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NCT Number: NCT02319239

Prostate Cancer Stereotactic Radiotherapy

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.

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Key information

Conditions

Prostate Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Toxicity Due to Radiotherapy Urogenital Diseases Urogenital Neoplasms

Age range

30 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fractionation

Radiation

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.

hypofractionated

Radiation

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

stereotactic fractionation

Radiation

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 outcomes

  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

    Prostate specific antigen (PSA) recurrence

Secondary outcomes

  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 changes

    Time frame: 1 to 3 months

    questionaires

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.

Acronym: ESKO

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2014
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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