Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
138 participants
INTERVENTIONAL
2024-04-02
2029-02-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
NCT05141760
Prostate Cancer 18F-PSMA-1007 PET/CT Access Trial
NCT06489496
PSMA-PET/CT Registry
NCT05709535
A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer
NCT05712174
18F-PSMA-1007 PET/CT Imaging in Patients with Biochemically Recurrent or High-risk Prostate Cancer
NCT04733768
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Focal therapy is emerging as a new treatment strategy for appropriately selected men with localized prostate cancer. Focal therapy (also called partial gland ablation) is the concept of treating only where the tumor is believed to be located within the prostate, leaving normal healthy regions of the prostate untreated. Thus, focal therapy minimizes treatment side effects such as erectile dysfunction and incontinence, while providing good cancer control.
The foundation of performing oncologically sound partial gland ablation is possessing a high degree of diagnostic certainty that the tumor is limited to the region that is being treated and is not unknowingly present elsewhere in the gland. However, this is currently a major diagnostic challenge. The current diagnostic strategy for work-up of a patient for focal therapy is based on a pre-operative multiparametric MRI and combined targeted and systematic prostate biopsy showing intermediate risk prostate cancer localized to only one side of the prostate gland. This combination has been shown to accurately diagnose the final tumor grade in 96.5% of men. However, whole mount pathology data after radical prostatectomy shows that over 50% of cases that would pre-operatively have been deemed appropriate for focal therapy, which is a unilateral treatment, in fact harbour bilateral disease, which would mean that contralateral tumor would be inadvertently left untreated. Similarly, our group has shown that of the 35% of men who were found to have residual tumor after hemigland ablation of their prostate for unilateral disease, two-thirds of residual tumors were identified on the side contralateral to the ablative treatment. Therefore, our current gold standard pre-operative imaging and biopsy techniques are under staging many men who are undergoing focal therapy and a new paradigm is required to advance focal ablative treatments.
PSMA PET is a new imaging technique that uses a radioligand that binds to prostate specific membrane antigen (PSMA). PSMA is expressed at high levels in prostate cancer and the degree of expression correlates proportionately with tumor grade. A second generation PSMA PET radioligand, called 18F-PSMA-1007, has been used extensively at our site and possesses the key attributes of minimal urinary excretion, high resolution, and a half-life that as Gallium based radioligands. This makes 18F-PSMA-1007 an excellent candidate for improving the intraprostatic diagnostic accuracy of prostate cancer localization in patients considering focal therapy as a treatment option.
2. Research Question \& Objectives
Primary outcome:
The primary outcome is the 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 12 months after hemigland ablation.
Secondary outcomes:
* the number of men found to have bilateral disease on PSMA PET prior to hemi-gland ablation
* the number of men found to have bilateral disease on PSMA PET after hemi-gland ablation
* the rate of contralateral Gleason Grade Group 2 or greater prostate cancer at 12-month biopsy
* 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
* 5-year failure free survival defined as freedom from radical or systematic therapies, metastasis, prostate cancer specific and overall survivals.
* side effects of PSMA PET imaging
* health economics analysis of PSMA PET prior to hemigland ablation
* Quality of life outcomes will be assessed with validated questionnaires
3. Methods The investigators propose a multi-centre phase II randomized-controlled trial of 138 patients deemed appropriate for focal therapy based on current standard-of-care (SOC) diagnostic work-up to be randomized to receive 18F-PSMA-1007 imaging or no further imaging. Patients found to have bilateral disease by PSMA PET will be ineligible for focal therapy and will proceed with SOC treatments (radical prostatectomy or radiation therapy). Men with unilateral disease on PSMA PET as well as all men receiving no further imaging will undergo hemigland ablation followed by 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PSMA PET
These patients will have been diagnosed with unilateral prostate cancer by standard of care diagnostic tests deemed eligible and interested in focal therapy. These patients will be randomized to undergo a single \[18\]F-PSMA-1007 PET/CT or PET/MRI scan prior to focal therapy. If they are diagnosed with bilateral disease, they will be ineligible for focal therapy and be referred for radical therapy. Those with unilateral disease will then proceed to focal therapy. They will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation
Intravenous bolus injection of 4 MBq/kg +/- 10% of \[18\]F-PSMA-1007, up to a maximum of 400 MBq.
PSMA-1007 Positron Emission Tomography (PET) scan
Additional staging PET scan prior to focal therapy to focal therapy.
No Additional Imaging
These patients will have been diagnosed with unilateral prostate cancer by standard of care diagnostic tests deemed eligible and interested in focal therapy. These patients will undergo no further testing and will undergo focal therapy.
They will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation.
Intravenous bolus injection of 4 MBq/kg +/- 10% of \[18\]F-PSMA-1007, up to a maximum of 400 MBq.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PSMA-1007 Positron Emission Tomography (PET) scan
Additional staging PET scan prior to focal therapy to focal therapy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Clinical stage \< T2b
3. PSA \< 15
4. Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer
Exclusion Criteria
2. Weight \>250 kg (weight limitation of scanners)
3. Unable to lie flat for 30 minutes to complete the PET imaging
4. Lack of intravenous access
5. eGFR \< 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast
6. Prior androgen deprivation therapy or radiation therapy to prostate gland
50 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alberta
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Prostate Cancer Centre
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HREBA.CC-23-0330
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.