Prostate Cancer Stereotactic Radiotherapy

Prostate Neoplasms Clinical Trial

— ESKO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319239
• Other study ID #: ETL R14009
• Secondary ID: R14009
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: October 2020

Study information

• Verified date: October 2020
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neoplasms
• Prostate Neoplasms
• Prostatic Neoplasms
• Toxicity Due to Radiotherapy

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy	Prostate specific antigen (PSA) recurrence	1 to 3 months
Secondary	Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy	PSA recurrence	0 - 12 months
Secondary	quality of life changes	questionaires	1 to 3 months