Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients
Recruiting · NCT02997709 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Pathologic confirmation of prostate cancer.
- Any T-stage.
- By imaging or clinical criteria, any patient with disease staging of N0/N1 and M0/M1.
- Patients with metastatic disease are encouraged to participate.
- Any Gleason Score will be eligible.
- 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).
- 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.
- No previous pelvic radiotherapy.
- The ability to understand and the willingness to sign a written informed consent document
- Zubrod performance status ≤ 2 (Karnofsky or ECOG performance status may be used to estimate Zubrod):
- Age ≥ 30 at signing of consent.
- Subjects must be planned to receive radiation therapy or to undergo prostatectomy.
- Subjects treated primarily with RT are recommended to have had an MUFgBx prior to radiation treatment.
Where it is running
1 location listed across 1 US state.
- University of Miami - Miami, Florida, United States