Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 12/9/2018 |
| Start Date: | June 24, 2016 |
| End Date: | June 2026 |
Collection and Measurement of Blood and Imaging Biomarkers in Patients Undergoing Standard Primary and Postoperative Radiotherapy for Prostatic Neoplasms - The Miami CoMBINe Trial
Prostate cancer is the most common malignancy in men and nearly 30,000 men die from the
disease each year. Not only is there significant mortality, there is considerable morbidity
from primary and salvage therapies. Understanding which patients require intensified
treatment, as well as those who may not, would improve outcomes on multiple levels. The
cohort to be investigated will be composed of men diagnosed with prostate cancer who are
planned to be treated with (i) external beam radiotherapy to the prostate (primary treatment)
(ii) prostatectomy or (iii) postoperative radiotherapy (adjuvant or salvage treatment
post-prostatectomy). Adjuvant postoperative radiotherapy is defined as men having a PSA<0.1
ng/mL and salvage postoperative radiotherapy as those having a PSA ≥0.1. The overarching
objective of the CoMBINe trial is to identify pre-treatment and post-treatment prognostic and
predictive factors derived from quantitative imaging prostate or prostate bed features, tumor
tissue gene expression signatures, and circulating tumor cells (CTCs). The CoMBINe trial is a
sister trial to another study, termed BLaStM (IRB# 20140627), in men who are candidates for
primary radiotherapy. CoMBINe also allows for men with oligometastasis who are sometimes
treated with RT to the prostate primarily or the prostate bed after prostatectomy who have
limited metastatic sites of disease.
disease each year. Not only is there significant mortality, there is considerable morbidity
from primary and salvage therapies. Understanding which patients require intensified
treatment, as well as those who may not, would improve outcomes on multiple levels. The
cohort to be investigated will be composed of men diagnosed with prostate cancer who are
planned to be treated with (i) external beam radiotherapy to the prostate (primary treatment)
(ii) prostatectomy or (iii) postoperative radiotherapy (adjuvant or salvage treatment
post-prostatectomy). Adjuvant postoperative radiotherapy is defined as men having a PSA<0.1
ng/mL and salvage postoperative radiotherapy as those having a PSA ≥0.1. The overarching
objective of the CoMBINe trial is to identify pre-treatment and post-treatment prognostic and
predictive factors derived from quantitative imaging prostate or prostate bed features, tumor
tissue gene expression signatures, and circulating tumor cells (CTCs). The CoMBINe trial is a
sister trial to another study, termed BLaStM (IRB# 20140627), in men who are candidates for
primary radiotherapy. CoMBINe also allows for men with oligometastasis who are sometimes
treated with RT to the prostate primarily or the prostate bed after prostatectomy who have
limited metastatic sites of disease.
Treatment: Prostatectomy, radiotherapy technique, radiotherapy dose, and the use of androgen
deprivation therapy (ADT), are per the standard of care at the University of Miami, and are
not specified in this protocol.
Measurements: Prior to treatment and at 3 months, 6 months, and at 2.0-2.5 years after
treatment, the patients will have blood drawn for CTCs and additional blood stored for future
studies. Multiparametric MRI (mpMRI) and potentially PET/CT (depending on funding) will be
done at these same time points. Health related quality of life is also being assessed at
these time points.
Overarching goal: To determine the relationships to quantitative imaging features (imaging
biomarkers) to blood based biomarkers and tissue based gene expressions marker/signatures, as
well as to patient outcome.
deprivation therapy (ADT), are per the standard of care at the University of Miami, and are
not specified in this protocol.
Measurements: Prior to treatment and at 3 months, 6 months, and at 2.0-2.5 years after
treatment, the patients will have blood drawn for CTCs and additional blood stored for future
studies. Multiparametric MRI (mpMRI) and potentially PET/CT (depending on funding) will be
done at these same time points. Health related quality of life is also being assessed at
these time points.
Overarching goal: To determine the relationships to quantitative imaging features (imaging
biomarkers) to blood based biomarkers and tissue based gene expressions marker/signatures, as
well as to patient outcome.
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 ≥35 and ≤85 years 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.
We found this trial at
1
site
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Alan Pollack, MD, Ph.D.
Phone: 305-243-4916
University of Miami A private research university with more than 15,000 students from around the...
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