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NCT06003556: P-GAP
PSMA-Guided Ablation of the Prostate
Phase 2 trial testing PSMA-1007 Positron Emission Tomography (PET) scan in Prostate Cancer in 138 participants. Currently enrolling.
26 February 2029
Quick facts
| Lead sponsor | University of Alberta |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 138 |
| Start date | 2 April 2024 |
| Primary completion | 26 February 2029 |
| Estimated completion | 26 February 2029 |
| Sites | 3 locations across Canada |
Drugs / interventions tested
- PSMA-1007 Positron Emission Tomography (PET) scan
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Localized Prostate Carcinoma — all drugs for Localized Prostate Carcinoma →
Sponsor
University of Alberta
Who can join
50 and older, male only, with Prostate Cancer or Localized Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Beyond fluorodeoxyglucose: Molecular imaging of cancer in precision medicine.
Juweid ME, Al-Qasem SF, Khuri FR, Gallamini A, et al · · 2025 · cited 9× · PMID 40183513 · DOI 10.3322/caac.70007
Verify or expand the search:
- PubMed search for NCT06003556
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
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- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06003556 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alberta
- Last refreshed: 4 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06003556.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing