More Intensified Salvage Regimen for Prostate Cancer Does Not Impair Health-Related Quality of Life

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In patients with biochemically recurrent prostate cancer after radical prostatectomy, a more intensified regimen of abiraterone acetate/prednisone plus apalutamide improved outcomes and did not lead to decrements in specific domains of health-related quality of life (HRQoL) vs treatment with bicalutamide, according to patient-reported outcomes in the phase II FORMULA-509 trial. These findings were presented by Hoffman et al at the 2024 ASCO Genitourinary Cancers Symposium (Abstract 260).

In the original study, the combination of abiraterone acetate/prednisone plus apalutamide showed a trend toward improved progression-free survival and metastasis-free survival compared with bicalutamide, but this difference was not statistically significant. The presentation at the 2024 ASCO Genitourinary Cancers Symposium focused on an analysis of patient-reported outcomes from the trial and found no significant differences between the two treatment arms in terms of hormonal function, fatigue, and cognitive status.

“It is critical that we understand the impact of this more intensified androgen-deprivation regimen [on] patient-reported health-related quality of life, as patients’ experience and perception can differ from physicians’ assessment,” said lead author of the HRQoL analysis Karen Hoffman, MD, of The University of Texas MD Anderson Cancer Center.

Study Details

In the FORMULA-509 study, patients (n = 345) were randomly assigned 1:1 to receive either 6 months of gonadotropin-releasing hormone (GnRH) plus bicalutamide (n = 172) or 6 months of GnRH plus abiraterone and prednisone/apalutamide (n=173). All patients received salvage radiation therapy. For inclusion in the trial, patients had to have a rising prostate-specific antigen (PSA) following prostatectomy, and at least one of the following unfavorable risk factors: Gleason score between 8 and 10;  a PSA level > 0.5 ng/mL; pathologically positive lymph nodes; negative surgical margins; and/or local or regional recurrence on imaging.

Validated HRQoL questionnaires—the Expanded Prostate Cancer Index Composite (EPIC-26), PROMIS Fatigue, and Saint Louis Un­iversity Mental Status Exam (SLUMS)—were given to participants at baseline, at the end of treatment, and 1 year after completing treatment. The tests measured hormone function, fatigue, and cognitive impairment.

Sexual Function, Fatigue, and Cognitive Impairment

In terms of sexual function as measured by EPIC-26, there were no significant differences between the two treatment arms at any of the three time points assessed. However, Dr. Hoffman pointed out that these men all had low sexual function at baseline, with only 21% able to maintain an erection sufficient for vaginal penetration.

“With subsequent improvement towards baseline at 1 year, there was no difference in patient-reported hormonal function between the treatment arms at end of treatment and 1 year after completion of treatment,” Dr. Hoffman said.

Similar to sexual function, there was no significant difference in patient-reported fatigue. Median scores for PROMIS Fatigue were not significantly different between the two treatment arms at any time point.

The median scores for SLUMS were 27 in both the bicalutamide and abiraterone acetate plus prednisone/apalutamide arms at baseline, 28 for both arms at the end of treatment, and 27 in both arms at 1 year follow-up.

“Given these favorable patient-reported health-related quality-of-life outcomes, 6 months of intensified androgen-deprivation therapy with next-generation antiandrogens is an attractive treatment alternative to long-duration androgen-deprivation therapy for patients with rising PSA and unfavorable features after prostatectomy,” Dr. Hoffman stated.

Disclosure: For full disclosures of the study authors, visit

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