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| ID | Type | Description | Link |
|---|---|---|---|
| R14009 | Other Identifier | TampereUH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional fractionation | Active Comparator | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionation | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy | PSA recurrence | 0 - 12 months |
| quality of life changes | questionaires |
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Inclusion Criteria:
Biopsy-proven prostate Cancer
One or two risk factors for intermediate prostate cancer:
No need for androgen deprivation therapy
Eligible fo MRI
Radical radiotherapy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petri Reinikainen | Tampere Unviersity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | 33521 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35435111 | Derived | 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. | |
| 32540647 | Derived | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D005834 | Genital Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D005591 | Chemical Fractionation |
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
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| hypofractionated | Radiation | 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 | Radiation | 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 |
|
| 1 to 3 months |
| 30527084 | Derived | 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. |
| D000091642 |
| Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |