Prostate Cancer Clinical Trial
Official title:
Precision Oncology and Molecular Targeting in Advanced Genitourinary Cancers: Identifying Predictive Markers of Response (The "PROMOTE" Study)
This is a tissue and blood collection protocol requiring image-guided biopsies of metastatic prostate cancer and other genitourinary malignancies including renal cell carcinoma and urothelial carcinoma. Whenever possible, a new bone lesion or new/progressing soft tissue lesion will be chosen for biopsy as opposed to radiographically stable lesion. Patients will be enrolled in into one of several parallel cohorts based upon disease status or type and the planned systemic therapy following baseline tumor biopsy: (A) Androgen signaling inhibition, (B) Immunotherapy, (C) Radiotherapy, (D) Targeted Therapy/Investigational therapeutic, (E) DNA damage response pathway, (F) Aggressive variant disease, (G1) Castration-sensitive ADT naïve and ADT < 3 months), or (G2) Castration-sensitive pre-treated with sub-optimal PSA nadir >0.2 ng/ml, (R) metastatic renal cell carcinoma and metastatic and (U) urothelial carcinoma.
After performing tumor biopsies and blood collection and processing the biopsies and research blood for comprehensive molecular analysis using established methods for RNA and DNA analysis, we will use Pathway Recognition using Data Integration on Genomic Models (PARADIGM) and Differential Pathway Signature Correlation (DiPSC), computational approaches to pathway activity and predictive signature identification developed at University of California, Santa Cruz. We will also collect blood samples (for circulating tumor DNA, plasma, and serum) and circulating tumor cells from participating patients. Residual paraffin- embedded blocks, frozen tissue, and blood products (serum, plasma, and circulating cells) will be stored in a repository for future testing of candidate predictive markers identified during microarray analysis. We will utilize only Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories(e.g. Strata Oncology) to identify genetic mutations within mCRPC tumors to provide genetic information that can be returned to patient to potentially inform treatment decisions. Certain genomic sequencing will be performed by Strata Oncology. Following biopsy and baseline peripheral blood collection, patients will be treated per investigator discretion, with treatment corresponding to assigned patient cohort and initiated within 42 days following baseline tumor biopsy and/or research blood collection. Patients will be evaluated for response to therapy per the standard of care for their specific disease type; such as with monthly serum PSA measurements (may be done at UCSF or at local laboratory) and/or restaging scans (bone scan + CT abdomen/pelvis) (UCSF or local radiology facility). Outcomes on treatment post-biopsy will be recorded, including maximal PSA decline, date of radiographic progression. At the time of disease progression by Prostate Cancer Working Group 2 (PCWG2) criteria for prostate cancer patients, or by RECIST v1.1 for patients with metastatic renal or urothelial cancer, patients may undergo optional repeat assessment for metastatic tumor biopsy, along with mandatory blood collection for analysis of circulating tumor DNA and circulating tumor cells (CTCs). Following second biopsy at progression, patients should continue to be followed for response to subsequent therapy. Patients will be followed every 6 months for updates on disease status including post-study therapies and survival status via telephone calls and/or chart review. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |