A Phase 2 interventional study of Gallium-68 THP-PSMA in Prostate Cancer, sponsored by Theragnostics Ltd. Completed at 4 sites in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-24.
Sponsored by Theragnostics Ltd · Phase 2, Interventional, and Diagnostic
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 49 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Theragnostics Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Group A: Adenocarcinoma of the prostate gland suitable for radical Tx.
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:
Group C: PCa and a diagnosis of BCR, previously treated with radical radiotherapy, being considered for radical salvage therapy (with curative intent).
Exclusion Criteria:
Group A:
Group B:
Group C:
Single intravenous administration of Gallium-68 THP-PSMA
Drug: Gallium-68 THP-PSMA
Subjects will undergo a Gallium-68 THP-PSMA scan in addition to standard of care monitoring. The results of this scan may influence the patient management plan.
Also known as: THG-001
Change in Patient Management
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.
Time frame: up to 3 months post PET/CT
Safety - Treatment Emergent Adverse Events
Safety was assessed by means of physical examination, vital signs, cardiovascular profile, performance status, laboratory evaluations (haematology, biochemistry, urinalysis and prostate-specific antigen), recording of concurrent illness/therapy and AEs. No dose limiting toxicity was defined in this study.
Time frame: Safety was assessed at screening, during the study and at Visit 4. AEs, regardless of relationship to study treatment, were recorded from the time of 68Ga-THP-PSMA administration until 30 days after the administration of 68Ga-THP-PSMA.
Recruitment Period June 18th 2018 to June 12th 2019.
| Milestone | Group A | Groups B and C |
|---|---|---|
| Started | 20 | 29 |
| Completed | 19 | 29 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Participants | Group A | Groups B and C | Full Analysis Set | Per Protocol Set |
|---|---|---|---|---|
| change in management plan | 6 | 15 | 21 | 21 |
| no change in management plan | 14 | 14 | 28 | 28 |
Safety was assessed by means of physical examination, vital signs, cardiovascular profile, performance status, laboratory evaluations (haematology, biochemistry, urinalysis and prostate-specific antigen), recording of concurrent illness/therapy and AEs. No dose limiting toxicity was defined in this study.
| number of subjects | Group A | Groups B and C | Safety Evaluable Population |
|---|---|---|---|
| Any TEAE | 2 | 3 | 5 |
| Any TEAE related to 68Ga-THP-PSMA | 1 | 1 | 2 |
| Any TEAE CTCAE Grade 3 or higher | 1 | 1 | 2 |
| Any related TEAE CTCAE Grade 3 or higher | 0 | 0 | 0 |
| Any TEAE with outcome of death | 0 | 0 | 0 |
| Any related TEAE with outcome of death | 0 | 0 | 0 |
| Any serious TEAE | 0 | 0 | 0 |
| Any serious TEAE related to 68Ga-THP-PSMA | 0 | 0 | 0 |
| Any TEAE leading to discontinuation from study | 0 | 0 | 0 |
| Any related TEAE leading to discontinuation | 0 | 0 | 0 |
Collected over Safety was assessed at screening, during the study and at Visit 4. AEs, regardless of relationship to study treatment, were recorded from the time of 68Ga-THP-PSMA administration until 30 days after the administration of 68Ga-THP-PSMA.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A | 0/20 (0%) | 0/20 (0%) | 2/20 (10%) |
| Groups B and C | 0/29 (0%) | 0/29 (0%) | 3/29 (10.3%) |
| Safety Evaluable Population | 0/49 (0%) | 0/49 (0%) | 5/49 (10.2%) |
| Event | Group A | Groups B and C | Safety Evaluable Population |
|---|---|---|---|
| SyncopeNervous system disorders | 1/20 | 0/29 | 1/49 |
| Confusional statePsychiatric disorders | 1/20 | 0/29 | 1/49 |
| VomitingGastrointestinal disorders | 1/20 | 0/29 | 1/49 |
| PruritisSkin and subcutaneous tissue disorders | 1/20 | 0/29 | 1/49 |
| Thermal BurnInjury, poisoning and procedural complications | 0/20 | 1/29 | 1/49 |
| PalpitationsCardiac disorders | 0/20 | 1/29 | 1/49 |
| DizzinessNervous system disorders | 0/20 | 1/29 | 1/49 |
| Sensory lossNervous system disorders | 0/20 | 1/29 | 1/49 |
| Catheter site rashGeneral disorders | 0/20 | 1/29 | 1/49 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/20 | 1/29 | 1/49 |
| Age, Categorical(Participants) | Group A | Groups B and C | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 14 | 22 |
| >=65 years | 12 | 15 | 27 |
| Sex: Female, Male(Participants) | Group A | Groups B and C | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 20 | 29 | 49 |
| Race (NIH/OMB)(Participants) | Group A | Groups B and C | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 3 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 5 | 12 |
| White | 13 | 21 | 34 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Group A | Groups B and C | Total |
|---|---|---|---|
| United Kingdom | 20 | 29 | 49 |
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