xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06003556</url>
    </required_header>
    <id_info>
      <org_study_id>HREBA.CC-23-0140</org_study_id>
      <nct_id>NCT06003556</nct_id>
    </id_info>
    <brief_title>PSMA-Guided Ablation of the Prostate</brief_title>
    <acronym>P-GAP</acronym>
    <official_title>PSMA-Guided Ablation of the Prostate: A Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alberta</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Alberta</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this phase 2 multicenter randomized controlled trial is to study the accuracy of&#xD;
        second generation prostate specific membrane antigen (PSMA) positron emission tomography&#xD;
        (PET; utilizing 18F-PSMA-1007) compared to standard of care multiparametric MRI and MRI&#xD;
        targeted-prostate biopsy for staging in patients diagnosed with unilateral prostate cancer&#xD;
        who are eligible for focal therapy.&#xD;
  &#xD;
        The main question it aims to answer is:&#xD;
  &#xD;
        Can PSMA PET improve diagnostic accuracy for the primary staging of Prostate Cancer for&#xD;
        patients undergoing focal therapy thereby reducing residual and recurrence disease?&#xD;
  &#xD;
        Participants who are eligible by current standard of care diagnostic workup will undergo 1:1&#xD;
        randomization to PSMA PET scan or no further imaging. Those diagnosed with bilateral disease&#xD;
        by PSMA PET will be ineligible for focal therapy and be referred for radical therapy. Men&#xD;
        with unilateral disease on PSMA PET and those randomized to no further imaging will then&#xD;
        undergo focal therapy. All men undergoing focal therapy will receive PSMA PET, MRI, and&#xD;
        combined targeted and systematic biopsy 12 months after ablation. The primary outcome will be&#xD;
        the detection of Gleason Grade Group 2 or higher prostate cancer in men 12 months after&#xD;
        hemigland ablation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Background &amp; Rationale&#xD;
  &#xD;
             Focal therapy is emerging as a new treatment strategy for appropriately selected men&#xD;
             with localized prostate cancer. Focal therapy (also called partial gland ablation) is&#xD;
             the concept of treating only where the tumor is believed to be located within the&#xD;
             prostate, leaving normal healthy regions of the prostate untreated. Thus, focal therapy&#xD;
             minimizes treatment side effects such as erectile dysfunction and incontinence, while&#xD;
             providing good cancer control.&#xD;
  &#xD;
             The foundation of performing oncologically sound partial gland ablation is possessing a&#xD;
             high degree of diagnostic certainty that the tumor is limited to the region that is&#xD;
             being treated and is not unknowingly present elsewhere in the gland. However, this is&#xD;
             currently a major diagnostic challenge. The current diagnostic strategy for work-up of a&#xD;
             patient for focal therapy is based on a pre-operative multiparametric MRI and combined&#xD;
             targeted and systematic prostate biopsy showing intermediate risk prostate cancer&#xD;
             localized to only one side of the prostate gland. This combination has been shown to&#xD;
             accurately diagnose the final tumor grade in 96.5% of men. However, whole mount&#xD;
             pathology data after radical prostatectomy shows that over 50% of cases that would&#xD;
             pre-operatively have been deemed appropriate for focal therapy, which is a unilateral&#xD;
             treatment, in fact harbour bilateral disease, which would mean that contralateral tumor&#xD;
             would be inadvertently left untreated. Similarly, our group has shown that of the 35% of&#xD;
             men who were found to have residual tumor after hemigland ablation of their prostate for&#xD;
             unilateral disease, two-thirds of residual tumors were identified on the side&#xD;
             contralateral to the ablative treatment. Therefore, our current gold standard&#xD;
             pre-operative imaging and biopsy techniques are under staging many men who are&#xD;
             undergoing focal therapy and a new paradigm is required to advance focal ablative&#xD;
             treatments.&#xD;
  &#xD;
             PSMA PET is a new imaging technique that uses a radioligand that binds to prostate&#xD;
             specific membrane antigen (PSMA). PSMA is expressed at high levels in prostate cancer&#xD;
             and the degree of expression correlates proportionately with tumor grade. A second&#xD;
             generation PSMA PET radioligand, called 18F-PSMA-1007, has been used extensively at our&#xD;
             site and possesses the key attributes of minimal urinary excretion, high resolution, and&#xD;
             a half-life that as Gallium based radioligands. This makes 18F-PSMA-1007 an excellent&#xD;
             candidate for improving the intraprostatic diagnostic accuracy of prostate cancer&#xD;
             localization in patients considering focal therapy as a treatment option.&#xD;
  &#xD;
          2. Research Question &amp; Objectives&#xD;
  &#xD;
             Primary outcome:&#xD;
  &#xD;
             The primary outcome is the detection of any clinically significant prostate cancer&#xD;
             (defined as greater than or equal to Gleason Grade Group 2) at MRI-guided combined&#xD;
             targeted and systematic biopsy 12 months after hemigland ablation.&#xD;
  &#xD;
             Secondary outcomes:&#xD;
  &#xD;
