High Risk Primary Prostate Cancer or Biochemical Recurrence after Radical treatment
Conditions
Interventions
Product Name: 68Ga-THP-PSMA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not yet assigned
Current Sponsor code: 68Ga-THP-PSMA
Sponsors
Theragnostics Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Group A: Inclusion Criteria - The patient is a male equal to/ over 18 years old. - Histologically proven adenocarcinoma of the prostate gland. - Gleason score 4+3 and above, or PSA >20 ng/mL or clinical stage >T2c. - The patient is to be suitable for surgical treatment as part of their standard of care management. - The patient is able and willing to comply with study procedures, and signature and dating of the informed consent form (ICF) is obtained before any study-related procedure is performed. - The patient has a normal or clinically acceptable medical history and vital signs findings at screening (up to 4 weeks before administration of 68Ga-THP-PSMA). - The patient should not have received hormone therapy related to PCa within the past 3 months (other types of hormone therapy are not excluded). - The patient’s Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2. Group B: Inclusion Criteria - The patient is a male equal to or over 18 years old. - The patient has had an original diagnosis of PCa, underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR based on: - Post RP: 2 consecutive rises in PSA with a 3-month interval in between reads and final PSA >0.l ng/mL or PSA level 0.5 mg/mL at time of recruitment. The PSA doubling time will be calculated using the Memorial Sloan Kettering Cancer Center nomogram based on a minimum of 2 PSA levels within 12 months of screening, taken after the last recorded nadir PSA available at time of screening. - The patient has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR. - The patient is being considered for radical salvage therapy. - The patient is able and willing to comply with study procedures, and signature and dating of the ICF is obtained before any study-related procedure is performed. - The patient’s ECOG performance status is 0 to 2. The patient should not have received androgen-deprivation therapy within 3 months of screening. - The patient has a normal or clinically acceptable medical history and vital signs findings at screening (up to 14 days before administration of 68Ga-THP-PSMA). - The patient should not have received hormone therapy related to PCa within the past 3 months (other types of hormone therapy are not excluded). Group C: Inclusion Criteria - The subject is a male equal to or over 18 years old. - 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: o Increase in PSA level ~2.0 ng/mL above the nadir level after radiotherapy or brachytherapy31. - The patient has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR. - The patient is being considered for radical salvage therapy. - The patient is able and willing to comply with study procedures, and signature and dating of the ICF is obtained before any study-related procedure is performed. - The patient’s ECOG performance status is
Exclusion criteria
Exclusion criteria: Group A exclusion criteria - Any prior treatment for prostate gland tumours. - The patient has received, or is scheduled to receive, another investigational medicinal product (IMP) from 1 month before to 1 week after administration of 68Ga-THP-PSMA injection. - The patient has known hypersensitivity to 68Ga-THP-PSMA injection or any of its constituents. - The patient has been previously included in this study. - Estimated glomerular filtration rate <20 mL/min per 1.73 m2 as assessed by local practices. Group B and Group C exclusion criteria - The patient has been previously included in this study. - The patient has received, or is scheduled to receive, another IMP from 1 month before to 1 week after administration of 68Ga-THP-PSMA injection. - The patient has known hypersensitivity to 68Ga-THP-PSMA injection or any of its constituents. - Hormone therapy within the past 3 months. - Estimated glomerular filtration rate <20 mL/min per 1.73 m2 as assessed by local practices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: It is recommended that this outpatient appointment is scheduled approximately 2 weeks after the 68Ga-THP-PSMA PET/CT scan (Visit 2), although a window of 0 to 6 weeks is permitted depending on local clinical practice. The clinical team will then record whether the pre-scan management plan will be unchanged or altered based on the new information provided by the 68Ga-THP-PSMA PET/CT and the reason for the decision. ; Main Objective: Evaluation of 68GA-PSMA PET impact on the management of patients with prostate cancer in the setting of: i) biochemical recurrence in patients treated with radical prostatectomy ii) biochemical recurrence in patients treated with radiotherapy iii) newly diagnosed high risk prostate cancer ;Secondary Objective: Evaluation of safety of 68Ga-PSMA in patients with prostate cancer.;Primary end point(s): Change in patient management as a result of 68Ga-PSMA PET documented after scan, compared with pre-scan management plan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events: Clinically significant changes in heart rate, blood pressure, ECG, urine analysis and baseline serum haematology and biochemistry profile.; Timepoint(s) of evaluation of this end point: Visit 2 (within 4 weeks of Visit 1): Review of AE/SAEs will be performed immediately post-scan. In the absence of any adverse events, the patient can be discharged 2 hours post scan. Visit 3(the next working day after after 68Ga-THP-PSMA PET/CT): A review of AEs will be performed via telephone consultation. Visit 4 (Outpatient appointment - It is recommended that this outpatient appointment is scheduled approximately 2 weeks after the 68Ga-THP-PSMA PET/CT scan (Visit 2)): Review of adverse events since discharge. | — |
Countries
United Kingdom
Contacts
Public ContactMarie Moores
Theradex Oncology
Outcome results
None listed