Ignite Creation Date:
2024-05-06 @ 2:28 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02059213
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2014-02-07
Brief Title:
A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
A Randomized Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Hormone-Sensitive Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will look at the effect of adding the drug Palbociclib to CAD Combined Androgen Deprivation therapy in patients with RB Retinoblastoma Protein positive hormone sensitive prostate cancer
The investigators hypothesize that the addition of Palbociclib to initial ADT Androgen Deprivation Therapy in patients with newly metastatic RB-positive prostate cancer may significantly increase the efficacy of ADT
The investigators hypothesize that the addition of Palbociclib to initial ADT Androgen Deprivation Therapy in patients with newly metastatic RB-positive prostate cancer may significantly increase the efficacy of ADT
Detailed Description:
Patients will undergo exams tests and procedures to determine if they are eligible to participate Subjects will be randomized to one of two groups Patients randomized to Arm 1 - Patients will receive the LHRH agonist every 3 months Patients will also take 50 mg of bicalutamide by mouth every day Bicalutamide comes in tablet form This arm is broken down into periods of time called cycles starting with cycle 1 then cycle 2 and so onEach cycle is 28 days long If randomized to Arm 2 - Patients will receive the LHRH agonist every 3 months Patients will also take 50 mg of bicalutamide by mouth every day Patients will also take 125 mg of Ibrance daily for 21 days and then will stop taking Ibrance for 7 days Patients will then begin taking Ibrance again after 7 days off Patients will keep repeating this cycle every 28 days When the patient starts the first 28 day cycle that will be cycle 1 then cycle 2 and so on During each cycle the patient will come in for routine and research tests and procedures for patient safety to see how patients are doing and for research purposes The researchers will ask patients to complete a drug diary to track bicalutamide and Ibrance administration The total time of study participation depends on how a patient responds to the study medications Patients may be on the study for a short period of time such as a week or for a longer period of time such as a few years Patients may continue on study treatment until one of the following cancer progresses gets worse another illness or condition develops that prevents study participation unacceptable side effects occur drug is delayed more than 4 weeks patient withdraws consent the study doctor thinks the patient should stop the patient does not follow researchers instructions the study is cancelled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HUM00082715 | OTHER | University of Michigan | None |