68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer
- Registration Number
- NCT03617588
- Lead Sponsor
- Theragnostics Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 49
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:
- 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).
- 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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gallium-68 THP-PSMA Gallium-68 THP-PSMA Single intravenous administration of Gallium-68 THP-PSMA
- Primary Outcome Measures
Name Time Method Change in Patient Management up to 3 months post PET/CT 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.
- Secondary Outcome Measures
Name Time Method Safety - Treatment Emergent Adverse Events 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. 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.
Trial Locations
- Locations (4)
St Bartholomew's Hospital (PIC)
🇬🇧London, United Kingdom
Royal Free Hospital (PIC)
🇬🇧London, United Kingdom
University College Hospital London
🇬🇧London, United Kingdom
Guy's and St Thomas' Hospital (PIC)
🇬🇧London, United Kingdom