Prostate Cancer Stereotactic Radiotherapy

Not Applicable

Completed

• Conditions: Prostate Neoplasms; Toxicity Due to Radiotherapy
• Interventions: Radiation: stereotactic fractionation; Radiation: hypofractionated; Radiation: Fractionation

• Registration Number: NCT02319239
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-18
• Status Verified: 2020-10
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stereotactic fractionation	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.
hypofractionated	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.
Conventional fractionation	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.

Primary Outcome Measures

Name	Time	Method
To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy	1 to 3 months	Prostate specific antigen (PSA) recurrence

Secondary Outcome Measures

Name	Time	Method
Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy	0 - 12 months	PSA recurrence
quality of life changes	1 to 3 months	questionaires

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland