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An expert explains that the GAP regimen did not improve overall survival in advanced biliary tract cancer versus the doublet and increased severe side effects.

GAP Triplet May Be Less Safe Than Doublet Chemo in Biliary Tract Cancer

For patients with prostate cancer, a high omega-3, low-omega-6 diet with fish oil for one year led to a reduction of prostate Ki-67 index, according to data from the CAPFISH-3 trial, which were presented at the 

The Ki-67 index decreased by 15% for patients who received the specialized diet and fish oil, compared with an increase of 24% in the control group who were instructed not to take fish oil.

“A high omega-3, low omega-6 diet with [fish oil] for one year resulted in a significant reduction in prostate Ki-67 index — compared with the control group — a biomarker for prostate cancer progression, metastasis and death,” first study author and lead investigator, Dr. William J. Aronson, stated in the presentation.

Aronson is a professor in the Department of Urology and chief of Urology at Olive View-UCLA Medical Center and chief of Urologic Oncology at West Los Angeles Veterans Affairs Medical Center.

The CAPFISH-3 trial was a single-center, randomized, open-label phase 2 trial for men who were on active surveillance for grade group 1 or 2 prostate cancer.

A total of 100 patients were randomly assigned to be treated on either the intervention (50 patients) or the control group (50 patients). Of those enrolled, six on the intervention group were not administered the allocated intervention, and three in the control group were not administered allocated intervention.

Diet intervention in the trial consisted of less than 30% of calorie intake from fat; decreased consumption of foods with high levels of omega-6 fatty acids like corn oil, fried foods, highly processed foods and chips; increased intake of omega-3 rich foods like salmon and tuna; a less than 4:1 ratio of omega-6 to omega-3; and 2.2 grams per day of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) intake via four oral fish oil capsules per day. Patients in the control group did not receive fish oil.

Eligible patients had a prostate biopsy performed with the Artemis image-fusion device, adenocarcinoma of the prostate, and elected to undergo active surveillance, according to the study’s Clinical Trial website. Additionally, patients had clinical stage T2c or less; Gleason grade 3 plus 4 or less; a prostate-specific antigen (PSA) less than 25; and a willingness to not consume lycopene, green tea or pomegranate juice/supplements during the one-year study.

Exclusion criteria include a diagnostic prostate biopsy with only one core cancer with less than 5% of tissue involved with cancer; received finasteride or dutasteride during the prior year; taken fish oil during the last three months; prior treatment for prostate cancer; an allergy to fish; and other medical conditions that exclude them from undergoing repeat prostate biopsy at one year.

In the intervention group, the median age was 64 years versus 64.5 years in the control group; maximum 3 plus 3 Gleason score was 35 (70%) and 35 (70%); 3 plus 4 Gleason score was 15 (30%) and 15 (30%); and median PSA was 5.9 and 5.6.

The primary trial end point was the change in Ki-67 index from baseline to one year using the Artemis device from same site biopsies with cancer compared between both trial groups. Secondary end points include pathologic features such as grade group and maximum tumor length, Decipher 22 gene classifier score, serum prostate specific antigen, testosterone, cytokines and lipids.

The trial also yielded reduced levels of triglyceride, reduced macrophage colony-stimulating factor levels, and no change in tumor volume, grade group, PSA and Decipher score.

One limitation of the trial was the duration of the year, and to determine the effects of these results on clinical end points further studies such as phase 3 and longer-term trials are needed.

According to trial investigators, the ratio of omega-6 to omega-3 in the American diet is 15:1, and linoleic acid constitutes 85% of polyunsaturated fat consumed in the American diet.

: “A high omega-3, low omega-6 diet with fish oil for men with prostate cancer on active surveillance: The CAPFISH-3 randomized clinical trial” by Dr. William Aronson, et al. 

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A high omega-3, low omega-6 diet supplemented with fish oil significantly reduced the prostate Ki-67 index in prostate cancer patients, as shown in the CAPFISH-3 trial. This trial, presented at the 2025 ASCO Genitourinary Cancer Symposium, involved 100 men on active surveillance for grade group 1 or 2 prostate cancer. The intervention group experienced a 15% decrease in the Ki-67 index, while the control group saw a 24% increase. The study suggests potential benefits of dietary modification in managing prostate cancer progression.

