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Intraprostatic MAXimal Simultaneous Boost

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Intraprostatic maximal simultaneous boost

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate, cancer, IMRT, radiation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.
Patients must have no history of inflammatory bowel disease.
Patients must not have received prior hormonal therapy or chemotherapy.
Patients must not have any hormonal therapy planned as part of the therapeutic intervention.
Patients must have no contraindication to MRI scanning.
Patients should not have an artificial hip
Patients should not have a body mass index (BMI) of > 32. Note: BMI = weight in kg ÷ (height in metres)2

Exclusion Criteria:

1. Subjects that do not meet inclusion criteria.

Sites / Locations

British Columbia Cancer Agency - Vancouver Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IMAX

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of grade 2-4 gastrointestinal and genitourinary toxicity

Secondary Outcome Measures

Quality of life (EPIC, IPSS and SHIM questionnaires)

Percentage of CTV treated to boost dose

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

Accuracy of surrogate urethra compared to T2-MRI localization

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

Full Information

NCT ID

NCT00798837

First Posted

November 24, 2008

Last Updated

July 9, 2018

Sponsor

British Columbia Cancer Agency

1. Study Identification

Unique Protocol Identification Number

NCT00798837

Brief Title

Intraprostatic MAXimal Simultaneous Boost

Official Title

A Dose-escalation Study Using a Maximal Simultaneous Intraprostatic Boost With RapidArc Intensity Modulated Radiotherapy in Intermediate Risk Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

Excess risk in rectal bleeding of first 10 patients

Study Start Date

December 2008 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

British Columbia Cancer Agency

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate, cancer, IMRT, radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IMAX

Arm Type

Other

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Intraprostatic maximal simultaneous boost

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of grade 2-4 gastrointestinal and genitourinary toxicity

Time Frame

No time frame (post-treatment)

Secondary Outcome Measure Information:

Title

Quality of life (EPIC, IPSS and SHIM questionnaires)

Time Frame

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

Title

Percentage of CTV treated to boost dose

Time Frame

Immediately post-treatment

Title

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

Time Frame

No time frame

Title

Accuracy of surrogate urethra compared to T2-MRI localization

Time Frame

No time frame

Title

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

Time Frame

No time frame

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Patients must have no history of inflammatory bowel disease. Patients must not have received prior hormonal therapy or chemotherapy. Patients must not have any hormonal therapy planned as part of the therapeutic intervention. Patients must have no contraindication to MRI scanning. Patients should not have an artificial hip Patients should not have a body mass index (BMI) of > 32. Note: BMI = weight in kg ÷ (height in metres)2 Exclusion Criteria: 1. Subjects that do not meet inclusion criteria.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William J Morris, MD

Organizational Affiliation

British Columbia Cancer Agency

Official's Role

Principal Investigator

Facility Information:

Facility Name

British Columbia Cancer Agency - Vancouver Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

12. IPD Sharing Statement

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