Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

Launched by UNIVERSITY OF MIAMI · Dec 15, 2016

Keywords

ClinConnect Summary

This clinical trial is studying how radiation treatment for prostate cancer affects certain imaging tests, like MRI and PET scans, and how these changes might help predict how well the treatment is working. Researchers want to see if the number of circulating tumor cells (CTCs) in the blood, which are cancer cells that have broken away from the original tumor, can also provide useful information when compared to the imaging results. Additionally, they will look at how these imaging changes relate to the genes present in the cancer tissue taken from patients before treatment.

To participate in this trial, men aged 30 and older who have been diagnosed with prostate cancer can enroll, as long as they meet certain criteria. This includes having a confirmed diagnosis, a specific level of prostate-specific antigen (PSA), and no prior pelvic radiation treatment. Participants can expect to undergo imaging tests and provide blood samples throughout the study, helping researchers gain valuable insights into how prostate cancer treatments work. Your involvement could contribute to improving future treatments for other patients facing this condition.

Gender

MALE

Eligibility criteria

• 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.