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


Phase 1
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


Inclusion Criteria:



1. Patients must have histologically proven adenocarcinoma of the prostate.

2. Registration must occur within 26 weeks of biopsy.

3. History and physical examination (including digital rectal examination (DRE)) within
8 weeks prior to registration.

4. 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)

5. 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.

6. Patients must have an estimated life expectancy of at least 10 years.

7. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0 - 2.

8. Patients must have no contraindications to high dose pelvic irradiation.

9. Patients must not have received prior radiation therapy to the pelvis.

10. Patients must have no history of inflammatory bowel disease.

11. Patients must not have received prior hormonal therapy or chemotherapy.

12. Patients must not have any hormonal therapy planned as part of the therapeutic
intervention.

13. Patients must have no contraindication to MRI scanning.

14. Patients should not have an artificial hip

15. 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of grade 2-4 gastrointestinal and genitourinary toxicity

Outcome Time Frame:

No time frame (post-treatment)

Safety Issue:

Yes

Principal Investigator

William J Morris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Canada: Health Canada

Study ID:

IMAX

NCT ID:

NCT00798837

Start Date:

December 2008

Completion Date:

October 2016

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • IMRT
  • radiation
  • Prostatic Neoplasms

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