The Added-value of PSMA PET in Detecting Clinically Significant Prostate Cancer Lesions in Patients Undergoing MRI-targeted Biopsy. (PANDORA)

NCT06867588 | Recruiting

• 1 other identifier: IJBPANDORA
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

PSMA PET; MRI-targeted biopsy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with clinically significant prostate cancer detected by PSMA PET-targeted biopsy

  Baseline

Study Arms (1)

Patients with at least one lesion PI-RADS 3

OTHER

Diagnostic Test: PSMA PET

Interventions

PSMA PET DIAGNOSTIC_TEST

patients included in the study will perfom a PSMA PET

Patients with at least one lesion PI-RADS 3

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men ≥ 18 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

Central Study Contacts

Romain Diamand

CONTACT

003225413781; romain.diamand@hubruxelles.be

Loubna Taraji

CONTACT

003225413781; loubna.taraji@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 10, 2025
• Study Start: October 17, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2025

Record last verified: 2025-02

Locations

BE (1)