Phase 2
N=49
68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03617588 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Change in Patient Management — 6; 15; 21; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gallium-68 THP-PSMA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Theragnostics Ltd
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient Management |
6; 15; 21; 21; 14; 14 | — |
| SECONDARY Safety - Treatment Emergent Adverse Events |
2; 3; 5; 1; 1; 2 | — |
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.
Eligibility Criteria
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:
- 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.
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
Data sourced from ClinicalTrials.gov (NCT03617588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.