Clinical trial · Interventional
Prostate Cancer Stereotactic Radiotherapy
Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Neoplasms | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Toxicity Due to Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fractionation | Radiation | — | UNRESOLVED |
| hypofractionated | Radiation | — | UNRESOLVED |
| stereotactic fractionation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Conventional fractionation
- description
- 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.
- interventionNames
- Radiation: Fractionation
- type
- EXPERIMENTAL
- label
- hypofractionated
- description
- 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.
- interventionNames
- Radiation: hypofractionated
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
Show eligibility criteria text
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)
References
Publications (3)
- DERIVEDVanhanen 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 35435111
- DERIVEDVanhanen 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 32540647
- DERIVEDVanhanen 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 30527084