mp-3tmri and 68ga-psma pet/ct guided prostate biopsy and tumor node metastasis (tnm) staging.

Conditions: 68Ga-PSMA PET/CT Guided Prostate Biopsy; Mp-3TMRI Guided Prostate Biopsy; Prostate Cancer; TNM Staging; Diagnosis

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-body 68ga-psma pet/ct for diagnosis of clinically-significant prostate cancer and pre-surgical staging.

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 enhancement (dce) and 68ga-chelated prostate specific membrane antigen ligand (68ga-psma) positron emission tomography/computed tomography (pet /ct) in three cohorts of patients: * cohort 1 guiding prostate biopsies in men with clinical suspicion and/or unconfirmed clinically-significant prostate cancer (cs-pca) on initial prostate biopsy; * cohort 2 targeting repeat prostate biopsy in patients on active surveillance (prias study), scheduled for prias repeat biopsy; * cohort 3 providing pelvic / whole-body pre-surgical staging in: * 3a: men with high-risk pca (hr-pca); * 3b: men candidates for nerve sparing surgery (nss);

Eligibility criteria:
inclusion criteria: 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) \ 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: 1. histologically-proven adenocarcinoma of the prostate; 2. age ≥ 18 3. men should be fit for curative treatment; 4. clinical stage t1c or t2; 5. gleason score 3+3=6; 6. one or two biopsy cores invaded with prostate cancer: 1. 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); 2. 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); 7. psa density (psa d) less than 0.2; 8. psa-level at diagnosis ≤ 10 ng/ml; cohort 3a - pre-surgical tnm staging in high-risk prostate cancer 1. male, aged 18 years or older; 2. cyto / histological confirmation of pca (i.e. trus-guided biopsies; turp); 3. any of the pca high risk features for organ-confined disease (ocd): * clinical t stage ≥ t2c; * gleason score ≥ 8; * serum psa \> 20 ng/ml; 4. 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; 5. 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 1. male, aged 18 years or older; 2. cyto / histological confirmation of pca (i.e. trus-guided biopsies; turp); 3. 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 criteria: the participant may not enter the study if any of the following apply: 1. hormone androgen deprivation therapy of any type within 6 months prior to enrollment. 2. prior pelvic radiotherapy; 3. sickle cell disease; 4. insufficient renal function (egfr \< 30 ml/min/1.73 m2); 5. hip prosthesis, vascular grafting or other conditions affecting imaging; 6. 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); 7. 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.

Keywords: diagnosis prostate cancer tnm staging 68ga-psma pet/ct guided prostate biopsy mp-3tmri guided prostate biopsy pre-surgical staging clinically-suspected prostate cancer