Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer

Adenocarcinoma of the Prostate Clinical Trial

Official title:

Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02761889
• Other study ID #: HYPO
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2019
• Source: Fundacao Champalimaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study evaluates the clinical outcomes following definitive ultra-high dose per fraction external beam radiation therapy delivered in patients with organ-confined adenocarcinoma of the prostate.

Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility, while a urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. Previously untreated patients with prostate cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.

Patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months (+/- 6 weeks) thereafter. Acute and late toxicity evaluations will focus, though not exclusively, on urinary, rectal and sexual functions and will be assessed through validated Expanded Prostate Cancer Index Composite (EPIC), International prostate symptom score (IPSS) and International index of erectile function (IIEF) questionnaires. Serum Prostate Specific Antigen (PSA) values will be drawn on the same schedule as clinical follow-up. Patients will be continuously monitored for a minimum of 5 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Signed study specific informed consent form;

• Histologic confirmation of adenocarcinoma of the prostate by biopsy;

• Previous hormonal therapy is allowed (but not required);

• No direct evidence of regional or distant metastases after appropriate staging studies;

• Age = 40;

• Performance Status 0-2;

• American Urological Association (AUA) score must be = 20 (alpha blockers allowed);

• Computerized Tomography (CT) or Ultrasound-based volume estimation of prostate gland = 150 grams.

Exclusion Criteria:

• Metastatic disease from prostate cancer on imaging studies MRI evidence of radiographic T3, T4;

• Previous pelvic radiotherapy;

• Previous surgery for prostate cancer;

• Previous hormonal therapy given for more than 6 months prior to therapy;

• History of Crohn's Disease or Ulcerative Colitis;

• Previous significant obstructive symptoms;

• Significant psychiatric illness;

• Severe, active co-morbidity as defined in section 3.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms

Intervention

Radiation:
• IGRT 45 Gy in 5 fractions of 9 Gy
Previously untreated patients with prostate cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.

Procedure:
• Image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT)
Patients enrolled in the study will undergo IGRT-VMAT with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility.

Device:
• Rectal balloon with air filling
A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility.
• Urethral catheter loaded with beacon transponders
A urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking.

Locations

Country	Name	City	State
Portugal	Champalimaud Foundation	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Fundacao Champalimaud

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related grade 3 gastrointestinal or genitourinary toxicity adverse events as assessed by NCI v3.0.		5 years
Primary	Changes in PSA biochemical parameter measurements (Phoenix Definition).		5 years
Primary	Expanded Prostate Cancer Index Composite (EPIC) Questionnaire to measure quality of life.		5 years
Primary	International Index of Erectile Function (IIEF) Questionnaire to measure quality of life.		5 years
Primary	International Prostate Symptom Score (IPSS) Questionnaire to measure quality of life.		5 years