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A clinical trial to find out if using the findings from PSMA PET scans to escalate treatment can improve cancer control in patients with high-risk prostate cancer

A multicentre randomised controlled trial to assess the clinical effectiveness and cost-effectiveness of PSMA PET-CT imaging to stage newly diagnosed high risk prostate cancer compared to standard of care CT and bone scan imaging

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78360465
Enrollment
476
Registered
2026-01-27
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer

Interventions

The participant will undergo three imaging tests: CT, bone scan, and PSMA PET-CT. After completing all imaging tests, they will be randomly allocated to one of two groups. The participant will have an

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed prostate adenocarcinoma 2. NCCN high-risk cancer defined as any of: 2.1. Stage >/= cT3 OR 2.2. ISUP Grade Group 4 and 5 (or Gleason score 8, 9 or 10) OR 2.3. PSA >20 ng/ml 3. M0 on standard prostate MRI 4. Patient suitable for standard local therapy (surgery or radiotherapy with curative intent) to the prostate as deemed by clinical team 5. Age >= 18 years

Exclusion criteria

Exclusion criteria: 1. M1 on standard prostate MRI 2. Unable to undergo prostate/pelvic MRI, CT-TAP, radio-isotope bone-scan, or PSMA PET-CT 3. Unable to receive iodinated contrast (eg contrast allergy, significant renal impairment) 4. Previous imaging, other than screening pelvic MRI, for the primary purpose of staging pelvic nodal or distant metastatic disease of prostate cancer within 8 weeks prior to randomisation 5. Previous local or systemic (including any ADT/ARTA/docetaxel chemotherapy) treatment of prostate cancer (5-alpha reductase inhibitors are permitted) 6. Other malignancies diagnosed in previous 2 years (except non-melanoma skin cancer) 7. Variant/non-adenocarcinoma histology (e.g., spindle cell, neuroendocrine) 8. Already commenced hormone treatment

Countries

United Kingdom

Contacts

Public ContactSamuel;. Morris;General clinical enquires

;

s.j.morris@imperial.ac.uk;imperial.avidity@nhs.net-;-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026