Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients (COMBINE)

University of Miami

Status: Enrolling

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02997709

NCI-2019-08552 (Registry Identifier)

20150452

Details and patient eligibility

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.

Enrollment: 144 estimated patients

Sex: Male

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

144 participants in 2 patient groups

Radiation Therapy Group

Description:

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

Description:

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