Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging.

NCT03465579 | Terminated

• 1 other identifier: IRST185.05
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 2

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-body 68Ga-PSMA PET/CT for diagnosis of clinically-significant prostate cancer and pre-surgical staging.

Conditions

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

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

Outcome Measures

Primary Outcomes (4)

• sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging

  sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging will be calculated as the ratio between the number of positive cases at 68Ga-PSMA PET/CT or mp-3TMRI and number of patients who underwent to these exams

  up to 36 months

• specificity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging

  specificity will be calculated considering negative cases at 68Ga-PSMA PET/CT or mp-3TMRI and number of patients who underwent to these exams

  up to 36 months

• Positive predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging

  Positive predictive value will be calculated considering the ratio between positive patient at 68Ga-PSMA PET/CT/mp-3TMRI confirmed as positive throughout biopsy and overall positive patient at 68Ga-PSMA PET/CT/mp-3TMRI

  up to 36 months

• negative predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging

  negative predictive value will be calculated considering the ratio between negative patient at 68Ga-PSMA PET/CT/mp-3TMRI confirmed as negative throughout biopsy and overall negative patient at 68Ga-PSMA PET/CT/mp-3TMRI

  up to 36 months

Secondary Outcomes (1)

• Incidence of adverse events

  up to 30 days following study procedures

Study Arms (4)

Cohort 1

OTHER

Men with suspected clinically-significant PCa (CS-PCa) who are candidates for prostate biopsy or after first-round negative transrectal ultrasonography (TRUS) biopsy

Diagnostic Test: pelvic MRI; Diagnostic Test: 68Ga-PSMA PET/CT

Cohort 2

OTHER

Men framed in Active Surveillance (PRIAS study), scheduled for PRIAS repeat biopsy.

Diagnostic Test: pelvic MRI; Diagnostic Test: 68Ga-PSMA PET/CT

Cohort 3a

OTHER

Men with high-risk PCa (HR-PCa) prior to radical surgery.

Diagnostic Test: pelvic MRI; Diagnostic Test: 68Ga-PSMA PET/CT

Cohort 3b

OTHER

Men diagnosed with CS-PCa prior to nerve-sparing prostate surgery (NSS).

Diagnostic Test: pelvic MRI; Diagnostic Test: 68Ga-PSMA PET/CT

Interventions

pelvic MRI DIAGNOSTIC_TEST

multi-parametric pelvic MRI

Cohort 1; Cohort 2; Cohort 3a; Cohort 3b

68Ga-PSMA PET/CT DIAGNOSTIC_TEST

68Ga-PSMA PET/CT

Cohort 1; Cohort 2; Cohort 3a; Cohort 3b

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort 1 - Biopsy guidance in clinically-suspected PCa
• \. 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
• 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:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (2)

AUSL della Romagna

Forlì, FC, 47121, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, 47014, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Federica Matteucci

  IRST IRCCS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: May 23, 2018
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

IT (2)