Understanding biomarkers in prostate cancer patients undergoing radiotherapy

Collection and Measurement of Blood and Imaging Biomarkers in Patients Undergoing Standard Primary and Postoperative Radiotherapy for Prostatic Neoplasms - The Miami CoMBINe Trial

This study is trying to see how radiation treatment for prostate cancer affects imaging results and tumor cells in the blood to help predict how well the treatment works.

Quick facts

• Study type: Observational
• Enrollment: 144 (estimated)
• Ages: 30 Years and up
• Sex: Male
• Sponsor: University of Miami (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT02997709 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate how standard radiation treatments for prostate cancer affect MRI and PET imaging traits, which may help predict treatment responses. It will compare these imaging traits with the number of circulating tumor cells (CTCs) in the blood before and after treatment. Additionally, the study will explore the relationship between imaging characteristics and gene expression in cancer tissue obtained from biopsies or prior surgeries. The goal is to better understand how treatment responses correlate with changes in imaging and CTC counts.

Who should consider this trial

Good fit: Ideal candidates include men with pathologically confirmed prostate cancer, regardless of T-stage or Gleason Score, who have not received previous pelvic radiotherapy.

Not a fit: Patients with prior pelvic radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved methods for predicting treatment responses in prostate cancer patients.

How similar studies have performed: Other studies have shown promise in using imaging and biomarkers to predict treatment responses in cancer, suggesting this approach may be beneficial.

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.

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Alan Pollack, MD, PhD — University of Miami
• Study coordinator: Pavel Noa Hechevarria

Conditions Prostate Cancer; Circulating Tumor Cells; CTCs; Androgen Deprivation Therapy; ADT