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Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate

Primary Purpose

Adenocarcinoma of the Prostate

Status

Active

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Dose Escalated IMRT

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring IMRT treatment for Prostate cancer patients, Radiation treatment for prostate cancer, cancer of the prostate, Patients with high risk adenocarcinoma of the prostate

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University Health Network, Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT in prostate cancer

Arm Description

Outcomes

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.

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

Full Information

NCT ID

NCT00915122

First Posted

June 2, 2009

Last Updated

May 7, 2023

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT00915122

Brief Title

Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2005 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Prostate

Keywords

IMRT treatment for Prostate cancer patients, Radiation treatment for prostate cancer, cancer of the prostate, Patients with high risk adenocarcinoma of the prostate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IMRT in prostate cancer

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Dose Escalated IMRT

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tara Rosewell, MD

Organizational Affiliation

University Health Network, Princess Margaret Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Health Network, Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

19733014

Citation

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.

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