Prostate Cancer Stereotactic Radiotherapy
ESKO
Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.
2 other identifiers
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
December 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 28, 2020
October 1, 2020
6.4 years
May 21, 2014
October 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy
Prostate specific antigen (PSA) recurrence
1 to 3 months
Secondary Outcomes (2)
Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy
0 - 12 months
quality of life changes
1 to 3 months
Study Arms (3)
Conventional fractionation
ACTIVE COMPARATORDuring 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
EXPERIMENTALDuring 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
EXPERIMENTALDuring 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
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 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 5/5 fractions. DW-MRI at baseline, 3 months and 12 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tampere University Hospital
Tampere, 33521, Finland
Related Publications (3)
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.
PMID: 35435111DERIVEDVanhanen 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.
PMID: 32540647DERIVEDVanhanen 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.
PMID: 30527084DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petri Reinikainen
Tampere Unviersity Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2014
First Posted
December 18, 2014
Study Start
May 1, 2014
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
October 28, 2020
Record last verified: 2020-10