External Beam Radiation Therapy - Target Volume

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Procedure: External Beam Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00230438

UHN REB 04-0759-CE

Details and patient eligibility

About

Delivery of conformal radiation therapy following radical prostatectomy is limited by the inability to define the clinical target volume (CTV). This stems from a poor understanding of patterns of local recurrence and limitations of standard imaging techniques.Magnetic Resonance Imaging (MRI) is a promising modality for imaging the prostatic bed following radical prostatectomy. MRI provides more detailed postoperative anatomy to guide CTV delineation, the ability to document local recurrence patterns, and a method to assess intrafraction prostatic bed motion and deformity to define appropriate planning target volume margins. The aim of this pilot study is to develop a technique for external beam radiation therapy (EBRT) following radical prostatectomy based on MRI-delineation of the CTV. Twenty patients will be enrolled in this pilot, development phase.

Enrollment: 27 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients following radical prostatectomy for prostate adenocarcinoma with one or more of the following adverse features:

pT2 + positive surgical margins ) pT3 ) PSA ≤ 2ng/ml Persistently elevated PSA at 3 months )

• Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse
• Patients being planned for radiation therapy
• No evidence of distant metastases
• Age ≥ 18 years
• ECOG performance status 0 or 1
• Informed consent

Exclusion criteria

• Contraindications to MRI Patients weighing >136 kgs (weight limit for the scanner tables) Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI.
• Severe claustrophobia
• Inflammatory bowel disease or collagen vascular disease
• Previous colorectal surgery
• Previous pelvic radiotherapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

External Beam Radiation Therapy

Experimental group

Treatment:

Procedure: External Beam Radiotherapy