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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

Phase 1/Phase 2
80 Years
Open (Enrolling)
Adenocarcinoma of the Prostate

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Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

after all patients have completed study intervention

Safety Issue:


Principal Investigator

Andrew Bayley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital


Canada: Ethics Review Committee

Study ID:

UHN REB 05-0396-C



Start Date:

November 2005

Completion Date:

November 2014

Related Keywords:

  • Adenocarcinoma of the Prostate
  • IMRT treatment for Prostate cancer patients
  • Radiation treatment for prostate cancer
  • cancer of the prostate
  • Patients with high risk adenocarcinoma of the prostate
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms