Intensity Modulated Radiation Therapy - Prostate Cancer

NCT00188513 | Completed Phase 1

• 1 other identifier: UHN REB 01-0181-C
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

There are several different treatment schedules being used across the world for treatment of prostate cancer with radiation therapy. In order to determine the best radiation treatment for this disease, a study is being performed by the doctors at the Princess Margaret Hospital. This study will try to measure the effectiveness and side effects of an increased dose of radiation to the prostate that is also given over a shorter number of weeks than is usually done. In order to try to reduce the possible side effects of the radiation therapy the treatment will be given using special techniques to shield as much of your normal body tissues as possible. This method of treatment is called conformal intensity modulated radiation therapy, or IMRT.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• To determine feasibility and late toxicity of administering 66 Gy in 22 fractions over 4.5 weeks (using conformal IMRT treatment techniques) to the prostate and adjacent tissues in patients with localized prostate ca

  at each post treatment follow-up for up to 3 years

Secondary Outcomes (3)

• To evaluate acute toxicity of therapy

  weekly during RT

• To evaluate local control as assessed by prostate biopsy at 2.5 years

  2.5 years

• To evaluate time to disease progression

  5 years

Study Arms (1)

Conformal intensity modulated radiotherapy (IMRT)

EXPERIMENTAL

All patients shall receive a continuous course of intensity modulated conformal radiotherapy consisting of 66 Gy in 22 (3 Gy) fractions over 4.5 weeks.

Procedure: conformal intensity modulated radiotherapy (IMRT)

Interventions

conformal intensity modulated radiotherapy (IMRT) PROCEDURE

Conformal intensity modulated radiotherapy (IMRT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of adenocarcinoma of the prostate within six months of entry
• Clinical stage T1B, T1C, T2A-C NX MO (see Appendix 1 for staging). Any Gleason score is eligible for entry, but Gleason score must be determined.
• Patients with a PSA \>10.0 and Gleason score of 7; or patients with any PSA value and Gleason score of \>8 must have clinically negative lymph nodes as determined by a pelvic CT scan done within 12 weeks of entry. A negative bone scan is required before entry for all patients with Gleason score \>8, or any patient with a Gleason score of 7, and a PSA \>10.
• The patient must not have received any cytotoxic anticancer therapy. Previous or concurrent hormonal therapy for local disease is acceptable.
• ECOG performance status of 1 or less
• Age 80 years old or less
• Serum PSA \<25 ng/ml within 4 weeks of study entry
• Informed consent

You may not qualify if:

• Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
• Patients with prior colorectal surgery
• Any prior pelvic radiotherapy. Any prior TURP done \<12 weeks from study entry.
• Any previous cytotoxic chemotherapy
• Patients with prior malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Charles Catton, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2001
• Primary Completion: April 1, 2006
• Study Completion: April 4, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

CA (1)