Intensity Modulated Radiation Therapy - Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188513
• Other study ID #: UHN REB 01-0181-C
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2001
• Est. completion date: April 4, 2017

Study information

• Verified date: June 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: April 4, 2017
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Procedure:
• conformal intensity modulated radiotherapy (IMRT)

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate acute toxicity of therapy		weekly during RT
Secondary	To evaluate local control as assessed by prostate biopsy at 2.5 years		2.5 years
Secondary	To evaluate time to disease progression		5 years