E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Suspicion of prostate cancer recurrence after previous definitive treatment, based on American Society for Radiation Oncology (ASTRO) criteria of 3 consecutive PSA rises and/or ASTRO/Phoenix criteria of PSA nadir above 2.0 ng/mL after radiotherapy or cryotherapy and/or greater than 0.2 ng/mL after prostatectomy |
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E.1.1.1 | Medical condition in easily understood language |
Patients with prostate cancer in whom the treating physician suspect recurrence. All patients in this trial have received an effective and successful initial treatment the after diagnosis. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
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 | 10060862 |
E.1.2 | Term | Prostate cancer |
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 | 10036911 |
E.1.2 | Term | Prostate cancer recurrent |
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 show, in an independent assessment by 3 readers blinded to clinical data and tracer, the superiority of F-18-PSMA-1007 over F-18-Fluorocholine regarding the detection rate of metastatic prostate cancer lesions (patient-based analysis) |
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E.2.2 | Secondary objectives of the trial |
1. to compare the detection rate of the clinical investigator for F-18-PSMA-1007 and F-18-Fluorocholine for metastatic prostate cancer lesions (patient-based analysis) 2. to assess sensitivity, specificity, accuracy, positive and negative predictive value of F-18-PSMA-1007 and F-18-Fluorocholine for prostate cancer lesions (regionbased analysis: prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, bone, organ metastases; reads by investigator and 3 independent blinded readers) 3. to assess the impact on diagnostic thinking, therapeutic decision making, and adequacy of therapy changes (F-18-PSMA-1007 and F-18-Fluorocholine) 4. to assess the safety profile of F-18 -PSMA-1007 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. male with original diagnosis of prostate carcinoma with prior definitive therapy 2. suspicion of recurrence 3. life expectancy of 6 months or more as judged by the investigator 4. willing and able to undergo all study procedures 5. informed consent in writing (dated and signed) |
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E.4 | Principal exclusion criteria |
1. age: less than18 years 2. contraindications for F-18-Fluorocholine 3. contraindications for any of the ingredients of F-18-PSMA-1007 4. close affiliation with the investigational site; e.g. first-degree relative of the investigator 5. at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial 6. having been previously enrolled in this clinical trial 7. mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial 8. being clinically unstable or requiring emergency treatment |
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E.5 End points |
E.5.1 | Primary end point(s) |
recurrence rate as detected by the two PET tracers (patient-based, independent read) using an expert panel as standard of truth |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at the end of the trial, after completion of 6 months followup in all patients who complete the study |
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E.5.2 | Secondary end point(s) |
1. detection rate of prostate cancer lesions (patient-based: local investigator) 2. per body region: sensitivity and specificity for detection of prostate cancer lesions (local investigators and independent read; expert panel assessment as standard of truth) 3. diagnostic thinking and therapeutic decisions (local investigators and expert panel) 4. appropriateness of therapeutic decisions (expert panel) 5. adverse events / safety 6. Dosimetry estamtes for F-18-PSMA-1007 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at the end of the trial, after completion of 6 months followup in all patients who complete the study |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
France |
Switzerland |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |