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Prostate Cancer Stereotactic Radiotherapy

NCT02319239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-10-28

No results posted yet for this study

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.

Conditions

  • Prostate Neoplasms
  • Toxicity Due to Radiotherapy

Interventions

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.

RADIATION

hypofractionated

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

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

Sponsors & Collaborators

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Petri Reinikainen · Tampere Unviersity Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02319239 on ClinicalTrials.gov