This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
Patients will be stratified by PSA doubling time (\< 3 months vs. 3-9 months) and randomized in 1:1:1 fashion to one of three treatment arms: (1) Control arm consisting of LHRH analogue monotherapy (degarelix or leuprolide), (2) Experimental arm consisting of apalutamide in combination with LHRH analogue, and (3) Experimental arm consisting of apalutamide, abiraterone acetate + prednisone, and LHRH analogue. Patients will be treated for a maximum duration of 52 weeks and then enter follow up phase until the time of PSA progression, development of metastasis, or patient withdrawal from study, whichever occurs first. Patients with PSA progression will be followed long term until the development of castration resistance, first metastasis, and death. The primary endpoint of the study is PSA progression-free survival in the intent-to-treat patient population. PSA progression during the 52-week treatment period is defined as a rising PSA confirmed on repeat measurement, and at least 25% and 2 ng/mL above nadir or baseline, whichever is lower. PSA progression during follow up defined as PSA \> 0.2 ng/mL confirmed by repeat measurement at least 2 weeks later. Secondary study endpoints include PSA progression-free survival in testosterone-evaluable population, 36-month PSA progression-free survival rate in both intent-to-treat and testosterone-evaluable populations, time to testosterone recovery, time to castration resistance, metastasis-free survival, quality of life, and safety. Each experimental arm will be compared against the control arm in pair-wise fashion. The study is not powered to detect differences in primary or secondary endpoints between the two experimental arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
504
Take apalutamide 240 mg (four 60 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.
Patients will receive a LHRH analogue therapy of either Degarelix OR Leuprolide with bicalutamide. Degarelix: Patients will receive subcutaneous injections every 28 days (+/- 3 days). Patients will receive a loading dose of 240 mg (two 120 mg injections) on C1D1, followed by maintenance dose of 80 mg on Day 1 of subsequent cycles. Leuprolide: Patients treated with leuprolide will receive a 7.5 mg IM injection on C1D1. Patients in arm A ONLY will take this in combination with bicalutamide 50 mg orally once daily starting on C1D1 and continuing for 28 days through completion of cycle 1. Starting on C2D1, patients will continue on one of the following two treatments at investigator discretion: 1. Leuprolide 7.5 mg IM injection on Day 1 of subsequent cycles without concurrent bicalutamide. OR: 2. Leuprolide 22.5 mg IM injection at the following visits without concurrent bicalutamide: C2D1, C5D1, C8D1, and C11D1.
PSA progression-free survival in the intent-to-treat population
To compare PSA progression-free survival in each of the experimental arms (LHRH analogue + apalutamide; LHRH analogue + apalutamide +abiraterone acetate) versus the control arm (LHRH analogue) among all randomized patients (intent-to-treat population).
Time frame: 36 months
PSA progression-free survival in the testosterone-evaluable population
Compare PSA progression-free survival in testosterone-evaluable population in each experimental arm versus the control arm. Testosterone-evaluable population includes all patients who achieve serum testosterone recovery to \> 50 ng/dL with subsequent PSA measurements sufficient for evaluation
Time frame: 36 months
PSA progression-free survival in both the intent-to-treat and testosterone-evaluable populations
To compare the 36-month PSA progression-free survival rate in each experimental arm versus the control arm in both the intent-to-treat and testosterone-evaluable populations.
Time frame: 36 months
Serum testosterone
To compare the time to recovery of serum testosterone to greater than 50 ng/dL in each experimental arm versus the control arm.
Time frame: 12 months
Time to castration resistance
To compare the time to castration resistance in each experimental arm versus the control arm.
Time frame: 6 years
Metastasis-Free Survival
To compare metastasis-free survival in each experimental arm versus the control arm.
Time frame: 6 years
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Take abiraterone acetate 1000 mg (four 250 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.
Take two prednisone 5 mg tablets daily, starting on C1D1 and continuing throughout the 52-week treatment period. Following completion of treatment period, patients will taper off prednisone per institutional guidelines. Suggested tapering plan: prednisone 5 mg daily for 7 days, then 2.5 mg daily for 7 days before discontinuing.
The Mayo Clinic - Phoenix
Phoenix, Arizona, United States
Sharp Memorial Hospital
Chula Vista, California, United States
City of Hope National Medical Center
Duarte, California, United States
Palo Alto Medical Foundation
Fremont, California, United States
VA Central California Health Care System
Fresno, California, United States
Sharp Memorial Hospital
La Mesa, California, United States
Palo Alto Medical Foundation
Mountain View, California, United States
Palo Alto Medical Foundation
Palo Alto, California, United States
University of California San Diego - Moores Cancer Center
San Diego, California, United States
Sharp Memorial Hospital
San Diego, California, United States
...and 59 more locations
Overall Survival
To compare overall survival in each experimental arm versus the control arm.
Time frame: 6 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To characterize the safety profile in each treatment arm
Time frame: 6 years
Quality of life Expanded Prostate Cancer Index Composite (EPIC)
Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 72 months
Quality of life Hot Flash Daily Interference Scale (HFRDIS)
Hot Flash Daily Interference Scale (HFRDIS)
Time frame: 72 months
Quality of life EQ-5D-5L
EQ-5D-5L
Time frame: 72 months
Quality of life PROMIS Fatigue
PROMIS Fatigue
Time frame: 72 months
Quality-adjusted survival
To compare the quality-adjusted survival (overall survival multiplied by utility score) of patients in each experimental arm versus the control arm.
Time frame: 72 months