Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2014-05-31
2020-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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
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.
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
Interventions
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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.
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
30 Years
MALE
No
Sponsors
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Tampere University Hospital
OTHER
Responsible Party
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Principal Investigators
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Petri Reinikainen
Role: PRINCIPAL_INVESTIGATOR
Tampere Unviersity Hospital
Locations
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Tampere University Hospital
Tampere, , Finland
Countries
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References
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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 Jul;75:58-68. doi: 10.1016/j.ejmp.2020.06.010. Epub 2020 Jun 12.
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.
Other Identifiers
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R14009
Identifier Type: OTHER
Identifier Source: secondary_id
ETL R14009
Identifier Type: -
Identifier Source: org_study_id