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Prostate Cancer Stereotactic Radiotherapy (ESKO)

Primary Purpose

Prostate Neoplasms, Toxicity Due to Radiotherapy

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Fractionation
hypofractionated
stereotactic fractionation
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Neoplasms focused on measuring 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

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional fractionation

hypofractionated

Stereotactic fractionation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy
PSA recurrence
quality of life changes
questionaires

Full Information

First Posted
May 21, 2014
Last Updated
October 26, 2020
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02319239
Brief Title
Prostate Cancer Stereotactic Radiotherapy
Acronym
ESKO
Official Title
Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional fractionation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
hypofractionated
Arm Type
Experimental
Arm Description
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.
Arm Title
Stereotactic fractionation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Fractionation
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
hypofractionated
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
stereotactic fractionation
Intervention Description
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
Primary Outcome Measure Information:
Title
To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy
Description
Prostate specific antigen (PSA) recurrence
Time Frame
1 to 3 months
Secondary Outcome Measure Information:
Title
Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy
Description
PSA recurrence
Time Frame
0 - 12 months
Title
quality of life changes
Description
questionaires
Time Frame
1 to 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petri Reinikainen
Organizational Affiliation
Tampere Unviersity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35435111
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.
Results Reference
derived
PubMed Identifier
32540647
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.
Results Reference
derived
PubMed Identifier
30527084
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.
Results Reference
derived

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Prostate Cancer Stereotactic Radiotherapy

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