Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
1. The investigators hypothesize that increasing radiation dose to the functional
MRI-defined lesion in the prostate bed will result in an improved initial complete
response (reduction in prostate-specific antigen (PSA) to < 0.1 ng/mL), which is related
to long-term outcome biochemically.
2. Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor
regions (when applicable).
3. 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that
are related to an adverse treatment outcome.
4. Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because the
patients will be aware that the dominant tumor will be targeted with higher radiation
dose (compared to those pts who were treated on standard arm prior to its closure).
Phase
Phase 2/Phase 3
Funding Agency/Sponsor
Institutional
Disease
Prostate, Bladder, and Kidney Cancers
Enrollment Eligibility
Inclusion Criteria:
1. Prostate cancer patients with a PSA after prostatectomy of at least 0.1 ng/mL and up
to 4.0 ng/mL within 3 months prior to enrollment.
2. Patients with or without palpable abnormalities on digital rectal exam (DRE) are
eligible.
3. Minimum of 3 months since prostatectomy to allow for return of urinary continence and
healing.
4. Imaging detectable lesion or lesions in prostate bed or regional lymph node (LN). Each
lesion should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months
prior to protocol entry or enrollment.
5. No evidence of metastatic (distant) disease (pelvic nodes are allowed up to common
iliac).
6. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior
to protocol entry or enrollment.
7. No previous pelvic radiotherapy.
8. Serum total testosterone taken within 3 months prior to enrollment.
9. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage
chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If
a prior malignancy is in remission for ≥ 3 years then the patient is eligible.
10. Ability to understand and the willingness to sign a written informed consent document.
11. Zubrod performance status < 2.
12. Patients must agree to fill out quality of life/psychosocial questionnaires.
13. Age ≥ 35 and ≤ 85 years.
Exclusion Criteria:
a. Prior androgen deprivation therapy is not permitted if it was within 6 months previous
to signing consent form. (NOTE: Therapy given as part of the planned course of radiation is
allowed).