Recruiting
Phase 2

PSMA PET

Sponsor:

University of Alberta

Code:

NCT06003556

Conditions

Prostate Cancer

Localized Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Interventions

PSMA-1007 Positron Emission Tomography (PET) scan

Study Details

Brief 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 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.

Conditions

Prostate Cancer

Localized Prostate Carcinoma

Study ID

NCT06003556

Start date

Apr 2, 2024

Status verified date

Jun, 2026

Completion date

Feb 26, 2029

Anticipated

Primary completion date

Feb 26, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age > 50
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:

1. Unable to obtain consent
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

Study Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

Interventions

PSMA-1007 Positron Emission Tomography (PET) scan

Additional staging PET scan prior to focal therapy to focal therapy.

Primary outcome measure

  • Tumor Staging- Detection of any clinically significant prostate cancer [ Time Frame: 12 months after hemigland ablation. ]

Central Contacts and Locations

Central contacts

Adam Kinnaird, MD, PhD

(780) 407-5800ask@ualberta.ca

Alexander Tamm, MD

astamm@ualberta.ca

Locations

Prostate Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2V 1P9

Contacts

Arjuni Seevaratnam

Arjuni.s@prostatecancercentre.ca

Principal Investigator:

Bimal Bhindi, MD

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada, T5H 3V9

Contacts

Alexander Tamm, MD

780-407-6810astamm@ualberta.ca

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Alexander Tamm, MD

780-407-6810astamm@ualberta.ca

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Jenna Hiemstra

416-946-4501Jenna.Hiemstra2@uhn.ca

Principal Investigator:

Nathan Perlis, MD

More Information

Sponsor

University of Alberta

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • Prostate Cancer
  • PSMA Pet
  • Focal Therapy
  • Localized Prostate Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-03.