Multiparametric MRIPANDORANCT06867588
The Added-value of PSMA PET in Detecting Clinically Significant Prostate Cancer Lesions in Patients Undergoing MRI-targeted Biopsy. (PANDORA)
A study testing PSMA PET in people with Multiparametric MRI and Lesion PI-RADS 3, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT), an imaging modality focusing on a protein overexpressed by prostate cancer cells, has revolutionised the staging of both newly diagnosed and biochemically recurrent prostate cancer with better performance when compared… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Multiparametric MRI, Lesion PI-RADS 3
- What is being tested?
- PSMA PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subjects must meet the following criteria for inclusion in the study:
- Men ≥ 18 years of age
- Multiparametric MRI within the previous 6 months
- At least one lesion PI-RADS 3
- Able to provide written informed consent
Who cannot join
- Eligible subjects must not meet any of the exclusion criteria listed below:
- Previous prostate cancer diagnostic on MRI-targeted biopsy
- At least one lesion PI-RADS 4-5
- Negative MRI (PI-RADS 1-2)
- Previous treatment for prostate cancer 11
- Contraindication to PSMA PET and/or MRI and/or prostate biopsy
- Low quality of MRI defined by a PI-QUAL score of 1 or 2
- Any medical condition that may interfere with the study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1070
Loubna TARAJI
About this study
Official title: The Added-value of PSMA PET in Detecting Clinically Significant Prostate Cancer Lesions in Patients Undergoing MRI-targeted Biopsy. (PANDORA): a Prospective, Paired Diagnostic Study
Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT), an imaging modality focusing on a protein overexpressed by prostate cancer cells, has revolutionised the staging of both newly diagnosed and biochemically recurrent prostate cancer with better performance when compared to conventional imaging. Indeed, several studies have shown that PSMA PET/CT outperformed choline PET/CT with better detection rate of metastatic disease, particularly in the setting of disease recurrence after therapy even at (very) low PSA level. Moreover, the proPSMA trial reported that PSMA PET/CT had 27% greater accuracy than that of CT and bone scanning when staging patients with high-risk localised prostate cancer. More recently, availability of integrated PET/MRI scanners offers the opportunity for higher accuracy imaging and promising diagnostic studies. It also offers enhanced spatial integration that resulting in better contouring and targeting of prostate lesions.
In the light of current issues, the next question is whether PSMA PET imaging could add to the detection of prostate cancer. Several retrospective case-report studies reported promising results regarding the improved diagnostic accuracy of prostatic PSMA PET/CT . Recently, in the PRIMARY trial, 291 men received successively MRI, PSMA PET/CT and systematic ± MRI-targeted biopsies. Despite similar PPV between imaging methods, the main advantage of PSMA was in men with equivocal MRI. Indeed, they found that 90% of csPCa was identified by PSMA PET/CT in this subgroup and paved the way for further investigation. This finding was confirmed in the most recent systematic review and meta-analysis.
The aim of this prospective study is to evaluate the added-value of PSMA PET in detecting prostate cancer in patients who are candidates for biopsy with equivocal MRI.
- Conditions
- Multiparametric MRI, Lesion PI-RADS 3
- Being tested
- PSMA PET
- Keywords
- PSMA PET, MRI-targeted biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PETDiagnostic test
patients included in the study will perfom a PSMA PET
| Study group | Role | What they receive |
|---|---|---|
| Patients with at least one lesion PI-RADS 3 | Other | Not described Receives: Diagnostic Test: PSMA PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinically significant prostate cancer detected by PSMA PET-targeted biopsy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start17 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiparametric MRIStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867588
- Sponsor's protocol ID
- IJBPANDORA
- Acronym
- PANDORA
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 31 Mar 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 31 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added-value of PSMA PET in Detecting Clinically Significant Prostate Cancer Lesions in Patients Undergoing MRI-targeted Biopsy. (PANDORA): a Prospective, Paired Diagnostic Study
- ClinicalTrials.gov ID
- NCT06867588
- Acronym / sponsor ID
- PANDORA / IJBPANDORA
- Conditions
- Multiparametric MRI, Lesion PI-RADS 3
- Keywords
- PSMA PET, MRI-targeted biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Mar 2025 (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.
Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT), an imaging modality focusing on a protein overexpressed by prostate cancer cells, has revolutionised the staging of both newly diagnosed and biochemically recurrent prostate cancer with better performance when compared to conventional imaging. Indeed, several studies have shown that PSMA PET/CT outperformed choline PET/CT with better detection rate of metastatic disease, particularly in the setting of disease recurrence after therapy even at (very) low PSA level. Moreover, the proPSMA trial reported that PSMA PET/CT had 27% greater accuracy than that of CT and bone scanning when staging patients with high-risk localised prostate cancer. More recently, availability of integrated PET/MRI scanners offers the opportunity for higher accuracy imaging and promising diagnostic studies. It also offers enhanced spatial integration that resulting in better contouring and targeting of prostate lesions.
In the light of current issues, the next question is whether PSMA PET imaging could add to the detection of prostate cancer. Several retrospective case-report studies reported promising results regarding the improved diagnostic accuracy of prostatic PSMA PET/CT . Recently, in the PRIMARY trial, 291 men received successively MRI, PSMA PET/CT and systematic ± MRI-targeted biopsies. Despite similar PPV between imaging methods, the main advantage of PSMA was in men with equivocal MRI. Indeed, they found that 90% of csPCa was identified by PSMA PET/CT in this subgroup and paved the way for further investigation. This finding was confirmed in the most recent systematic review and meta-analysis.
The aim of this prospective study is to evaluate the added-value of PSMA PET in detecting prostate cancer in patients who are candidates for biopsy with equivocal MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with at least one lesion PI-RADS 3 | Other | Diagnostic Test: PSMA PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men ≥ 18 years of age
- Multiparametric MRI within the previous 6 months
- At least one lesion PI-RADS 3
- Able to provide written informed consent
Key exclusion criteria (8 listed)
- Previous prostate cancer diagnostic on MRI-targeted biopsy
- At least one lesion PI-RADS 4-5
- Negative MRI (PI-RADS 1-2)
- Previous treatment for prostate cancer 11
- Contraindication to PSMA PET and/or MRI and/or prostate biopsy
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 |
|---|---|---|
| PSMA PETpatients included in the study will perfom a PSMA PET | Diagnostic test | Patients with at least one lesion PI-RADS 3 |
Primary outcome
Percentage of patients with clinically significant prostate cancer detected by PSMA PET-targeted biopsy
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA PET in people with Multiparametric MRI and Lesion PI-RADS 3, run by Jules Bordet Institute at 1 site in Belgium.
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 5 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: looking for participants now, as of the sponsor's last update on 31 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain Diamand (003225413781, romain.diamand@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with clinically significant prostate cancer detected by PSMA PET-targeted biopsy (time frame: Baseline). 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 31 Mar 2025.