Prostate Cancer Stereotactic Radiotherapy (ESKO)

Tampere University Hospital

Status: Completed

Conditions: Prostate Neoplasms; Toxicity Due to Radiotherapy

Treatments: Radiation: Fractionation; Radiation: hypofractionated; Radiation: stereotactic fractionation

Study type: Interventional

Funder types: Other

Identifiers

NCT02319239

R14009 (Other Identifier)

ETL R14009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 30+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Conventional fractionation

Active Comparator group

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.

Treatment:

Radiation: Fractionation

hypofractionated

Experimental group

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.

Treatment:

Radiation: hypofractionated

Stereotactic fractionation

Experimental group

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.

Treatment:

Radiation: stereotactic fractionation