3D-Conformal Radiation vs Helical Tomotherapy in Prostate Cancer

Ottawa Hospital Research Institute

Status: Unknown

Conditions: Prostate Cancer

Treatments: Radiation: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy; Other: Arm A: 3D-Conformal Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00326638

2005242-01H

OTT 05-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 72 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Arm A: 3D-Conformal Radiation

Other group

Description:

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

Treatment:

Other: Arm A: 3D-Conformal Radiation

Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy