The findings, announced in a study summary, suggest that combining medication with surgery may delay cancer recurrence or spread in men with high-risk prostate cancer. The substudy enrolled 408 men with high-risk localized or locally advanced prostate cancer.
According to the summary, the combination group had a 62% lower risk of treatment failure, recurrence, cancer spread, or death during the study period. The results add to a growing body of research on intensifying treatment for aggressive prostate cancer, though the combination is not yet standard care.
Serious treatment-related side effects occurred in 31% of the combination group and 22% of the surgery-only group, the study summary stated. The summary did not specify which side effects occurred. The trade-off between improved cancer control and increased toxicity will be a key consideration for patients and their doctors.
Trial Assigned 408 Men to Combination Therapy or Surgery Alone
Researchers randomly assigned 102 men to receive apalutamide and androgen-deprivation therapy over six 28-day cycles before and after surgery, according to the substudy summary. The remaining 306 men had surgery alone. Apalutamide is an androgen receptor inhibitor that blocks testosterone and other hormones that fuel prostate cancer growth. Androgen-deprivation therapy lowers testosterone levels.
The study tracked cancer-related events including signs of treatment failure, recurrence, cancer spread, or death. It also measured time free of cancer spread and the need for additional treatment. Median follow-up was about three years, the report stated, a relatively short period for assessing long-term cancer outcomes.
The substudy was part of the larger PROTEUS trial, which is evaluating apalutamide in various prostate cancer settings. The substudy was open-label, meaning doctors and participants knew which treatment they received, a design that can introduce bias. The summary did not report whether the trial was conducted at multiple sites or in which countries.
Combination Group Had Lower Rates of Recurrence and Spread at Three Years
At three years, 63% of men receiving the combination therapy were free of the tracked cancer-related events, compared with 41% of men who had surgery alone, according to the substudy. The combination group had a 62% lower risk of experiencing one of those events during the study.
Cancer spread was less common in the combination group: 87% remained free of detectable cancer spread at three years, compared with 78% in the surgery-only group. The combination also reduced the risk of needing additional treatment, such as radiation therapy, by 71%, the study summary stated. These findings suggest that the combination may delay the need for further interventions.
The substudy’s results are consistent with other research on combination therapy for prostate cancer. However, that study involved a different patient population and treatment protocol.
Serious Side Effects More Common; Overall Survival Data Pending
The article stated, “There was a trade-off,” noting that serious treatment-related side effects occurred in 31% of men receiving combination therapy, compared with 22% of those who had surgery alone. The study summary did not specify which side effects occurred. Common side effects of apalutamide and androgen-deprivation therapy include fatigue, rash, diarrhea, and hot flashes, but the substudy did not provide a breakdown.
The study was open-label, meaning doctors and participants knew which treatment they received, and follow-up was relatively short for assessing long-term cancer outcomes, according to the report. These limitations could affect the interpretation of the results. Researchers have not yet established whether the combination improves overall survival, and the approach is not yet established as standard care, the summary stated.
The substudy’s findings are promising but preliminary. Larger, longer-term trials with blinded designs are needed to confirm whether the combination extends overall survival and to better characterize its side effect profile. Until then, the combination remains an experimental approach.
Findings Add Evidence; Combination Is Not Standard Care
The substudy findings add evidence that combining treatments may benefit some men with high-risk prostate cancer, according to the report. Earlier research on hormone therapy around prostate surgery produced mixed results, and the combination is not yet standard care. The results are part of a broader effort to improve outcomes for men with aggressive disease.
Treatment decisions depend on the cancer, overall health, and personal priorities. The article listed questions patients may discuss with their oncology teams, such as the potential benefits and risks of adding hormone therapy to surgery, the expected side effects, and the impact on quality of life. These discussions are essential for shared decision-making.
The PROTEUS substudy is one of several ongoing investigations into combination therapy for prostate cancer. Other studies are testing different drugs and treatment sequences. The findings will likely inform future research and clinical practice, but they do not yet change the standard of care.
Reference:
- 63% Of Men Had Better Cancer-Related Outcomes With This Treatment Combo. https://www.mindbodygreen.com/articles/63-of-men-had-better-cancer-related-outcomes-with-this-treatment-combo
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