Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
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|ClinicalTrials.gov Identifier: NCT04631744|
Recruitment Status : Not yet recruiting
First Posted : November 17, 2020
Last Update Posted : December 24, 2020
The purpose of this study is to determine what effects (good and bad) cabozantinib has in treatment of patients with metastatic castrate resistant prostate cancer (mCRPC).
The hypothesis for this trial is that cabozantinib has anti-tumor activity in a molecularly-selected group of patients with CRPC.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Cabozantinib||Phase 2|
This is a single-arm, open-label Phase II multi-institutional trial in 30 patients that have been molecularly selected based on that their tumors possess alterations in molecular targets of cabozantinib. Patients will be treated be continuously until they develop radiographic progression or discontinue cabozantinib for toxicity. If 6 or more out of 12 subjects with particular mutation or gene amplification show progression prior to 6 months, accrual for the particular genomic alteration may close. In addition, a series of correlative studies will be performed including tissue biopsies in order to further define the mechanisms of cabozantinib anti-tumor action in prostate cancer and identify surrogate markers of response.
This research study is being done because additional effective treatments are needed for prostate cancer that has spread and is growing despite hormone suppression. Prior studies indicate that Cabozantinib may be effective in a subset of these participants, but that has not yet been determined.
About 30 subjects will take part in this study at 4 participating sites. We expect to enroll approximately 20 participants at Weill Cornell Medicine and approximately 3-5 subjects per participating site. All subjects participating in this study will be treated with Cabozantinib. All subjects will continue to take LHRH analogue therapy.
Once eligible participants will be enrolled on the trial for approximately approximately 12 months. At that point, subjects will switch to long-term follow up for two years after removal from the study or until death, whichever occurs first.
Study related procedures can be combined with routine Standard of Care (SOC) visits. These will include obtaining medical history, vitals, routine blood collection, radiographic imaging (CT, MRI and Bone scan), EKG and between 2 and 4 weeks after starting therapy, a tumor biopsy is required. This will be done with a needle by local sedation by an Interventional Radiologist.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Phase II Trial of Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Known Amplifications or Activating Mutations in Gene Targets of Cabozantinib Who Have Received Prior Anti-Androgen Therapy|
|Estimated Study Start Date :||February 15, 2021|
|Estimated Primary Completion Date :||November 15, 2024|
|Estimated Study Completion Date :||November 15, 2025|
|Experimental: Cabozantinib Arm||
Subjects will receive cabozantinib orally at a (starting) dose of 40 mg once daily
- Change in radiographically progression-free survival following treatment with Cabozantinib radiographically progression-free after 6 months [ Time Frame: Will be assessed at 6 months ]Progression-free survival is defined as the time from randomization to minimum of radiographic progression or death, whichever occurs first. Radiographic response rate will be captured through radiographic scans such as MRI, CT and bone scans. Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications.
- Change in prostate specific antigen (PSA) [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]PSA decline by with Prostate Cancer Working Group 3 (PCWG3) modifications
- Change in adverse event rate response rate [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 is used to grade all adverse events
- Change in overall survival (OS) [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]Overall survival will be captured through in-clinic or telephone contact with subjects
- Proportion of patients with circulating tumor cells (CTC) response [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing
- Proportion of patients with a tumor response [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]Modified response evaluation criteria in solid tumors (RECIST) criteria will be use to determine complete response (CR) or partial response (PR)
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): NCT04631744
|Contact: GUONC Research Teamfirstname.lastname@example.org|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator: Himisha Beltran, MD|
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Contact: Brenda Dickow, RN 313-576-9372 email@example.com|
|Principal Investigator: Elisabeth Heath, MD|
|United States, New York|
|Columbia University Irving Medical Center|
|New York, New York, United States, 10032|
|Contact: Brianne Bodin, BSN, RN, OCN 212-342-5162|
|Principal Investigator: Mark N Stein, MD|
|Weill Cornell Medicine|
|New York, New York, United States, 10065|
|Contact: GUONC Research Team firstname.lastname@example.org|
|Principal Investigator: David M Nanus, MD|
|Principal Investigator:||David M Nanus, MD||Weill Cornell Medicine|