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NCT Number: NCT00230438

External Beam Radiation Therapy - Target Volume

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External beam radiotherapy

Procedure

Primary outcomes

  1. To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy

    Time frame: After data acquisition

Secondary outcomes

  1. To compare the reproducibility of clinical target volume and rectal wall volume delineation on MRI and CT.

    Time frame: After data acquisition

  2. To compare the location of the urethral anastomosis defined on MRI as compared to a fiducial marker placed under TRUS-guidance adjacent to the anastomosis.

    Time frame: After data acquisition

  3. To measure the amount of intrafraction movement and deformity of the prostatic bed and seminal vesicles with current bowel regimen of daily milk of magnesia using cinematic MRI.

    Time frame: After data acquisition

  4. To determine the optimal radiation technique that encompasses the MRI-defined PTV whilst respecting bowel and bladder dose constraints.

    Time frame: After data acquisition

  5. To measure the amount of interfraction movement and deformity of the bladder, rectum, and surgical clips within the operative bed using daily cone-beam CT imaging.

    Time frame: After data acquisition

  6. To explore the utility of IV contrast for the delineation of gross tumor recurrence and normal blood vessels.

    Time frame: After data acquisition

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

A Pilot Study to Develop a Technique for External Beam Radiotherapy After Radical Prostatectomy Based on MRI-Delineation of the Clinical Target Volume

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Sep 30, 2005
Registry last updated
Jan 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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