Prostate Cancer Stereotactic Radiotherapy (ESKO)
Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.
Primary purpose of the study is to develop a stereotactic radiation treatment (RT) to prostate cancer which minimizes treatment related toxicity. Movement of the prostate during a radiation therapy will be monitored by temporary implanted electromagnetic transmitter. This data will be used to define prostate marginals (PTV) for stereotactic treatment. Radiation toxicity to rectum will be reduced by using a rectum fixation during a treatment.
Study group I (20 patients) will be treated 39 x 2 Gy and study group II (20 patients) with 20 x 3 Gy fractionation schedules. With the data collected from these groups treatment marginals to prostate will be defined and used to treat group III (40 patients) with 5 x 7.25 Gy.
Second purpose of this study is to assess if Diffusion-weighted magnetic resonance imaging could be used to evaluate radiation treatment response in intermediate prostate cancer. Androgen deprivation therapy is not allowed in this study.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
New local prostate cancer patients needing external radiotherapy are included into three radiation dose groups;
Group I will be treated normal dosing (39 x 2 Gy) and study group II with hypofractionated dosing (20 x 3 Gy) and group III extreme hypofractionated dosing. Primary goal is to develop safe and effective curative radiotherapy for these patients
Second aim is to study Diffusion-weighted magnetic resonance image (DW MRI) in radiation treatment response in intermediate prostate cancer.
Patients are followed by MRI, PSA, bone scans and quality of life questionaries.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Tampere, Finland, 33521
- Tampere University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Biopsy-proven prostate Cancer
One or two risk factors for intermediate prostate cancer:
- Gleason score 7
- T2b-T2c
- PSA 10-20 microg/l
- No need for androgen deprivation therapy
- Eligible fo MRI
- Radical radiotherapy
Exclusion Criteria:
- Locally advanced or metastatic prostate cancer
- Previous radiotherapy to pelvic reason
- Other severe disease
- Previous cancer within 5 years
- Severe urinary symptoms at the start of the study (over 20)
- Wide cavity after transurethral resection of prostate (TURP)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Conventional fractionation
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 15/39 fractions.
DW-MRI at baseline, 3 months and 12 months.
|
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 15/39 fractions.
DW-MRI at baseline, 3 months and 12 months.
|
|
Eksperimentel: hypofractionated
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 10/20 fractions.
DW-MRI at baseline, 3 months and 12 months.
|
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 10/20 fractions.
DW-MRI at baseline, 3 months and 12 months
|
|
Eksperimentel: Stereotactic fractionation
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 5/5 fractions.
DW-MRI at baseline, 3 months and 12 months.
|
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 5/5 fractions.
DW-MRI at baseline, 3 months and 12 months
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy
Tidsramme: 1 to 3 months
|
Prostate specific antigen (PSA) recurrence
|
1 to 3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy
Tidsramme: 0 - 12 months
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PSA recurrence
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0 - 12 months
|
|
quality of life changes
Tidsramme: 1 to 3 months
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questionaires
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1 to 3 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Petri Reinikainen, Tampere Unviersity Hospital
Publikationer og nyttige links
Generelle publikationer
- Vanhanen A, Reinikainen P, Kapanen M. Radiation-induced prostate swelling during SBRT of the prostate. Acta Oncol. 2022 Jun;61(6):698-704. doi: 10.1080/0284186X.2022.2062682. Epub 2022 Apr 17.
- Vanhanen A, Poulsen P, Kapanen M. Dosimetric effect of intrafraction motion and different localization strategies in prostate SBRT. Phys Med. 2020 Jun 12;75:58-68. doi: 10.1016/j.ejmp.2020.06.010. Online ahead of print.
- Vanhanen A, Syren H, Kapanen M. Localization accuracy of two electromagnetic tracking systems in prostate cancer radiotherapy: A comparison with fiducial marker based kilovoltage imaging. Phys Med. 2018 Dec;56:10-18. doi: 10.1016/j.ejmp.2018.11.007. Epub 2018 Nov 16.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ETL R14009
- R14009 (Anden identifikator: TampereUH)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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