Prostate Neoplasms, Toxicity Due to Radiotherapy
Conditions
Keywords
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
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.
Interventions
RADIATIONFractionation
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.
RADIATIONhypofractionated
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
RADIATIONstereotactic fractionation
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
Sponsors
Tampere University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy | 1 to 3 months | Prostate specific antigen (PSA) recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy | 0 - 12 months | PSA recurrence |
| quality of life changes | 1 to 3 months | questionaires |
Countries
Finland
Outcome results
None listed