Status:
COMPLETED
Prospective CiRculating prOstate Cancer Predictors in HighEr Risk mCRPC studY
Lead Sponsor:
Duke University
Collaborating Sponsors:
Weill Medical College of Cornell University
Johns Hopkins University
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
This study will develop a first-in-man CTC-based molecular taxonomy of CRPC in the context of novel AR-directed therapies, categorize different patterns of resistance in this disease setting, and desc...
Detailed Description
The study will construct a multi-center clinical database of men before and after treatment with abiraterone acetate, enzalutamide, and taxane chemotherapy, and will comprehensively analyze CTC DNA fo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 14 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02269982
Start Date
May 14 2015
End Date
April 30 2019
Last Update
June 10 2019
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Chicago
Chicago, Illinois, United States, 60637
2
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Weill Medical College of Cornell University
New York, New York, United States, 10065