Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate
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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 |
- 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 ]
- 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 |
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| Canada, Ontario | |
| University Health Network, Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| 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: | December 17, 2012 |
| 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 Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013