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

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ClinicalTrials.gov Identifier: NCT03465579
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Tracking Information
First Submitted Date  ICMJE March 8, 2018
First Posted Date  ICMJE March 14, 2018
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE May 23, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging [ Time Frame: up to 36 months ]
    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
  • specificity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging [ Time Frame: up to 36 months ]
    specificity will be calculated considering negative cases at 68Ga-PSMA PET/CT or mp-3TMRI and number of patients who underwent to these exams
  • Positive predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging [ Time Frame: up to 36 months ]
    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
  • negative predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging [ Time Frame: up to 36 months ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
Incidence of adverse events [ Time Frame: up to 30 days following study procedures ]
The number and percentage of treated patients undergoing grade 1 to 4 adverse events will be tabulated for each cohort and diagnostic procedure, using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 should be used to assess and grade AE severity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging.
Official Title  ICMJE Multi-cohort Investigational Study to Evaluate the Impact of Pelvic Mp-3TMRI and Whole-body 68Ga-PSMA PET/CT for Diagnosis of Clinically-significant Prostate Cancer and Pre-surgical Staging.
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.
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 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);
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 68Ga-PSMA PET/CT Guided Prostate Biopsy
  • Mp-3TMRI Guided Prostate Biopsy
  • Prostate Cancer
  • TNM Staging
  • Diagnosis
Intervention  ICMJE
  • Diagnostic Test: pelvic MRI
    multi-parametric pelvic MRI
  • Diagnostic Test: 68Ga-PSMA PET/CT
    68Ga-PSMA PET/CT
Study Arms  ICMJE
  • Cohort 1
    Men with suspected clinically-significant PCa (CS-PCa) who are candidates for prostate biopsy or after first-round negative transrectal ultrasonography (TRUS) biopsy
    Interventions:
    • Diagnostic Test: pelvic MRI
    • Diagnostic Test: 68Ga-PSMA PET/CT
  • Cohort 2
    Men framed in Active Surveillance (PRIAS study), scheduled for PRIAS repeat biopsy.
    Interventions:
    • Diagnostic Test: pelvic MRI
    • Diagnostic Test: 68Ga-PSMA PET/CT
  • Cohort 3a
    Men with high-risk PCa (HR-PCa) prior to radical surgery.
    Interventions:
    • Diagnostic Test: pelvic MRI
    • Diagnostic Test: 68Ga-PSMA PET/CT
  • Cohort 3b
    Men diagnosed with CS-PCa prior to nerve-sparing prostate surgery (NSS).
    Interventions:
    • Diagnostic Test: pelvic MRI
    • Diagnostic Test: 68Ga-PSMA PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2018)
306
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) < 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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Oriana Nanni +390543739266 oriana.nanni@irst.emr.it
Contact: Federica Matteucci, MD +390543739100 federica.matteucci@irst.emr.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03465579
Other Study ID Numbers  ICMJE IRST185.05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Sponsor  ICMJE Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Federica Matteucci IRST IRCCS
PRS Account Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP