NCT01028885

Brief Summary

This is a prospective clinical trial examining the use of MRI to measure internal organ motion and any resulting changes in the target volume (shape and location) during a course of post-operative radiation therapy for prostate cancer. The goal is to better understand and characterize these physiologic variations so that they can be accounted for during the treatment planning process. The ultimate longer-term clinical goal here is to provide a form of adaptive radiation therapy in the future, such that if major changes are seen over an 8-week course of radiation therapy in our study. This may argue for hypofractionating those patients who are most likely to have major shifts over time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

2.7 years

First QC Date

December 7, 2009

Last Update Submit

July 24, 2019

Conditions

Prostate CancerAdenocarcinoma of the ProstateStage I Prostate CancerStage II Prostate CancerStage III Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Clinical treatment target motion and deformation as quantified by co-registration of weekly MRI scans with original treatment planning MRI scans

  • Avoidance of any unexpected grade 3 or 4 toxicities

Secondary Outcomes (5)

  • Comparison of MRI and CT delineated target volumes defined during the treatment planning process

  • Distributions of clinical target volume (CTV), bladder and rectum volumes, and percent change from baseline

  • Incidence of CTV falling outside the planned treatment volume (PTV)

  • Distributions of the proportion of the total CTV which falls outside the PTV

  • Dose-volume exposures

Study Arms (1)

Arm I

EXPERIMENTAL

Patients undergo MRI and CT scan-based simulation for treatment planning with endorectal balloon target immobilization. The treatment target volumes and surrounding organs at risk are contoured, treatment plan developed and approved. Patients then undergo 39 fractions of image-guided intensity-modulated radiotherapy over 8 weeks. Patients also undergo weekly MRI scans of the pelvis (in the planned treatment position) during radiotherapy.

Procedure: radiation therapy treatment planning/simulationProcedure: intensity-modulated radiation therapyProcedure: image-guided radiation therapyProcedure: magnetic resonance imagingProcedure: computed tomography

Interventions

radiation therapy treatment planning/simulationPROCEDURE
Arm I
intensity-modulated radiation therapyPROCEDURE
Also known as: IMRT
Arm I
image-guided radiation therapyPROCEDURE
Arm I
magnetic resonance imagingPROCEDURE
Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Arm I
computed tomographyPROCEDURE
Also known as: tomography, computed
Arm I

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completion of a radical prostatectomy for adenocarcinoma of the prostate
  • Scheduled post-operative radiation therapy as part of the patient's treatment for prostate cancer
  • Subjects are capable of giving informed consent

You may not qualify if:

  • The presence of grossly visualized or palpable disease recurrence
  • Patients who are unable to undergo an MRI scan such as those with an implanted permanent pacemaker or ICD
  • Patients with metastatic disease or an increasing PSA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Intensity-ModulatedRadiotherapy, Image-GuidedMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeuticsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Neha Vapiwala

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2012

Study Completion

June 1, 2018

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

US(1)