E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic prostate cancer |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071119 |
E.1.2 | Term | Hormone-dependent prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
To demonstrate flare in PSMA expression 2-3 weeks after initiation of androgen deprivation therapy in metastatic lesions as seen in previous clinical trial (clinicaltrials.gov identifier: NCT03313726) |
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E.2.2 | Secondary objectives of the trial |
To study if metastatic lesions with and without PSMA-flare behave differently in repeated 18F-PSMA PET-CT at the time of CRPC
To study if metastatic lesions with and without PSMA-flare behave differently in contrast-enhanced whole body CT during the follow-up |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Substudy 1: Comparison of metastatic load using 18F-PSMA PET-CT and 18F-FDG PET-CT in treatment naive metastatic prostate cancer Objective: to determine if metastatic lesions with and without PSMA-flare after ADT show a different metabolic behaviour on FDG-PET
Substudy 2: Effect of chemoterapy or local radiotherapy on PSMA expression in castration sensitive metastatic prostate cancer Objective: to determine the effect of chemotherapy or local treatment with radiotherapy on PSMA expression 3 months after the end of therapy
Substudy 3: Total androgen profile during the evolution of metastatic prostate cancer Objective: to determine the androgen profile by repeated total androgen measurements every six months from diagnosis to the developement of CRPC |
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E.3 | Principal inclusion criteria |
- Age: 40 to 85 years old - Language spoken: Finnish - Diagnosis: Histologically confirmed adenocarcinoma of prostate - Adequate histological sampling consisting of at least 3 biopsy samples from each lobe - No previous surgical, radiation or endocrine treatment for prostate carcinoma - Clinical stage: - T1c-T4NanyM1 - Serum creatinine ≤ 1,5 x ULN - Mental status: Patients must be able to understand the meaning of the study - Informed consent: The patient must sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff
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E.4 | Principal exclusion criteria |
- Previous PC treatment - Uncontrolled serious infection - Prior usage of 5-ARI medication in past 12 months
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E.5 End points |
E.5.1 | Primary end point(s) |
comparison of mean increase in SUVmax in F-PSMA-PET between bony lesions and prostatic lesions after initiation of ADT |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
to classify metastatic lesions into those with PSMA-flare and those without and then determine their potential to progress during the follow-up until CRPC |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
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 | No |
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 | No |
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 | No |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |