Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00915122
First received: June 2, 2009
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of the Prostate
Radiation: Dose Escalated IMRT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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. [ Time Frame: after all patients have completed study intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: after all patients have completed study intervention ] [ Designated as safety issue: Yes ]

Enrollment: 81
Study Start Date: November 2005
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT in prostate cancer 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.

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915122

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Andrew Bayley, MD University Health Network, Princess Margaret Hospital
  More Information

Publications:
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00915122     History of Changes
Other Study ID Numbers: UHN REB 05-0396-C
Study First Received: June 2, 2009
Last Updated: June 11, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
IMRT treatment for Prostate cancer patients
Radiation treatment for prostate cancer
cancer of the prostate
Patients with high risk adenocarcinoma of the prostate

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014