Prostate Cancer Stereotactic Radiotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.

Conditions
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Prostate Neoplasms, Toxicity Due to Radiotherapy

Intervention / Treatment
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* Radiation: Fractionation
* Radiation: hypofractionated
* Radiation: stereotactic fractionation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional fractionation<br>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. | Radiation: Fractionation<br>* 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.<br>|
| Experimental: hypofractionated<br>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. | Radiation: hypofractionated<br>* 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<br>|
| Experimental: Stereotactic fractionation<br>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. | Radiation: stereotactic fractionation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1 to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate neoplasms, Urogenital neoplasms, Genital neoplasms, male, Radiation therapy, Prostate specific antigen, DW-MRI, diffusion weighted MRI, Intra-fractional movement, Hypofractionated radiotherapy, Stereotactic, Toxicity due to radiotherapy, Quality of life