Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate

NCT ID: NCT00915122

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2023-10-24

Brief Summary

The purpose of this study is to determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer. All eligible patients with high risk prostate cancer who are going to have primary radiation therapy to the pelvic lymph nodes and prostate seminal vesicles with or without concurrent hormonal therapy will be approached regarding study entry.

Detailed Description

Prostate cancer is now the most commonly diagnosed cancer in Canadian men and is the third most common cause of cancer death.1 Locally advanced prostate cancer (clinical T3/T4) is uncommon in North America because of earlier diagnosis following widespread PSA testing and patient information campaigns. However, in the past decade the term high-risk prostate cancer has been developed to include the previous locally advanced disease and patient with T1/T2 disease with poor prognostic features (either a high Prostate Specific Antigen or high Gleason score). The risk of involvement of pelvic lymph nodes by prostate cancer for certain subgroups of intermediate risk and most high risk prostate cancer may be substantial. The long term results of conventional dose (66-70 Gy) external beam radiation therapy for intermediate and locally advanced prostate cancer have been disappointing. The combination of hormonal therapy and radiation therapy or radiation therapy dose escalation are the two strategies which have been evaluated and are now used to improve these results.

Conditions

Adenocarcinoma of the Prostate

Keywords

IMRT treatment for Prostate cancer patients; Radiation treatment for prostate cancer; cancer of the prostate; Patients with high risk adenocarcinoma of the prostate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMRT in prostate cancer

Group Type: EXPERIMENTAL

Dose Escalated IMRT

Intervention Type: RADIATION

Patients will receive external beam RT 55.1Gy in 29 once daily fractions to pelvic lymph nodes/prostate/seminal vesicles followed by 24.7Gy in 13 once daily fractions to the prostate/seminal vesicles using intensity modulated radiation therapy.

Interventions

Dose Escalated IMRT

Patients will receive external beam RT 55.1Gy in 29 once daily fractions to pelvic lymph nodes/prostate/seminal vesicles followed by 24.7Gy in 13 once daily fractions to the prostate/seminal vesicles using intensity modulated radiation therapy.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• A histologic diagnosis of adenocarcinoma of the prostate within six months of entry.
• Clinical Stage T1-T2 with (PSA >20 or Gleason score >7)
• Clinical Stage T3, T4
• Bone scan reported as negative for metastases within 6 months of study entry.
• All patients must have a CT scan of the abdomen and pelvis reported as negative for nodal metastases within 12 wks of study entry.
• The patient must not have received greater than 6 months of hormonal therapy.
• The patient must not have received cytotoxic anticancer therapy prior to study entry.
• Patients must have an ECOG performance status of 2 or less.
• Age 80 years old or less
• Signed informed consent

Exclusion Criteria

• Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
• Patients with prior colorectal surgery
• Patients with prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer

• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tara Rosewell, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Princess Margaret Hospital

Locations

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Bayley A, Rosewall T, Craig T, Bristow R, Chung P, Gospodarowicz M, Menard C, Milosevic M, Warde P, Catton C. Clinical application of high-dose, image-guided intensity-modulated radiotherapy in high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):477-83. doi: 10.1016/j.ijrobp.2009.05.006. Epub 2009 Sep 3.

Reference Type: BACKGROUND

PMID: 19733014 (View on PubMed)

Other Identifiers

UHN REB 05-0396-C

Identifier Type: -

Identifier Source: org_study_id