Prostate Cancer, Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer
Conditions
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.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the use of MRI in delineating clinical target volumes, as well as endorectal balloon target immobilization in patients treated with radiation following radical prostatectomy. SECONDARY OBJECTIVES: II. Trends over time in CTV, bladder and rectum volumes and percent change from baseline at each time point. III. Frequency of events in which the CTV falls outside the PTV. IV. Proportion of the total CTV which falls outside the PTV at each event. V. Trends over time in dose-volume exposures for bladder and rectum. OUTLINE: 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.
Interventions
PROCEDUREintensity-modulated radiation therapy
PROCEDUREimage-guided radiation therapy
PROCEDUREmagnetic resonance imaging
PROCEDUREcomputed tomography
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion * 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 Exclusion * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Incidence of CTV falling outside the planned treatment volume (PTV) | — |
| Comparison of MRI and CT delineated target volumes defined during the treatment planning process | — |
| Dose-volume exposures | — |
| Distributions of the proportion of the total CTV which falls outside the PTV | — |
| Distributions of clinical target volume (CTV), bladder and rectum volumes, and percent change from baseline | — |
Countries
United States
Outcome results
None listed