Know Cancer

or
forgot password

A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device


Phase 2
31 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device


- MRI using an endorectal coil done prior to treatment for staging.

- Baseline Quality of Life (QOL) assessment will be completed prior to treatment.

- Total androgen suppression is initiated and will continue for at least 6 months.

- Prostate Immobilization Device (PID) placed during the planning session.

- PID will be placed daily for the first 15 3D external beam radiation treatments.

- QOL assessment and follow-up will take place every 6 months for 3 years.


Inclusion Criteria:



- Biopsy proven prostate cancer

- Clinical Stage T1 - T4

- Negative bone scan

- PSA and routine blood work

- >30 years of age

- ECOG Performance 0,1, or 2

- No prior pelvic radiation

- No pacemaker

Exclusion Criteria:

- Inflammatory bowel disease (Crohns, or Ulcerative Colitis)

- Prostatic rectal fistula

- Stricture of anal canal

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rectal toxicity at six month intervals

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Anthony V. D'Amico, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

01-050

NCT ID:

NCT00114985

Start Date:

April 2001

Completion Date:

October 2008

Related Keywords:

  • Prostate Cancer
  • Total Androgen Suppression
  • Simulation
  • 3-D Conformal External Beam Radiation Therapy
  • Intra-rectal immobilization device
  • Quality of Life Assessment Questionnaire
  • Rectal Bleeding
  • Late effects
  • Prostatic Neoplasms

Name

Location