Prostate Cancer
Conditions
Brief summary
The purpose of this research is to gather information on the safety and effectiveness of using an imaging technique called magnetic resonance imaging (MRI) to decrease radiation dose to the uninvolved prostate (areas of the prostate that do not clearly have cancer cells) while increasing radiation dose to the nodules (hardened areas of the prostate that have cancer cells).
Interventions
RADIATIONRadiation
Radiation to the prostate gland will be given daily (Mon-Friday) for 4 weeks.
RADIATIONMRI
The study doctor will use an MRI scan to take pictures of the prostate gland. These images of the prostate gland will let the study doctor know which areas of the prostate contain cancer cells that need to be targeted with higher doses of radiation and which uninvolved areas to target with lower doses of radiation.
OTHERAndrogen Deprivation Therapy
Treatment of treating physician choice will be given for 6-24 months.
Sponsors
University of Chicago
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
* Adult (≥ 18 years old) male patients with an ECOG Performance Status 0-2 * Histologically-confirmed, MRI-visible prostate adenocarcinoma with NCCN intermediate- or high-risk disease1 without extra-pelvic metastasis.
Exclusion criteria
* Distant metastases * Prior active treatment for prostate cancer including radical prostatectomy, high-intensity focused ultrasound (HIFU), cryosurgery, ADT, or cytotoxic chemotherapy for treatment of prostate cancer. Patients with prostate cancer on active surveillance prior to the study are not excluded if they have not received active treatment. * Prior pelvic radiotherapy including brachytherapy. * Additional active concurrent malignancies (except localized cutaneous squamous or basal cell carcinomas). * Comorbid conditions that, in the opinion of the treating radiation oncologist, preclude the patient from safely receiving the protocol-specified treatment including RT and/or ADT. * Patients with contraindications to MRI including patients with ferromagnetic materials in their body (e.g. bioimplants, surgical hardware, shrapnel), patients who are unable to receive contrast due to history of allergy or impaired renal function (glomerular filtration rate \< 30 mil/min), and patients unable to tolerate MRI for other reasons (e.g. significant claustrophobia). * Patients for whom hydrogel or hyaluronic acid spacer will be placed. * Patients incapable of giving informed consent. * Patients who are unable to adhere to the experimental protocols for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in bowel related quality of life | 12 months after treatment | Decrease by at least 5 points in bowel related endpoints as measured by Expanded Prostate Cancer Index Composite 26 (EPIC-26) questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical control | 2 year after start of treatment | Number of participants that have failed ADT therapy after 2 years as shown by prostate specific antigen (PSA) levels.. |
| Relationship between Imaging findings and Pathologic (tissue) findings | 12 months post treatment | Correlation between signs of cancer as seen by imaging and tissue (pathology) |
| Treatment Side effects | 12 months post treatment | Number of gastrointestinal, genitourinary, and sexual side effects that are grade 2 or above per the Common Terminology Criteria for Adverse Events (CTCAE) |
| Patient reported quality of life | 12 months post treatment | Improvement in patient reported quality of life (shown higher scores of worse symptoms) with the scale values assigned to each question ranging from 0 (best) to 4 (worst) of gastrointestinal, genitourinary, and sexual function as assess by Expanded Prostate Cancer Index (EPIC) questionnaires |
Countries
United States
Contacts
CONTACTClinical Trials Intake
PRINCIPAL_INVESTIGATORStanley Liauw
University of Chicago
Outcome results
None listed