68Ga-PSMA PET/CT Guided Prostate BiopsyBIOPSTAGENCT03465579
Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging.
A study testing pelvic MRI and 68Ga-PSMA PET/CT in people with 68Ga-PSMA PET/CT Guided Prostate Biopsy and Mp-3TMRI Guided Prostate Biopsy, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- 68Ga-PSMA PET/CT Guided Prostate Biopsy, Mp-3TMRI Guided Prostate Biopsy, Prostate Cancer
- What is being tested?
- pelvic MRI and 68Ga-PSMA PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 2 sitesItaly
- Study dates
- 23 May 2018to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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:
- 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
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- 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;
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
AUSL della Romagna
Forlì, FC, 47121
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, 47014
About this study
Official title: 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.
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.
Read the 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);
- Conditions
- 68Ga-PSMA PET/CT Guided Prostate Biopsy, Mp-3TMRI Guided Prostate Biopsy, Prostate Cancer, TNM Staging, Diagnosis
- Being tested
- pelvic MRI, 68Ga-PSMA PET/CT
- 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
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic MRIDiagnostic test
multi-parametric pelvic MRI
68Ga-PSMA PET/CTDiagnostic test
68Ga-PSMA PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: pelvic MRI; Diagnostic Test: 68Ga-PSMA PET/CT |
| Cohort 3a | Other | Men with high-risk PCa (HR-PCa) prior to radical surgery. Receives: 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). Receives: Diagnostic Test: pelvic MRI; Diagnostic Test: 68Ga-PSMA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 36 months
Secondary outcomes (1)
Incidence of adverse events
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.
Measured: up to 30 days following study procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start23 May 2018
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 68Ga-PSMA PET/CT Guided Prostate BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federica Matteucci, Study chair, IRST IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465579
- Sponsor's protocol ID
- IRST185.05
- Acronym
- BIOPSTAGE
- Status last verified
- Jan 2025
- First submitted
- 8 Mar 2018
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03465579
- Acronym / sponsor ID
- BIOPSTAGE / IRST185.05
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 23 May 2018 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Diagnostic Test: pelvic MRI, Diagnostic Test: 68Ga-PSMA PET/CTMen with suspected clinically-significant PCa (CS-PCa) who are candidates for prostate biopsy or after first-round negative transrectal ultrasonography (TRUS) biopsy |
| Cohort 2 | Other | Diagnostic Test: pelvic MRI, Diagnostic Test: 68Ga-PSMA PET/CTMen framed in Active Surveillance (PRIAS study), scheduled for PRIAS repeat biopsy. |
| Cohort 3a | Other | Diagnostic Test: pelvic MRI, Diagnostic Test: 68Ga-PSMA PET/CTMen with high-risk PCa (HR-PCa) prior to radical surgery. |
| Cohort 3b | Other | Diagnostic Test: pelvic MRI, Diagnostic Test: 68Ga-PSMA PET/CTMen diagnosed with CS-PCa prior to nerve-sparing prostate surgery (NSS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- 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:
- 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:
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic MRImulti-parametric pelvic MRI | Diagnostic test | Cohort 1, Cohort 2, Cohort 3a, Cohort 3b |
| 68Ga-PSMA PET/CT68Ga-PSMA PET/CT | Diagnostic test | Cohort 1, Cohort 2, Cohort 3a, Cohort 3b |
Primary outcome
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
1 secondary outcome
Incidence of adverse events
Time frame: up to 30 days following study procedures
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federica Matteucci study chair
IRST IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic MRI and 68Ga-PSMA PET/CT in people with 68Ga-PSMA PET/CT Guided Prostate Biopsy and Mp-3TMRI Guided Prostate Biopsy, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging (time frame: up to 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.