               -  the number of men found to have bilateral disease on PSMA PET prior to hemi-gland&#xD;
                  ablation&#xD;
  &#xD;
               -  the number of men found to have bilateral disease on PSMA PET after hemi-gland&#xD;
                  ablation&#xD;
  &#xD;
               -  the rate of contralateral Gleason Grade Group 2 or greater prostate cancer at&#xD;
                  12-month biopsy&#xD;
  &#xD;
               -  the rate of contralateral Gleason Grade Group 2 or greater prostate cancer at final&#xD;
                  pathology in men undergoing radical prostatectomy after PSMA PET detected bilateral&#xD;
                  disease&#xD;
  &#xD;
               -  5-year failure free survival defined as freedom from radical or systematic&#xD;
                  therapies, metastasis, prostate cancer specific and overall survivals.&#xD;
  &#xD;
               -  side effects of PSMA PET imaging&#xD;
  &#xD;
               -  health economics analysis of PSMA PET prior to hemigland ablation&#xD;
  &#xD;
          3. Methods The investigators propose a multi-centre phase II randomized-controlled trial of&#xD;
             138 patients deemed appropriate for focal therapy based on current standard-of-care&#xD;
             (SOC) diagnostic work-up to be randomized to receive 18F-PSMA-1007 imaging or no further&#xD;
             imaging. Patients found to have bilateral disease by PSMA PET will be ineligible for&#xD;
             focal therapy and will proceed with SOC treatments (radical prostatectomy or radiation&#xD;
             therapy). Men with unilateral disease on PSMA PET as well as all men receiving no&#xD;
             further imaging will undergo hemigland ablation followed by PSMA PET, MRI, and combined&#xD;
             targeted and systematic biopsy 12 months after ablation. The primary outcome will be the&#xD;
             detection of Gleason Grade Group 2 or higher prostate cancer in men 12 months after&#xD;
             hemigland ablation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 29, 2023</start_date>
    <completion_date type="Anticipated">September 29, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 29, 2028</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Tumor Staging</measure>
      <time_frame>12 months after hemigland ablation.</time_frame>
      <description>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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Tumor Staging</measure>
      <time_frame>Prior to hemigland ablation - at study enrollment</time_frame>
      <description>The number of men found to have bilateral disease on PSMA PET prior to hemi-gland ablation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor Staging</measure>
      <time_frame>12 months after hemigland ablation.</time_frame>
      <description>The number of men found to have bilateral disease on PSMA PET after hemi-gland ablation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor Staging</measure>
      <time_frame>12 months after hemigland ablation.</time_frame>
      <description>The rate of contralateral Gleason Grade Group 2 or greater prostate cancer at time of biopsy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor Staging</measure>
      <time_frame>Through study completion, expected within 1 year of randomization</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor Staging</measure>
      <time_frame>5 years after hemigland ablation</time_frame>
      <description>5-year failure free survival defined as freedom from radical or systematic therapies, metastasis, prostate cancer specific and overall survivals.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Side Effects of Intervention</measure>
      <time_frame>Immediately after the imaging</time_frame>
      <description>Number of patients with Side effects of PSMA PET imaging</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Early Economic analysis</measure>
      <time_frame>12 months after hemigland ablation</time_frame>
      <description>Comparison of the direct health care system costs incurred by each patient in both trials arms at the 1 year mark after hemigland ablation. Health system resource utilisation data will be captured using the administrative data infrastructures of the health care systems hosting the study centres, combined with data from the study clinical case report form. Unit costs for all resources will be obtained from CIHI and health system specific cost databases.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post Trial Economic analysis</measure>
      <time_frame>Through Study Completion, completion by end of study at 5 year mark</time_frame>
      <description>Comparison of the direct health care system costs incurred by each patient in both trials arms at the 5 year mark after hemigland ablation at the time of study completion. Health system resource utilisation data will be captured using the administrative data infrastructures of the health care systems hosting the study centres, combined with data from the study clinical case report form. Unit costs for all resources will be obtained from CIHI and health system specific cost databases.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">138</enrollment>
    <condition>Prostate Cancer</condition>
    <condition>Localized Prostate Carcinoma</condition>
    <arm_group>
      <arm_group_label>PSMA PET</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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&#xD;
  Intravenous bolus injection of 4 MBq/kg +/- 10% of [18]F-PSMA-1007, up to a maximum of 400 MBq.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Additional Imaging</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.&#xD;
  They will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation.&#xD;
