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

NCT ID: NCT02761889

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-01
• Study Completion Date: 2022-09-30

Brief 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.

Conditions

Adenocarcinoma of the Prostate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IGRT 45 Gy in 5 fractions of 9 Gy

Patients will be treated using volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. Patients will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.

Group Type: EXPERIMENTAL

IGRT 45 Gy in 5 fractions of 9 Gy

Intervention Type: RADIATION

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

Image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT)

Intervention Type: PROCEDURE

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.

Rectal balloon with air filling

Intervention Type: DEVICE

A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility.

Urethral catheter loaded with beacon transponders

Intervention Type: DEVICE

A urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking.

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: PROCEDURE

Rectal balloon with air filling

A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fundacao Champalimaud

OTHER

Sponsor Role: lead

Responsible Party

Carlo Greco, MD

Director of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Greco, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacao Champalimaud

Locations

Champalimaud Foundation

Lisbon, , Portugal

Countries

Portugal

References

Greco C, Pares O, Pimentel N, Louro V, Nunes B, Kociolek J, Marques J, Fuks Z. Early PSA density kinetics predicts biochemical and local failure following extreme hypofractionated radiotherapy in intermediate-risk prostate cancer. Radiother Oncol. 2022 Apr;169:35-42. doi: 10.1016/j.radonc.2022.02.016. Epub 2022 Feb 18.

Reference Type: DERIVED

PMID: 35189157 (View on PubMed)

Other Identifiers

HYPO

Identifier Type: -

Identifier Source: org_study_id