E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with prostate cancer, with a PSA recurrence of ˃
0.2 ng/ml after prostatectomy, and who are going to receive radiotherapy to the prostate bed. |
Patienter med prostatacancer, vilka återfallit i sin sjukdom definierat som en förhöjning av PSA-värdet med 0.2 ng/ml efter resektion av prostata, och som skall erhålla strålbehandling mot prostatabädden. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with prostate cancer, with a PSA recurrence of ˃
0.2 ng/ml after prostatectomy, and who are going to receive radiotherapy to the prostate bed. |
Patienter med prostatacancer, vilka återfallit i sin sjukdom definierat som en förhöjning av PSA-värdet med 0.2 ng/ml efter resektion av prostata, och som skall ha strålbehandling mot prostatabädden. |
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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 | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066489 |
E.1.2 | Term | Progression of prostate cancer |
E.1.2 | System Organ Class | 100000004864 |
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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 |
The ability of 68-Ga-PSMA-PET to identify relapse of prostate cancer in patients with recurrence after prostatectomy. |
Möjligheten att med hjälp av 68-Ga-PSMA-PET identifiera återfallslokal av prostatacancer hos patienter som erhåller strålbehandling för återfall av cancer efter radikal prostatektomi. |
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E.2.2 | Secondary objectives of the trial |
- PSA response (during treatment)
- PSA response (at 3, 6, 9, 12, and 24 months post treatment
- Overall survival
- Toxicity
- Quality of life
- Prevalence of lymph node metastases (68-Ga-PSMA-PET) in the salvage setting
- Prevalence of distant metastases (68-Ga-PSMA-PET/m-MRT) in the salvage setting
- Prevalence of local recurrent disease (68-Ga-PSMA-PET) in the salvage setting
- Time to hormone therapy/chemotherapy |
- PSA respons
- PSA respons (vid 3, 6, 9, 12, och24 månader efter avslutad behandling
- Totalöverlevnad
- Toxicitet
- Livskvalitet
- Prevalens av lymfkörtelmetastasering (utvärderat med 68-Ga-PSMA-PET)
- Prevalens av fjärrmetastasering ( utvärderat med 68-Ga-PSMA-PET/m-MRT)
- Prevalens lokalt återfall ( utvärderat med 68-Ga-PSMA-PET)
- Tid till start av hormonell behandling eller cytostatikabehandling
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Confirmed prostate cancer
- PSA recurrence after prostatectomy (defined as a PSA ˃ 0.2 ng/ml confirmed in a second sample)
- Expected Life-expectancy of ˃ 10 years
- Any pT, pN0/X, M0/X
- Patients suitable for radiotherapy |
- Konfirmerad prostatacancer
- Återfall i prostatacancer (definierat som en förhöjning av PSA med ˃ 0.2 ng/ml, konfirmerat med ett andra blodprov)
- Förväntad överlevnad ˃ 10 år
- Alla T, N0/X, M0/X
- Patient lämplig för att erhålla strålbehandling |
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E.4 | Principal exclusion criteria |
- Previous malignancy other than basalioma within the last 5 years
- Previous or ongoing hormonal therapy
- Inability to sign written informed concent |
- Tidigare malignitet förutom basaliom inom de senaste 5 åren
- Tidigare eller pågående hormonell behandling
- Inkapabel att signera informerat samtycke |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The ability of 68-Ga-PSMA-PET to identify prostate cancer recurrence in patients with biochemical relapse after prostatectomy. |
Att med hjälp av 68-Ga-PSMA-PET identifiera prostata cancer recidivlokaler hos patienter med återfall efter prostatektomi. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 5 weeks of radiotherapy. |
Efter 5 veckors strålbehandling. |
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E.5.2 | Secondary end point(s) |
- PSA response (during treatment)
- PSA response (at 3, 6, 9, 12, and 24 months post-treatment)
- Overall survival
- Toxicity
- Quality of Life
- Prevalence of lymph node metastases (68-Ga-PSMA-PET) in the salvage setting
- Prevalence of distant metastases (68-Ga-PSMA-PET) in the salvage setting
- Prevalence of local recurrent disease (68-Ga-PSMA-PET/m-MRT) in the salvage setting
- Time to hormone therapy/chemotherapy |
- PSA respons (under behandling)
- PSA respons (vid 3, 6, 9, 12 och 24 månader efter behandling)
- Totalöverlevnad
- Toxicitet
- Livskvalitet
- Förekomst av lymfkörtelmetastasering (68-Ga-PSMA-PET) under den understödjande behandlingen
- Förekomst av fjärrmetastaser (68-Ga-PSMA-PET) under den understödjande behandlingen
- Förekomst av lokalrecidiv (68-Ga-PSMA-PET/m-MRT under den understödjande behandlingen
- Tid till hormonell behandling/cytostatikabehandling
|
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- PSA evaluation weekly during radiotherapy
- Evaluation with 68-Ga-PSMA-PET after 5 weeks of radiotherapy
- PSA evaluation at 3, 6, 9, 12 months after end of radiotherapy, thereafter every 6 months until progressive disease.
- Evaluation of quality of life before start of treatment, at end of radiotherapy, and at 1 year after end of radiotherapy
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- Utvärdering av PSA 1 gång per vecka under strålbehandlingen
- Utvärdering med 68-Ga-PSMA efter 5 veckors strålbehandling
- Utvärdering av PSA vid 3, 6, 9 och 12 månader efter avslutad strålbehandling, därefter var sjätte månad fram till progressiv sjukdom
- Utvärdering av livskvalitet före start av behandling, vid avslut av behandling samt 1 år efter avslutad strålbehandling |
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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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |