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External Beam Radiation Therapy - Target Volume

University Health Network, Toronto logo

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)

27 participants in 1 patient group

External Beam Radiation Therapy
Experimental group
Treatment:
Procedure: External Beam Radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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