Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT02997709

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 30+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT02997709

Start date

Jun 24, 2016

Status verified date

Mar, 2026

Completion date

Jun 30, 2032

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30+

Healthy Volunteers: Not accepted

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 Design

Enrollment

144 participants

Anticipated

Interventions and Outcome Measures

Arms

Radiation Therapy Group

Participants with prostate cancer diagnosis who are scheduled to undergo radiotherapy (definitive or palliative) with or without the addition of Androgen Deprivation Therapy (ADT) will be evaluated

Prostatectomy Group

Participants with prostate cancer diagnosis who are scheduled to undergo prostatectomy will be evaluated.

Primary outcome measure

  • Comparison of Pre- and Post-Treatment Quantitative Imaging Parameters to Changes in Circulating Tumor Cells Over Time in Study Participants. [ Time Frame: Baseline, within 8 Days Prior to End of RT, 3 months Post-RT, 9 months and 2-2.5 Years Post-RT ]

Central Contacts and Locations

Central contacts

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Alan Pollack, MD, Ph.D.

More Information

Sponsor

University of Miami

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • Circulating Tumor Cells
  • CTCs
  • Androgen Deprivation Therapy
  • ADT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-04.