Prospective CiRculating prOstate Cancer Predictors in HighEr Risk mCRPC studY (PROPHECY)
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|ClinicalTrials.gov Identifier: NCT02269982|
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : June 10, 2019
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|Condition or disease||Intervention/treatment|
|Prostate Cancer||Device: AR-v7 assays|
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||Development of Circulating Molecular Predictors of Chemotherapy and Novel Hormonal Therapy Benefit in Men With Metastatic Castration Resistant Prostate Cancer (mCRPC)|
|Actual Study Start Date :||May 14, 2015|
|Actual Primary Completion Date :||September 1, 2017|
|Actual Study Completion Date :||April 30, 2019|
|men with mCRPC prior to enzalutamide/abiraterone||
Device: AR-v7 assays
- Comparison of median progression free survival (PFS) to AR-v7 status [ Time Frame: 2 years ]
- Determine the prevalence of defined categories of a molecular taxonomy of mCRPC using CTC biomarkers and correlate each to clinical benefit (PSA response, PFS) [ Time Frame: 4 years ]
- Compare levels of circulating epithelial to mesenchymal transition (EMT) and other epithelial plasticity (EP) biomarkers with mCRPC taxonomic categories and clinical outcomes (PSA decline rates, PFS) [ Time Frame: 4 years ]
- Determine molecular lesions in CTCs and ctDNA that consistently emerge during enzalutamide and taxane chemotherapy progression in men with mCRPC [ Time Frame: 4 years ]
- Correlate specific AR-v7 assays with clinical outcomes (PSA decline rates, PFS) [ Time Frame: 4 years ]
- Correlatate other AR-variants with clinical outcomes (PSA decline rates, PFS) [ Time Frame: 4 years ]
- Change in neuroendocrine biomarkers during enzalutamide and taxane progression in men with mCRPC [ Time Frame: 4 years ]
- Associate high CTC heterogeneity with PFS, OS, and CTC genotype/phenotypes [ Time Frame: 4 years ]
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Histologically confirmed diagnosis of adenocarcinoma of the prostate. Pure small cell or neuroendocrine tumors of the prostate are not permitted.
- Clinical or radiographic evidence of metastatic disease.
- Planned therapy with either enzalutamide and/or abiraterone acetate within the coming 6 weeks
- Castrate levels of testosterone (<50 ng/dl) at most recent assessment and/or documented ongoing Androgen Deprivation Therapy for at lease three months.
Evidence of disease progression on or following most recent therapy as evidenced by at least one of the following:
- Radiographic evidence of disease progression as defined by one or more new bone scan lesions that is not consistent with flare/healing, or growth of soft tissue/visceral metastases to greater than one centimeter (cm) in longest diameter (2 cm shortest diameter for lymph nodes).
- Clinical progression as defined by the treating physician (such as pain progression)
- Consecutive PSA rises meeting PSA progression criteria as determined by PCWG2 criteria (increase that is >25% and >2 ng/mL above the nadir, and which is confirmed by a second value 3 or more weeks later)
At least two of the following high risk features during screening for rapid disease progression:
- Anemia with a hemoglobin <12.0 g/dl
- Elevated alkaline phosphatase above the institution upper limit of normal
- High lactate dehydrogenase (LDH) above the upper limit of normal
- Prior therapy with enzalutamide, abiraterone acetate, or orteronel. Patients are not permitted if they are continuing on the same therapy or restarting a therapy that they have been exposed to in the past.
- Presence of visceral metastasis on imaging
- Presence of clinically significant pain requiring opioid analgesia
- Patients with a Cellsearch CTC > 5 cells per 7.5 mL whole blood (if available as standard of care) are eligible without additional high risk features
- PSA doubling time under 3 months on most recent therapy
- Radiographic progression at entry based on new lesion(s) in bone, soft tissue, or visceral metastases
- Age > 18 years.
- Ability to understand and the willingness to sign a written informed consent document.
- History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
- Treatment with an anthracycline or mitoxantrone within 1 week of CTC collection
- Prior docetaxel in the castration resistant metastatic setting. Patients treated with docetaxel for metastatic castration sensitive disease will be eligible.
- Unwillingness to be followed longitudinally for serial CTC biomarker studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269982
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10065|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Andrew J Armstrong, MD||Duke University|
|Responsible Party:||Duke University|
|Other Study ID Numbers:||
|First Posted:||October 21, 2014 Key Record Dates|
|Last Update Posted:||June 10, 2019|
|Last Verified:||June 2019|
Genital Neoplasms, Male
Neoplasms by Site