Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer.

Phase 2

Completed

Conditions: Metastatic Prostatic Adenocarcinoma

Interventions: Drug: Docetaxel
Drug: Degarelix

Registration Number: NCT03069937

Lead Sponsor: Medical University of South Carolina

Brief Summary: The purpose of this study is to look at patient outcomes when docetaxel is started prior to ADT with degarelix.

Detailed Description: This study will look at two drugs, docetaxel and degarelix, which are both FDA approved for the treatment of prostate cancer. Docetaxel is a standard chemotherapy treatment for metastatic prostate cancer. Degarelix is an androgen deprivation therapy (ADT) agent that decreases the amount of testosterone in the body, which helps to fight tumor growth. Usually, docetaxel is given after ADT. This study will look at how your cancer changes when docetaxel is started before ADT. You are being asked to participate in this study because you have metastatic prostate cancer that can be treated with docetaxel and ADT.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Docetaxel + Degarelix	Docetaxel	Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses.
Docetaxel + Degarelix	Degarelix	Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses.

Primary Outcome Measures

Name	Time	Method
PSA Response at 10 Months	10 months	PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least three weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml. PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least three weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.

Secondary Outcome Measures

Name	Time	Method
Frequency of Adverse Events (AEs) Using CTCAE v. 4	10 months	Toxicity for all evaluable patients will be defined by CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0.
PSA Response at 6 Months	6 months	PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least three weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml. PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least three weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.
Frequency of Disease Progression at 12 Weeks Using PSA	12 weeks	PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least two weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir. PSA progression will not be established during the first 12 weeks of therapy (4 cycles of docetaxel) as defined by PCWG2 criteria. Thus subjects with no PSA decline from baseline during therapy will have date of PSA progression defined as first PSA value after 12 weeks that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.
PSA Response at 12 Weeks	12 weeks	PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least two weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml. PSA Partial Response is defined as a decline of PSA from trial baseline of \> 50% for two consecutive measurements at least two weeks apart. Date of partial response will be defined as the date of first recorded decline of \> 50% baseline. PSA progression is defined in outcome 4.
Development of Castration Resistance After Initiation With ADT	10 months	This will be defined as the time from initial Degarelix injection to the time of disease progression (clinical, radiographic or PSA. Determination of castration resistant disease status will require disease progression and a measured serum testosterone level less than 50 ng/dl.
Progression Free Survival	34 months	Progression free Survival (PFS) will be defined as the duration of time from start of study treatment to time of disease progression or death, whichever comes first.
Overall Survival (OS)	34 months	OS is defined as the time interval from trial enrollment to death due to any cause. Survival times will be censored for patients lost to follow-up or still alive at the trial's termination.