3D-Conformal Radiation vs Helical Tomotherapy in Prostate Cancer

NCT ID: NCT00326638

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2020-06-30

Brief Summary

In this study we are comparing two forms of radiotherapy. This study is being done because it is not clear at present time whether intensity modulated radiotherapy (IMRT) can reduce side effects of radiotherapy compared to standard radiotherapy (called 3D-Conformal Radiotherapy).

Detailed Description

Radical radiation therapy plays an important role in the management of prostate cancer, yielding comparable long-term outcomes to surgery. Unfortunately, long term disease free survival data using PSA criteria have shown that less than 50% of high-risk patients are free of disease at 10 years. To improve on the results of conventional dose radiotherapy dose escalation with three-dimensional conformal radiation has been employed. Due to the irregular shape of the prostate and the variable motion of this organ there is substantial radiation of adjacent normal surrounding tissue during treatment which results in radiation-induced toxicity. Intensity-modulated radiation therapy (IMRT) is a new form of radiation therapy. Preliminary evidence suggests that IMRT improves the dose distribution during radiation therapy of the prostate. The hypothesis of this study is that IMRT delivered using Helical Tomotherapy can reduce late toxicity of radical radiotherapy as compared to three-dimensional conformal radiation (3DCRT) in high-risk prostate cancer patients.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: 3D-Conformal Radiation

Intervention: Standard radiation treatment for high risk prostate cancer. Once daily Monday to Friday for 8 weeks.

3DCRT 7800 cGY/39 Fractions/ STD Technique*

• Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23
• Boost 6 F 3DCRT to Prostate 3,200 cGy/16

Group Type: OTHER

Arm A: 3D-Conformal Radiation

Intervention Type: OTHER

3DCRT 7800 cGY/39 Fractions/ STD Technique* once daily Monday to Friday for 8 weeks

• Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23
• Boost 6 F 3DCRT to Prostate 3,200 cGy/16

Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy

Intervention: Helical Tomotherapy Intensity Modulated Radiotherapy (IMRT) once daily Monday to Friday for 8 weeks.

IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions Boost IMRT to Prostate 3,200 cGy/16

Group Type: EXPERIMENTAL

Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy

Intervention Type: RADIATION

IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions once daily Monday to Friday for 8 weeks

• Initial IMRT to Nodes/Prostate + Seminal Vesicles 4,600 cGy/23
• Boost IMRT to Prostate 3,200 cGy/16

Interventions

Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy

IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions once daily Monday to Friday for 8 weeks

• Initial IMRT to Nodes/Prostate + Seminal Vesicles 4,600 cGy/23
• Boost IMRT to Prostate 3,200 cGy/16

Intervention Type: RADIATION

Arm A: 3D-Conformal Radiation

3DCRT 7800 cGY/39 Fractions/ STD Technique* once daily Monday to Friday for 8 weeks

• Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23
• Boost 6 F 3DCRT to Prostate 3,200 cGy/16

Intervention Type: OTHER

Other Intervention Names

IMRT; Radiation Therapy

Eligibility Criteria

Inclusion Criteria

1. A pathologic diagnosis of adenocarcinoma of the prostate

2. Age greater than 18 years

3. ECOG performance status of 2 or less.

4. Presence of any of the following high risk features:

• Clinical stage cT3-4 or
• Gleason score 8-10 or
• Pre-treatment PSA > 20ng/ml or
• Clinical N1/N2 or pathologic N1/N2

Exclusion Criteria

1. Patients with contraindication to radical radiation therapy including inflammatory bowel disease

2. Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer

3. Prior pelvic radiotherapy for other malignancies

4. Prior cytotoxic chemotherapy

5. Prior orchiectomy, radical prostatectomy, cryotherapy or thermal ablation therapy for prostate cancer

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shawn Malone, MD

Role: STUDY_DIRECTOR

Ottawa Hospital Research Institute

Locations

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

OTT 05-02

Identifier Type: -

Identifier Source: secondary_id

2005242-01H

Identifier Type: -

Identifier Source: org_study_id