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Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at changes in MRI and PET scans and cancer cells in the blood after radiation for prostate cancer. It also compares these changes with genes in cancer tissue and how well treatment works. It is for people age 30 or older with prostate cancer who plan to have radiation or surgery to remove the prostate.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 30 or older and have prostate cancer confirmed by a tissue test.
  • Any tumor stage or Gleason score (a measure of how abnormal cancer cells look) is allowed. Cancer may or may not have spread to lymph nodes or other parts of the body.
  • Plan to have radiation treatment or surgery to remove the prostate.
  • Your doctor may choose hormone treatment that lowers testosterone. Before joining, the plan must be listed as none, short-term (7 months or less), long-term (over 7 through 36 months), or extended (over 36 months).
  • Have a PSA blood test result of 100 ng/mL or less within 4 months before or after signing consent. A result above 100 is allowed if it falls below 100 after antibiotics.
  • Have had no radiation treatment to the pelvis, the lower part of the belly.
  • Be able to care for yourself and be up and about at least half of your waking hours, with a Zubrod activity score of 2 or less.
  • Be able to understand the study and be willing to sign a consent form.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official 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.

    Study sites (1)

    FL

    • University of Miami · Miami, FL 33136Pavel Noa Hechevarria · Study contact · 305-243-1036 · pavel.noa@med.miami.eduAlan Pollack, MD, Ph.D. · Principal investigatorMatthew Abramowitz, MD · Principal investigatorRadka Stoyanova, Ph.D. · Principal investigatorMore trials in Miami