RECRUITING

Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

Conditions

Prostate Cancer Circulating Tumor Cells CTCs Androgen Deprivation Therapy ADT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-06-24

Study Completion:2031-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02997709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Pavel Noa Hechevarria

CONTACT

305-243-1036

pavel.noa@med.miami.edu

Principal Investigator

Alan Pollack, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Alan Pollack, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-06-24

Study Completion Date2031-06

Study Record Updates

Study Start Date2016-06-24

Study Completion Date2031-06

Terms related to this study

Keywords Provided by Researchers

Circulating Tumor Cells
CTCs
Androgen Deprivation Therapy
ADT

Additional Relevant MeSH Terms

Prostate Cancer