No PSA Recurrence at 24 Months With Apalutamide Plus ADT After Radical Prostatectomy

SAN ANTONIO — Bigger than 2 years after treatment, no patient with excessive-risk prostate cancer had a confirmed biochemical recurrence after receiving postoperative apalutamide (Erleada) and androgen deprivation treatment (ADT), in accordance with a single-arm, section II gaze.

Two unconfirmed recurrences occurred at 24 and 30 months. Including those conditions resulted in a 24-month biochemical recurrence-free survival (BCRFS) of 98.4%, growing to a most practical likely 100% when most practical likely confirmed conditions have been notion of, reported Jason Hafron, MD, of the Michigan Institute for Urology in Bloomfield, Michigan, on the American Urological Association annual meeting.

“You infrequently ever ever gaze a flat Kaplan-Meier curve,” said Hafron. “All all over again, no patient had a confirmed BCR 2 years after radical prostatectomy, outlined as two consecutive PSA [prostate specific antigen] values bigger than 0.2 nanograms per milliliter.”

“The naysayers in this room would insist ‘Of direction you would possibly additionally maybe be going to have an undetectable PSA. They have been on apalutamide and ADT,'” he added. “But please realize that 76% of the sufferers had a testosterone restoration of larger than or equal to 150 nanograms per deciliter 12 months after finishing treatment, and 95% of the sufferers at 12 months had testosterone ranges bigger than or equal to 50 nanograms per deciliter.”

About 15% of newly identified prostate cancers meet requirements for excessive risk, and 45-65% of those cancers recur interior 5 years after radical prostatectomy, Hafron neatly-known in his introduction. The selective androgen receptor inhibitor apalutamide is being evaluated in two registrational trials of excessive-risk localized prostate cancer handled with prostatectomy or radiation treatment.

Hafron reported findings from the trial of postoperative apalutamide plus ADT in males present process radical prostatectomy for excessive-risk localized prostate cancer (outlined as PSA ≥20 ng/mL or one in every of lots of excessive-risk Gleason grades). A retrospective gaze of 3,500 males with excessive-risk prostate cancer showed a 2-year BCRFS of 76% with radical prostatectomy on my own. These results supplied the reference for the present gaze.

Data evaluation integrated 96 sufferers enrolled at 27 web sites within the U.S. They had a postoperative PSA ≤0.2 ng/mL and no proof of metastatic disease. All sufferers got 12 cycles of apalutamide plus ADT. The precious endpoint became BCRFS at 24 months. Secondary endpoints integrated BCRFS at 12 months and serum testosterone restoration to ≥150 ng/dL at 18 and 24 months. Unconfirmed BCR became an exploratory endpoint.

Gleason ranking at diagnosis became 8 in 30% of sufferers and 9 in 57%. The cohort had a median preoperative PSA of seven.6 ng/mL and median testosterone of 340 ng/dL. In accordance to FDA steering referring to clinical trial diversity, 14% of sufferers have been Sad/African American.

The outcomes showed no confirmed PSA recurrences all over the first 24 months after treatment. The 2 unconfirmed events occurred at 24 and 30 months, linked to PSA values of 0.39 and zero.22 ng/mL, respectively.

With respect to testosterone restoration, 35% of sufferers had restoration to ≥150 ng/dL interior 6 months, and 63% had restoration to ≥50 ng/dL, as well to to the 12-month rates of 76.4% and 95.2%.

The most frequent treatment-emergent unfavorable events (TEAEs) have been hot flush (68.5%), fatigue (53.7%), rash (21.3%), COVID-19 (17.6%), and arthralgia (16.7%). The most frequent grade 3 TEAEs (no grade 4) have been fatigue (3.7%), rash (2.8%), and COVID-19 (1.9%). TEAEs leading to discontinuation occurred in 10.2% of the gaze population.

“Remedy intensification with 12 cycles of apalutamide and ADT would possibly perchance additionally radically change an possibility for sufferers with excessive-risk localized prostate cancer who have passed thru radical prostatectomy,” said Hafron.