Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this research study is to learn about: 1) How standard radiation treatment to
prostate (primary radiotherapy) or the pelvis after prostatectomy (postoperative
radiotherapy) may cause changes in MRI and PET imaging traits that might be used in the
future to predict response. 2) Comparison of such MRI and PET imaging traits with the number
of circulating tumor cells (CTCs) present in the blood prior to treatment and the changes in
these counts after treatment. 3) How MRI and PET imaging characteristics and changes are
related to the expression of genes in the cancer tissue obtained before treatment from
prostate biopsy or a prior prostatectomy before treatment. 4) How the response of prostate
cancer treatment relates to the imaging and CTC changes.
Phase
N/A
Funding Agency/Sponsor
Externally Peer-Reviewed
Disease
Prostate, Bladder, and Kidney Cancers
Enrollment Eligibility
Inclusion Criteria:
1. Pathologic confirmation of prostate cancer.
2. Any T-stage.
3. By imaging or clinical criteria, any patient with disease staging of N0/N1 and M0/M1.
- Patients with metastatic disease are encouraged to participate.
4. Any Gleason Score will be eligible.
5. Androgen deprivation therapy (ADT) is at the discretion of the treating physician, but
must be declared as none, short-term, long-term, or extended prior to enrollment. The
length is calculated from the LHRH (agonist injection). If ADT is planned (based on
treating physician preference), the following restrictions apply:
- Short term ADT is defined as ≤ 7 months;
- Long term ADT is defined as > 7 months and ≤ 36 months;
- Extended ADT is defined as >36 months (e.g., M1 patients).
6. Prostate-specific antigen (PSA) ≤100 ng/mL within (+/-) 4 months of signing of
consent. If PSA was above 100 and drops to <100 with antibiotics, this is acceptable
for enrollment.
7. No previous pelvic radiotherapy.
8. The ability to understand and the willingness to sign a written informed consent
document
9. Zubrod performance status ≤ 2 (Karnofsky or ECOG performance status may be used to
estimate Zubrod):
10. Age ≥ 30 at signing of consent.
11. Subjects must be planned to receive radiation therapy or to undergo prostatectomy.
12. Subjects treated primarily with RT are recommended to have had an MUFgBx prior to
radiation treatment.