Prostate CancerPhase 2P-GAPNCT06003556
PSMA-Guided Ablation of the Prostate
A Phase 2 study testing PSMA-1007 Positron Emission Tomography (PET) scan in people with Prostate Cancer and Localized Prostate Carcinoma, run by University of Alberta at 4 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer, Localized Prostate Carcinoma
- What is being tested?
- PSMA-1007 Positron Emission Tomography (PET) scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 4 sitesCanada
- Study dates
- 2 Apr 2024to 26 Feb 2029
- Phase
- Phase 2
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50
- Clinical stage < T2b
- PSA < 15
- Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer
Who cannot join
- 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
- eGFR < 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast
- Prior androgen deprivation therapy or radiation therapy to prostate gland
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexander Tamm, MD contact
Canada4 sites, 4 recruiting
- Recruiting
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9
Arjuni Seevaratnam, Arjuni.s@prostatecancercentre.ca
Bimal Bhindi, MD
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Alexander Tamm, MD, 780-407-6810, astamm@ualberta.ca
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Alexander Tamm, MD, 780-407-6810, astamm@ualberta.ca
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Jenna Hiemstra, 416-946-4501 ext. 3381, Jenna.Hiemstra2@uhn.ca
Nathan Perlis, MD
About this study
Official title: PSMA-Guided Ablation of the Prostate: A Multicenter Randomized Controlled 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:
Read more
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.
Read the detailed description
- 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.
- 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
- 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
- Prostate Cancer, Localized Prostate Carcinoma
- Being tested
- PSMA-1007 Positron Emission Tomography (PET) scan
- Keywords
- Prostate Cancer, PSMA Pet, Focal Therapy, Localized Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA-1007 Positron Emission Tomography (PET) scanDiagnostic test
Additional staging PET scan prior to focal therapy to focal therapy.
| Study group | Role | What they receive |
|---|---|---|
| PSMA PET | Experimental | 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. Receives: Diagnostic Test: PSMA-1007 Positron Emission Tomography (PET) scan |
| No Additional Imaging | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after hemigland ablation.
Secondary outcomes (12)
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
Measured: Prior to hemigland ablation - at study enrollment
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
Measured: 12 months after hemigland ablation.
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
Measured: 12 months after hemigland ablation.
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
Measured: Through study completion, expected within 1 year of randomization
Tumor Staging - 5-year failure free survival
5-year failure free survival defined as freedom from radical or systematic therapies, metastasis, prostate cancer specific and overall survivals.
Measured: 5 years after hemigland ablation
Side Effects of Intervention
Number of patients with Side effects of PSMA PET imaging
Measured: Immediately after the imaging
Early Economic analysis
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.
Measured: 12 months after hemigland ablation
Post Trial Economic analysis
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.
Measured: Through Study Completion, completion by end of study at 5 year mark
Quality of Life Outcomes - EPIC-26
The EPIC-26 is a short form questionnaire designed to measure Quality of Life (QOL) issues in patients with prostate cancer. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better Health Related QOL.
Measured: Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after
Quality of Life Outcomes - AUA Symptom Score
The AUA Symptom Score evaluates impact and severity of urinary symptoms in patients with benign prostatic hyperplasia (BPH). The AUA Symptom Score ranges from 0 to 35, with higher scores indicating more severe symptoms.
Measured: Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after
Quality of Life Outcomes - IIEF 5
The IIEF-5 is a short form version of a patient-reported outcome measure to evaluate erectile dysfunction and other sexual problems in men. THE IIEF-5 scale ranges from 5-25 with a higher score indicating less severe symptoms.
Measured: Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after
Quality of Life Outcomes - EQ-5D-5L
The EQ-5D-5L questionnaire is a self-assessed, health-related, quality of life questionnaire that measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The questionnaire can be used to derive a summary index score, which ranges from 0.000 (death) to 1.000 (perfect health).
Measured: Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start2 Apr 2024
- Primary completion26 Feb 2029 (estimated)
- Study completion26 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003556
- Sponsor's protocol ID
- HREBA.CC-23-0330
- Acronym
- P-GAP
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA-Guided Ablation of the Prostate: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06003556
- Acronym / sponsor ID
- P-GAP / HREBA.CC-23-0330
- Conditions
- Prostate Cancer, Localized Prostate Carcinoma
- Keywords
- Prostate Cancer, PSMA Pet, Focal Therapy, Localized Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 26 Feb 2029 (estimated)
- Study completion
- 26 Feb 2029 (estimated)
- First posted
- 22 Aug 2023 (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.
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.
Detailed description
- 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.
- 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
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSMA PET | Experimental | Diagnostic Test: PSMA-1007 Positron Emission Tomography (PET) scanThese 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. |
| No Additional Imaging | No intervention | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 50
- Clinical stage < T2b
- PSA < 15
- Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer
Key exclusion criteria (6 listed)
- 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
- eGFR < 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast
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-1007 Positron Emission Tomography (PET) scanAdditional staging PET scan prior to focal therapy to focal therapy. | Diagnostic test | PSMA PET |
Primary outcome
Tumor Staging- Detection of any clinically significant prostate cancer
Time frame: 12 months after hemigland ablation.
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 secondary outcomes
Tumor Staging - bilateral disease on PSMA PET prior to hemi-gland ablation
Time frame: Prior to hemigland ablation - at study enrollment
Tumor Staging - bilateral disease on PSMA PET after hemi-gland ablation
Time frame: 12 months after hemigland ablation.
Tumor Staging- rate of contralateral Gleason Grade Group 2 or greater prostate cancer at biopsy
Time frame: 12 months after hemigland ablation.
Tumor Staging - rate of contralateral Gleason Grade Group 2 or greater prostate cancer at final pathology
Time frame: Through study completion, expected within 1 year of randomization
Tumor Staging - 5-year failure free survival
Time frame: 5 years after hemigland ablation
Side Effects of Intervention
Time frame: Immediately after the imaging
Early Economic analysis
Time frame: 12 months after hemigland ablation
Post Trial Economic analysis
Time frame: Through Study Completion, completion by end of study at 5 year mark
Quality of Life Outcomes - EPIC-26
Time frame: Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after
Quality of Life Outcomes - AUA Symptom Score
Time frame: Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after
Quality of Life Outcomes - IIEF 5
Time frame: Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after
Quality of Life Outcomes - EQ-5D-5L
Time frame: Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Alexander Tamm, MD contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PSMA-1007 Positron Emission Tomography (PET) scan in people with Prostate Cancer and Localized Prostate Carcinoma, run by University of Alberta at 4 sites in Canada.
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 4 inclusion and 6 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Adam Kinnaird, MD, PhD ((780) 407-5800 ext. 321, ask@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Staging- Detection of any clinically significant prostate cancer (time frame: 12 months after hemigland ablation.). 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 3 Jun 2026.