Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Neoplasms
- Sponsor
- Tampere University Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Biopsy-proven prostate Cancer
- •One or two risk factors for intermediate prostate cancer:
- •Gleason score 7
- •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)
Outcomes
Primary Outcomes
To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy
Time Frame: 1 to 3 months
Prostate specific antigen (PSA) recurrence
Secondary Outcomes
- Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy(0 - 12 months)
- quality of life changes(1 to 3 months)