Among patients with prostate cancer, a high omega-3, low-omega-6 diet with fish oil led to a Ki-67 index decrease. 

Tumor

Conference

High Omega-3 Diet With Fish Oil Reduces Ki-67 Index in Prostate Cancer

Patients with metastatic prostate cancer showed similar prostate-specific antigen (PSA) responded when treated with transdermal estradiol (tE2) patches and androgen receptor pathway inhibitors (ARPIs), such as Zytiga (abiraterone), Xtandi (enzalutamide) or Erleada (apalutamide), compared to treatment with luteinizing hormone releasing hormone analogues (LHRHa) and ARPI, research has shown.

2025 ASCO Genitourinary Cancers Symposium

, support the use of tE2 patches for androgen deprivation therapy (ADT) in prostate cancer management, researchers posit, noting that tE2 patches provide patients with EFT choices about expected toxicity profiles and mode of administration.

“Estrogen is, of course, the oldest anti-cancer drug, dating back to the 1940s and the reason that we're been evaluating transdermal estrogen is that by switching from oral to patches, you abrogate the cardiovascular thromboembolic problems that you see with oral therapies, and you can still, if you use two to three patches, suppress testosterone down to castrate levels,” said presenting author Nicholas David James, of The Institute of Cancer Research and The Royal Marsden Hospital NHS Foundation Trust in London, during a rapid oral abstract presentation of the data at the symposium.

In the multi-arm, multi-stage phase 2 platform STAMPEDE trial, 79 patients with histologically confirmed M1 prostate cancer between October 2020 and March 2023 received either LHRHa+ARPI (41 patients) or tE2+ARPI (38 patients). Baseline characteristics were similar, with median ages of 69 in the LHRA+ARPI arm and 69 in the tE2+ARPI arm, and PSA at baseline of 47 and 39, respectively.

In the LHRHa+ARPI arm, 25 of 41 patients, or 61%, achieved a PSA of 0.2 ng/ml or less, and this was achieved by 23 of 38, of 61%, of patients in the tE2+ARPI arm.

In the LHRHa and tE2 arms, PSA90 rates were 93% versus 95% and PSA50 rates were 100% and 100%. Additionally, 31 of 34, or 91%, of patients treated with tE2 had testosterone of 1.7nj/ml or less at 12 weeks.

“It's effective as measured here, it's safe. There were no safety signals for the interaction. We think it's an alternate therapy choice for men starting ADT,” James said.

Among patients in the LHRHa and tE2 arms, rates of hot flashes of any grade were experienced by 54% and 18% of patients, gynecomastia of any grade was experienced by 10% and 45%, hypertension of any grade was experienced by 20% and 5%, and pruritis of any grade was experienced by 5% and 21%.

In the study, participants were randomly allocated to tE2 patches releasing 100mcg/24hrs, three patches changed twice-weekly once testosterone 1.7ng/ml or less, or standard doses of LHRHa and scheduled to receive ARPIs.

The primary outcome of the study was the proportion of patients who reached a PSA nadir of 0.2ng/ml or less during the first six months, with researchers noting that other PSA parameters, testosterone 1.7ng/ml or less at 12 weeks with tE2, and side effects within the first 12 months (including hypertension, hot flashes and gynecomastia) were assessed.

“The takeaway conclusions are that [tE2] is effective on the measure we've chosen, which is PSA less than 0.2 at 24 weeks,” James said. “It's safe, there were no unexpected adverse events observed, and we think it's a viable alternative choice, particularly for example, if you're self-paying for your medication, but also for other reasons as well, it's very cheap.”

“Transdermal oestradiol (tE2) patches as androgen deprivation therapy (ADT): Efficacy and safety of combining with androgen receptor pathway inhibitors (ARPIs) in metastatic (M1) prostate cancer—Randomised comparison from the STAMPEDE trial platform.” presented by Nicholas David James at the 2025 ASCO Genitourinary Cancers Symposium, Feb. 13-15, San Francisco, California, abstract 21.

