Intraprostatic MAXimal Simultaneous Boost

NCT00798837 | Terminated DMC

• 1 other identifier: IMAX
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This trial uses a type of radiotherapy called intensity modulated radiotherapy (IMRT), which is able to deliver the radiation to the prostate while delivering less dose to the surrounding normal organs compared with standard 3D conformal radiotherapy presently used at the BCCA. This trial will use RapidArc IMRT, which is a new way of delivering IMRT, where the radiation dose is delivered in a single rotation of the radiotherapy machine around the patient. This new method of delivering IMRT has been shown to be at least as good as conventional IMRT at delivering the dose, and takes less time to do so. The aim of this study is to deliver a higher radiation dose to the prostate gland than the standard treatment while not increasing dose to the normal organs. In this way, it is hoped that the likelihood of the cancer coming back will be reduced without causing an increase in side-effects.

Conditions

Prostate Cancer

Keywords

prostate; cancer; IMRT; radiation

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 2-4 gastrointestinal and genitourinary toxicity

  No time frame (post-treatment)

Secondary Outcomes (5)

• Quality of life (EPIC, IPSS and SHIM questionnaires)

  Post-treatment; every 6 mos until 5 years - then annual

• Percentage of CTV treated to boost dose

  Immediately post-treatment

• Time-cost analysis compared to external-beam radiotherapy with brachytherapy boost

  No time frame

• Accuracy of surrogate urethra compared to T2-MRI localization

  No time frame

• Quantification of dose received by lesions identified by diffusion-weighted and dynamic contrast enhanced MRI

  No time frame

Study Arms (1)

IMAX

OTHER

There is only one arm in this study. Each patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) using RapidArc for optimization and delivery. Doses of radiotherapy are as follows: * The prescription dose will be 73.7 Gy in 28 fractions. * A simultaneous intraprostatic maximal simultaneous boost will be given to as much of the CTV as possible without contravening OAR dose constraints.

Radiation: Intraprostatic maximal simultaneous boost

Interventions

Intraprostatic maximal simultaneous boost RADIATION

Each patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) using RapidArc for optimization and delivery. Doses of radiotherapy are as follows: * The prescription dose will be 73.7 Gy in 28 fractions * A simultaneous intraprostatic boost will be given to as much of the CTV as possible without contravening OAR dose constraints.

IMAX

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically proven adenocarcinoma of the prostate.
• Registration must occur within 26 weeks of biopsy.
• History and physical examination (including digital rectal examination (DRE)) within 8 weeks prior to registration.
• Patients must have intermediate risk prostate cancer, as defined by:
• PSA ≤ 20 ng/ml,
• Gleason ≤ 7,
• Stage ≤ T2c, and
• Do not meet criteria for low-risk prostate cancer (Low-risk = All of: PSA ≤ 10 + Gleason ≤ 6 + stage ≤ T2b)
• Patients must have the following blood tests within two weeks of registration:
• Prostate specific antigen (PSA), testosterone (TTT), complete blood count (CBC), electrolytes, creatinine.
• Patients with values for one or more of these tests (not including PSA) that fall outside the normal range will need to be reviewed by the oncologist to determine their eligibility for this study.
• Patients must have an estimated life expectancy of at least 10 years.
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
• Patients must have no contraindications to high dose pelvic irradiation.
• Patients must not have received prior radiation therapy to the pelvis.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• William J Morris, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. James Morris

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 26, 2008
• Study Start: December 1, 2008
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

CA (1)