Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging. (NCT03465579) | Clinical Trial Compass
TerminatedNot Applicable
Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging.
Stopped: Patients in cohort 1 continued for prolonged periods given the difficulties encountered in the COVID period and to date in this setting evidence has already developed that reduces the the innovativeness of the project.
Italy261 participantsStarted 2018-05-23
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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);
Exclusion criteria
✕. Hormone androgen deprivation therapy of any type within 6 months prior to enrollment.
✕
What they're measuring
1
sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Timeframe: up to 36 months
2
specificity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Timeframe: up to 36 months
3
Positive predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Timeframe: up to 36 months
4
negative predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Timeframe: up to 36 months
Trial details
NCT IDNCT03465579
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
✕. 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.