  Intravenous bolus injection of 4 MBq/kg +/- 10% of [18]F-PSMA-1007, up to a maximum of 400 MBq.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>PSMA-1007 Positron Emission Tomography (PET) scan</intervention_name>
      <description>Additional staging PET scan prior to focal therapy to focal therapy.</description>
      <arm_group_label>PSMA PET</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age &gt; 50&#xD;
  &#xD;
            2. Clinical stage &lt; T2b&#xD;
  &#xD;
            3. PSA &lt; 15&#xD;
  &#xD;
            4. Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade&#xD;
               Group 2 or 3 prostate cancer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Unable to obtain consent&#xD;
  &#xD;
            2. Weight &gt;250 kg (weight limitation of scanners)&#xD;
  &#xD;
            3. Unable to lie flat for 30 minutes to complete the PET imaging&#xD;
  &#xD;
            4. Lack of intravenous access&#xD;
  &#xD;
            5. eGFR &lt; 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast&#xD;
  &#xD;
            6. Prior androgen deprivation therapy or radiation therapy to prostate gland&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Adam Kinnaird, MD, PhD</last_name>
      <phone>(780) 407-5800</phone>
      <phone_ext>321</phone_ext>
      <email>ask@ualberta.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alexander Tamm, MD</last_name>
      <email>astamm@ualberta.ca</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Alberta</investigator_affiliation>
      <investigator_full_name>Adam Kinnaird</investigator_full_name>
      <investigator_title>Assistant Professor, Faculty of Medicine &amp; Dentistry - Surgery Dept</investigator_title>
    </responsible_party>
    <keyword>Prostate Cancer</keyword>
    <keyword>PSMA Pet</keyword>
    <keyword>Focal Therapy</keyword>
    <keyword>Localized Prostate Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06003556
  org study id: HREBA.CC-23-0140
  nct id: NCT06003556
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  1. Background & Rationale
  
             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
  
          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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Outcomes Assessor)
  measure: Tumor Staging
  time frame: 12 months after hemigland ablation.
  description: 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
  measure: Tumor Staging
  time frame: Prior to hemigland ablation - at study enrollment
  description: The number of men found to have bilateral disease on PSMA PET prior to hemi-gland ablation
  measure: Tumor Staging
  time frame: 12 months after hemigland ablation.
  description: The number of men found to have bilateral disease on PSMA PET after hemi-gland ablation
  measure: Tumor Staging
  time frame: 12 months after hemigland ablation.
  description: The rate of contralateral Gleason Grade Group 2 or greater prostate cancer at time of biopsy
  measure: Tumor Staging
  time frame: Through study completion, expected within 1 year of randomization
  description: 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
  measure: Tumor Staging
  time frame: 5 years after hemigland ablation
  description: 5-year failure free survival defined as freedom from radical or systematic therapies, metastasis, prostate cancer specific and overall survivals.
  measure: Side Effects of Intervention
  time frame: Immediately after the imaging
  description: Number of patients with Side effects of PSMA PET imaging
  measure: Early Economic analysis
  time frame: 12 months after hemigland ablation
  description: Comparison of the direct health care system costs incurred by each patient in both trials arms at the 1 year mark after hemigland ablation. Health system resource utilisation data will be captured using the administrative data infrastructures of the health care systems hosting the study centres, combined with data from the study clinical case report form. Unit costs for all resources will be obtained from CIHI and health system specific cost databases.
  measure: Post Trial Economic analysis
  time frame: Through Study Completion, completion by end of study at 5 year mark
  description: Comparison of the direct health care system costs incurred by each patient in both trials arms at the 5 year mark after hemigland ablation at the time of study completion. Health system resource utilisation data will be captured using the administrative data infrastructures of the health care systems hosting the study centres, combined with data from the study clinical case report form. Unit costs for all resources will be obtained from CIHI and health system specific cost databases.
  arm group label: PSMA PET
  arm group type: Experimental
  description: 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.
  arm group label: No Additional Imaging
  arm group type: No Intervention
  description: 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.
  intervention type: Diagnostic Test
  intervention name: PSMA-1007 Positron Emission Tomography (PET) scan
  description: Additional staging PET scan prior to focal therapy to focal therapy.
  arm group label: PSMA PET
  criteria: 
  gender: Male
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Adam Kinnaird, MD, PhD
  phone: (780) 407-5800
  phone ext: 321
  email: ask@ualberta.ca
  last name: Alexander Tamm, MD
  email: astamm@ualberta.ca
  responsible party type: Principal Investigator
  investigator affiliation: University of Alberta
  investigator full name: Adam Kinnaird
  investigator title: Assistant Professor, Faculty of Medicine & Dentistry - Surgery Dept
  mesh term: Prostatic Neoplasms
  sharing ipd: No