsies on positive lesions, is done at inclusion, there is no limit in the number of positive cores (that is, more than two, and no limit in the % of cancer present in the cores);
- If saturation biopsies (either trans-perineal or trans-rectal) are done 15% of the cores can be positive with a maximum of 4 (i.e. 26 cores 4 cores can be positive) (all other inclusion criteria still apply);
- PSA density (PSA D) less than 0.2;
- PSA-level at diagnosis ≤ 10 ng/mL;
- Cohort 3a - Pre-surgical TNM staging in high-risk prostate cancer
- Male, aged 18 years or older;
- Cyto / histological confirmation of PCa (i.e. TRUS-guided biopsies; TURP);
- Any of the PCa high risk features for Organ-Confined Disease (OCD):
- Clinical T stage ≥ T2c;
- Gleason Score ≥ 8;
- Serum PSA \> 20 ng/mL;
- Any of the PCa high-risk features for Locally-Advanced Disease (LAD):
- Clinical T stage ≥ T3b-T4 OR any T and clinical N1 disease;
- Gleason Score ≥ 8;
- Serum PSA \> 20 ng/mL;
- Routine clinical staging (CTscan ± Bone scan) performed within 12 weeks enrolment returning negative or equivocal results for distant metastatic disease;
- Cohort 3b - pelvic TNM staging of prostate cancer prior to nerve-sparing radical prostatectomy
- Male, aged 18 years or older;
- Cyto / histological confirmation of PCa (i.e. TRUS-guided biopsies; TURP);
- All of the following PCa-related features must be met for nerve-sparing (either mono- or bi-lateral):
- Clinical T stage ≤ T2b;
- Gleason Score ≤ 7 (3+4) and maximum one biopsy with Gleason \> 6 at the ipsilateral side;
- Serum PSA \< 10 ng/mL;
Exclusion
- The participant may not enter the study if ANY of the following apply:
- Hormone androgen deprivation therapy of any type within 6 months prior to enrollment.
- Prior pelvic radiotherapy;
- Sickle cell disease;
- Insufficient renal function (eGFR \< 30 mL/min/1.73 m2);
- Hip prosthesis, vascular grafting or other conditions affecting imaging;
- Contraindication to MRI, including but not restricted to: pacemaker or other electronic im-plants, known metal in the orbit, MR incompatible surgical or cerebral aneurysm clips, shrapnel, tattoos, non-removable body piercings (relative contraindications);
- History of allergic reactions attributed to compounds of similar chemical or biologic com-position to 68Ga-PSMA or Gadolinium-based contrast agents used in the study.
Key Trial Info
Start Date :
May 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT03465579
Start Date
May 23 2018
End Date
September 3 2024
Last Update
January 30 2025
Active Locations (2)
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1
AUSL della Romagna
Forlì, FC, Italy, 47121
2
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy, 47014