PSMA-Guided Ablation of the Prostate
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age50+
SponsorUniversity of Alberta
About this trial
The goal of this phase 2 multicenter randomized controlled trial is to study the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007) compared to standard of care multiparametric MRI and MRI targeted-prostate biopsy for staging in patients diagnosed with unilateral prostate cancer who are eligible for focal therapy.
The main question it aims to answer is:
Can PSMA PET improve diagnostic accuracy for the primary staging of Prostate Cancer for patients undergoing focal therapy thereby reducing residual and recurrence disease?
Participants who are eligible by current standard of care diagnostic workup will undergo 1:1 randomization to PSMA PET scan or no further imaging. Those diagnosed with bilateral disease by PSMA PET will be ineligible for focal therapy and be referred for radical therapy. Men with unilateral disease on PSMA PET and those randomized to no further imaging will then undergo focal therapy. All men undergoing focal therapy will receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation. The primary outcome will be the detection of Gleason Grade Group 2 or higher prostate cancer in men 12 months after hemigland ablation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 50
Clinical stage < T2b
PSA < 15
Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer
Disqualifiers
Unable to obtain consent
Weight >250 kg (weight limitation of scanners)
Unable to lie flat for 30 minutes to complete the PET imaging
Lack of intravenous access
Trial design
Design model
Parallel
Treatments tested in this trial
PSMA-1007 Positron Emission Tomography (PET) scan
Diagnostic testAdditional staging PET scan prior to focal therapy to focal therapy.
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: PSMA PETExperimental treatment 1 intervention
Group B: No Additional ImagingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Tumor Staging- Detection of any clinically significant prostate cancer
Detection of any clinically significant prostate cancer (defined as greater than or equal to Gleason Grade Group 2) at MRI-guided combined targeted and systematic biopsy
Time frame
12 months after hemigland ablation.Secondary outcomes
1
Tumor Staging - bilateral disease on PSMA PET prior to hemi-gland ablation
The number of men found to have bilateral disease on PSMA PET prior to hemi-gland ablation
Time frame
Prior to hemigland ablation - at study enrollment2
Tumor Staging - bilateral disease on PSMA PET after hemi-gland ablation
The number of men found to have bilateral disease on PSMA PET after hemi-gland ablation
Time frame
12 months after hemigland ablation.3
Tumor Staging- rate of contralateral Gleason Grade Group 2 or greater prostate cancer at biopsy
The rate of contralateral Gleason Grade Group 2 or greater prostate cancer at time of biopsy
Time frame
12 months after hemigland ablation.4
Tumor Staging - rate of contralateral Gleason Grade Group 2 or greater prostate cancer at final pathology
The rate of contralateral Gleason Grade Group 2 or greater prostate cancer at final pathology in men undergoing radical prostatectomy after PSMA PET detected bilateral disease
Time frame
Through study completion, expected within 1 year of randomizationSponsors and contacts
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Source ClinicalTrials.gov