Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate

Adenocarcinoma of the Prostate Clinical Trial

Official title:

A Phase I/II Study of Dose Escalated Intensity Modulated Radiation Therapy (IMRT) for the Treatment of Pelvic Lymph Nodes and Primary Tumour in Patients With Carcinoma of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915122
• Other study ID #: UHN REB 05-0396-C
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2005
• Est. completion date: October 24, 2023

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 24, 2023
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		after all patients have completed study intervention
Secondary	acute toxicity of therapy;prostate motion when pelvic radiotherapy is delivered;treatment time required to deliver IMRT to the pelvic lymph nodes, prostate and seminal vesicles		after all patients have completed study intervention