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Prostate Cancer Stereotactic Radiotherapy (ESKO)

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ClinicalTrials.gov Identifier: NCT02319239
Recruitment Status : Recruiting
First Posted : December 18, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Brief Summary:

Primary purpose of the study is to develop a stereotactic radiation treatment 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.


Condition or disease Intervention/treatment Phase
Prostate Neoplasms Toxicity Due to Radiotherapy Radiation: Fractionation Radiation: hypofractionation Radiation: stereotactic fractionation Not Applicable

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 hypofractionationated dosing. Primary goal is to develop safe and effective curative radiotherapy for these patients

Second aim is to study Diffusion-weighted magnetic resonance image in radiation treatment response in intermediate prostate cancer.

Patients are followed by MRI, PSA, bone scans and quality of life questionaries.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.
Study Start Date : May 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Conventional fractionation
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
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.
Experimental: hypofractionation
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: hypofractionation
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
Experimental: Stereotactic 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.
Radiation: stereotactic 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



Primary Outcome Measures :
  1. 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 ]
    PSA recurrence


Secondary Outcome Measures :
  1. Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy [ Time Frame: 0 - 12 months ]
    PSA recurrence

  2. quality of life [ Time Frame: 1 to 3 months ]
    quality of life questionaires



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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 RT to pelvic reason
  • Other severe disease
  • Previous cancer within 5 years
  • Severe urinary symptoms at the start of the study (I-PSS over 20)
  • Wide cavity after TURP

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319239


Contacts
Contact: Pirkko-Liisa Kellokumpu-Lehtinen, MD,PhD +358331163227 pirkko-liisa.kellokumpu-lehtinen@pshp.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Pirkko-Liisa Kellokumpu-Lehtinen       klpike@uta.fi   
Sub-Investigator: Petri Reinikainen, MD         
Sponsors and Collaborators
Tampere University Hospital
Investigators
Principal Investigator: Petri Reinikainen Tampere Unviersity Hospital

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02319239     History of Changes
Other Study ID Numbers: ETL R14009
R14009 ( Other Identifier: TampereUH )
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

Keywords provided by Tampere University Hospital:
Prostate neoplasms
Urogenital neoplasms
Genital neoplasms, male
Radiation therapy
Hypofractionated radiotherapy
Toxicity due to radiotherapy
PSA
DW-MRI, diffusion weighted MRI
Intra-fractional movement
Stereotactic
Quality of life

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases