E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
High Risk Primary Prostate Cancer or Biochemical Recurrence after Radical treatment |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
Evaluation of safety of 68Ga-PSMA in patients with prostate cancer. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 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). |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in patient management as a result of 68Ga-PSMA PET documented after scan, compared with pre-scan management plan. |
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E.5.1.1 | 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. |
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E.5.2 | Secondary end point(s) |
Adverse events: Clinically significant changes in heart rate, blood pressure, ECG, urine analysis and baseline serum haematology and biochemistry profile. |
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E.5.2.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Evaluated against Phase 1 68Ga-THP-PSMA data and existing standard of care data |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 30 |