Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer
Status:
Withdrawn
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
This study is open to men who have biochemical recurrence (BCR, increased PSA) following
local treatment of their prostate cancer. Androgen deprivation therapy (ADT) is a standard
treatment option, but is only effective for 16-24 months and has a number of side effects
that impact quality of life. These side effects may include fatigue, hot flushing, loss of
sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia (low
levels of red blood cells that can make people feel tired and weak), diabetes (low blood
sugar), heart disease, metabolic syndromes (sometimes called "pre-diabetes" and includes
obesity, increased blood pressure, high levels of cholesterol and triglycerides in blood),
and risk of fractures. An alternative to continuous ADT is intermittent administration, where
patients are given "breaks" from ADT to let their testosterone levels return to baseline.
There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer
time to the development of resistance; (2) improved patient quality of life owing to recovery
from adverse effects, particularly sexual function; and (3) substantial cost savings owing to
less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug.
Apalutamide is an investigational drug, which means it has not been approved by the Food and
Drug Administration (FDA). It is an antitumor drug, taken by mouth. The purpose of this study
is to determine the ability of Apalutamide to extend the time between the first two
injections of leuprolide and improve quality of life. This study will also look at the safety
of Apalutamide and the effects that Apalutamide has on prostate cancer.
Men will be randomized (like flipping a coin) to receive:
- Group A: Leuprolide + Apalutamide or
- Group B: Leuprolide only (until second leuprolide injection), then leuprolide +
Apalutamide 45 men will be in Group A and 21 men will be in Group B. Leuprolide is given
as an intramuscular shot that lasts for 3 months intermittently and Apalutamide is taken
by mouth (4 tablets) daily. Each cycle is 4 weeks long.
Intermittent treatment with Apalutamide + leuprolide will continue until continuous
leuprolide is needed to maintain undetectable PSA levels (i.e., PSA levels rise above
undetectable level unless leuprolide is given without pause, every 3 months).
Phase:
Phase 2
Details
Lead Sponsor:
Robert J Amato The University of Texas Health Science Center, Houston