Clinical trial · Interventional
68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer
A Phase II, Open-label Study to Assess Safety and Clinical Utility of 68Ga-THP-PSMA PET/CT in Patients With High Risk Primary Prostate Cancer or Biochemical Recurrence After Radical Treatment (PRONOUNCED Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This will be an open-labelled, single centre study in the UK. The study group will include 60 patients with three groups of patients being studied. Group A will consist of 20 patients who have been newly diagnosed with primary high risk prostate cancer and are scheduled for radical prostatectomy surgery. Group B will consist of 20 patients with a diagnosis of BCR with previous radical prostatectomy, and are being considered for radical salvage therapy. Group C will consist of 20 patients with a diagnosis of BCR with previous radical radiotherapy (but no surgery), and are being considered for radical salvage therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium-68 THP-PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gallium-68 THP-PSMA
- description
- Single intravenous administration of Gallium-68 THP-PSMA
- interventionNames
- Drug: Gallium-68 THP-PSMA
Primary outcomes (1)
- measure
- Change in Patient Management
- timeFrame
- up to 3 months post PET/CT
- description
- The impact of 68Ga-THP-PSMA PET/CT on the management of patients with PCa was analysed by measuring the percentage of patients who had a change in management plan as a result of 68Ga-THP-PSMA PET/CT documented after scan, compared with their pre-scan management plan. A change status of 'Yes' was assigned if there was any difference in treatment options between the intended and revised management plans. A change status of 'No' was assigned if the intended and revised management plans remained identical. This endpoint was assessed in the full analysis set, but as a sensitivity analysis, was also assessed in the per protocol population in case there was a difference between the populations. As all 49 patients underwent a technically successful post-baseline scan, the full analysis set and per protocol populations were the same.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Group A: Adenocarcinoma of the prostate gland suitable for radical Tx. * Adenocarcinoma of Prostate * Gleason score 4+3 and above, or PSA \> 20 ng/mL or clinical stage \>T2C. * Suitable for surgical tx * No Hormone Therapy in last 3 months Group B: PCa and a diagnosis of BCR, previously treated with radical prostatectomy, being considered for radical salvage therapy (with curative intent). * Original diagnosis of PCa, treated with radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR based on: 1. Post RP: two consecutive rises in PSA and final PSA \>0.lng/ml OR Post RP: three consecutive rises in PSA. This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels). 2. Post RP: PSA doubling time of \~15 months OR PSA level 0.5 ng/ml. * No previous recurrences of PCa. * Consideration for radical salvage therapy. * Should not have received androgen-deprivation therapy within 3 months of screening. * No Hormone Therapy in last 3 months Group C: PCa and a diagnosis of BCR, previously treated with radical radiotherapy, being considered for radical salvage therapy (with curative intent). * The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR on the basis of: * Increase in PSA level \~2.0 ng/ml above the nadir level after radiotherapy (RT) or brachytherapy, no previous recurrences of BCR. * The subject is being considered for radical salvage therapy. * Should not have received androgen-deprivation therapy within 3 months of screening. * No hormone therapy within the past three months. Exclusion Criteria: Group A: * Prior Tx for Prostate Tumours * Gleason \< 4+3 * Hip prostheses * eGFR \<20 Group B: * Hormone Therapy in the last 3 months * Hip prostheses * eGFR \<20 Group C: * Hormone Therapy in the last 3 months * Hip prostheses * eGFR \<20
References
Publications (0)
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