Progression-free Survival (PFS)
| Group | Value (percentage change of PSA) |
|---|---|
| Abiraterone Acetate | 5.1 |
| Abiraterone Acetate and Degarelix | 17.1 |
| Degarelix | 11.9 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
NCT0175145118 Dec 2012 to 28 Sept 2020
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer who have not received prior chemotherapy. Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly injection, is FDA approved for the treatment of patients with advanced prostate cancer. The purpose of this study is to evaluate abiraterone acetate and prednisone in combination with degarelix as a possible treatment for PSA recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone. This will be the first time these drugs will be used together.
Experimental
Abiraterone acetate
Group 1 * Abiraterone acetate 1000 mg daily x 8 months * Prednisone 5 mg once daily x 8 months
Experimental
Abiraterone acetate and Degarelix
Group 2 Abiraterone acetate 1000 mg daily x 8 months * Prednisone 5 mg once daily x 8 months * Degarelix subcutaneous depot injection q 1 month x 8 months
Experimental
Degarelix
Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months
Outcomes the sponsor listed as primary.
Progression-free Survival (PFS)
Time frame · 18 months
defined as an undetectable PSA (using a routine non-ultrasensitive PSA assay) with non-castrate level of testosterone (\>150 ng/dL) at 18 months from the time of treatment initiation (PSA0).
Soft Tissue Complete Response
Time frame · 1 year
In addition to an undetectable PSA, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (Complete Response per RECIST) in order to meet the criteria for PFS. Outcome in subjects who develop radiographically evident metastatic disease while on study will be considered treatment failures independent of their respective PSA values.
PSA Response Rate
Time frame · 8 months
The percentage of patients with a non-castrate level of testosterone (\>150 ng/dL) and an undetectable PSA at 8 months from PSA0 will be measured.
Overall Quality of Life
Time frame · 1 year
with particular attention to libido, potency, anxiety, depression, hot flashes, and fatigue. Effects of each arm on health-related quality of life will be assessed via PRO Survey (Appendix C) completed on paper by the patient at the following study visits: Up to 30 Days Prior to Randomization, each Day 1 of Treatment Cycle, End of Treatment, and each Post-Treatment Follow-up.Effects of each arm on quality of life,
Non-hematologic Adverse Events
Time frame · 1 year
Safety will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations and clinical laboratory tests throughout the conduct of the study.
Testosterone and Luteinizing Hormone (LH) Recovery Rates
Time frame · 8 -10 months
Testosterone and LH recovery rates will be measured at 8 months from the start of randomization and at each month of the 10 month follow up period.
Correlative Tissue Analysis
Time frame · 1 year
Tissue samples will be utilized for morphologic assessment, percent tumor involvement (if applicable), and immunohistochemistry. The immunohistochemical markers assessed may be AR, PTEN, PSMA, fatty acid synthase (FASN), phospho-AMPK, phospho-ACC, phospho-S6 kinase, phospho-Akt for the assessment of the AMPK, lipid synthesis, mTOR pathways, and immunological markers.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage change of PSA) |
|---|---|
| Abiraterone Acetate | 5.1 |
| Abiraterone Acetate and Degarelix | 17.1 |
| Degarelix | 11.9 |
| Group | Value |
|---|---|
| Abiraterone Acetate | not posted |
| Abiraterone Acetate and Degarelix | not posted |
| Degarelix | not posted |
| Group | Value |
|---|---|
| Abiraterone Acetate | not posted |
| Abiraterone Acetate and Degarelix | not posted |
| Degarelix | not posted |
| Group | Value |
|---|---|
| Abiraterone Acetate | not posted |
| Abiraterone Acetate and Degarelix | not posted |
| Degarelix | not posted |
| Group | Value |
|---|---|
| Abiraterone Acetate | not posted |
| Abiraterone Acetate and Degarelix | not posted |
| Degarelix | not posted |
| Group | Value |
|---|---|
| Abiraterone Acetate | not posted |
| Abiraterone Acetate and Degarelix | not posted |
| Degarelix | not posted |
| Group | Value |
|---|---|
| Abiraterone Acetate | not posted |
| Abiraterone Acetate and Degarelix | not posted |
| Degarelix | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Abiraterone AcetateGroup 1 * Abiraterone acetate 1000 mg daily x 8 months * Prednisone 5 mg once daily x 8 months Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food. | 2 / 42 | 2 / 42 | 5 / 42 |
| Abiraterone Acetate and DegarelixGroup 2 Abiraterone acetate 1000 mg daily x 8 months * Prednisone 5 mg once daily x 8 months * Degarelix subcutaneous depot injection q 1 month x 8 months Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter. | 3 / 40 | 5 / 40 | 5 / 40 |
| DegarelixGroup 3 • Degarelix subcutaneous depot injection q 1 month x 8 months Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. | 0 / 42 | 4 / 42 | 4 / 42 |
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