68Ga-THP-PSMA PET/CT imaging in high risk primary prostate cancer and biochemical recurrence of prostate cancer.
- Conditions
- High Risk Primary Prostate Cancer or Biochemical Recurrence after Radical treatmentTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-005010-59-GB
- Lead Sponsor
- Theragnostics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method