Status:
COMPLETED
Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate
Lead Sponsor:
University Health Network, Toronto
Conditions:
Adenocarcinoma of the Prostate
Eligibility:
MALE
Up to 80 years
Phase:
PHASE1
PHASE2
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 ris...
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 Am...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2023
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00915122
Start Date
November 1 2005
End Date
October 24 2023
Last Update
December 6 2023
Active Locations (1)
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1
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9