Clinical trial NCT02319239: Prostate Cancer Stereotactic Radiotherapy
Official title: Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Neoplasms
Toxicity Due to Radiotherapy
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
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 80
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy
timeFrame: 1 to 3 months
Secondary outcomes:
measure: Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy
timeFrame: 0 - 12 months
measure: quality of life changes
timeFrame: 1 to 3 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere Unviersity Hospital
name: Petri Reinikainen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Vanhanen A, Poulsen P, Kapanen M. Dosimetric effect of intrafraction motion and different localization strategies in prostate SBRT. Phys Med. 2020 Jun 12;75:58-68. doi: 10.1016/j.ejmp.2020.06.010. Online ahead of print.
citation: 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.