Transdermal estradiol (tE2) patches demonstrate comparable efficacy to luteinizing hormone-releasing hormone analogues (LHRHa) when combined with androgen receptor pathway inhibitors (ARPIs) in metastatic prostate cancer treatment. The STAMPEDE trial showed similar prostate-specific antigen (PSA) responses between tE2+ARPI and LHRHa+ARPI groups. tE2 patches offer a favorable safety profile, reducing cardiovascular risks associated with oral estrogen. Patients experienced fewer hot flashes and hypertension with tE2, though gynecomastia was more common. tE2 is a cost-effective alternative for androgen deprivation therapy (ADT), particularly for self-paying patients.

Responses were similar among patients with estrogen patches and ARPIs compared to luteinizing hormone releasing hormone analogues and ARPIs among patients with metastatic prostate cancer.

Estrogen Patches with ARPIs Found to Be Safe, Effective in Prostate Cancer

For patients with metastatic hormone-sensitive prostate cancer (mHSPC), efficacy outcomes were improved following treatment with Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) compared with placebo plus ADT irrespective of disease volume, according to findings from the phase 3 ARANOTE trial.

Data from a subgroup analysis of ARANOTE presented during the 

 demonstrated that patients with high-volume disease who received Nubeqa (315 patients) achieved a median radiological progression-free survival (rPFS) of 30.2 months compared with 19.2 months among those who received placebo (157 patients). Patients with low-volume disease achieved a median rPFS of not reached (NR) in the investigational arm (131 patients) versus NR in the control arm (66 patients).

“The phase 3 ARASENS study demonstrated a greater than 30% reduction in the risk of death with the combination of [Nubeqa] plus ADT and docetaxel, which has become a standard of care for the treatment of patients with mHSPC,” Dr. Fred Saad said during a presentation of the data. “In ARANOTE, [Nubeqa] plus ADT significantly improved rPFS, reducing the risk of radiological progression or death by 46%. Volume of disease is a prognostic factor for patients with mHSPC and here we report a post-hoc analysis of ARANOTE to evaluate the efficacy and safety of [Nubeqa] by disease volume.”

Saad is the director of prostate cancer research at the Montreal Cancer Institute, a uro-oncologist in the Urology Department, and a full professor in the Department of Surgery at the Centre Hospitalier de l'Université de Montréal in Canada.

In November 2024, the FDA accepted a supplemental new drug application (sNDA) seeking the approval of Nubeqa plus ADT for the treatment of patients with mHSPC. The sNDA was supported by previous data from ARANOTE. Findings from ARANOTE presented during the 2024 ESMO Congress showed that regardless of disease volume patients who received Nubeqa plus ADT (446 patients) achieved a median rPFS of NR versus 25 months in the placebo arm (223 patients).

Diving Into the ARANOTE Trial and Baseline Characteristics

ARANOTE was a global, double-blind study that enrolled patients with mHSPC who had an ECOG performance status of 0 to 2. Patients were stratified based on the presence of visceral metastases (yes versus no) and receipt of prior local therapy (yes versus no). Eligible patients were randomly assigned 2:1 to receive Nubeqa at a dose of 600 milligrams twice daily or placebo, both in combination with ADT.

The primary end point was rPFS by central blinded review. Secondary end points included overall survival (OS), time to initiation of subsequent anticancer therapy, time to metastatic castration-resistant prostate cancer (mCRPC), time to prostate-specific antigen (PSA) progression, rates of undetectable PSA (less than 0.2 ng/mL), time to pain progression and safety.

In the post-hoc analysis that Saad presented, patients were evaluated based on disease volume per CHAARTED criteria. High-volume disease was defined as the presence of visceral metastases and/or at least four bone lesions with at least one lesion beyond the vertebral bodies and pelvis. Low-volume disease was defined as not meeting the high-volume criteria.

At baseline, the median age of the overall patient population was 70 years. Most patients had a Gleason score of at least 8 at initial diagnosis (68.3%) and de novo metastasis at initial diagnosis (72.5%). The study also included patients with visceral metastases (12%), those who had received prior local therapy (17.9%), and those with an ECOG performance status of 0 (49.8%). The median serum PSA level at baseline was 21.3 ng/mL.

Further Efficacy and Safety Data from the Analysis

Additional findings from the post-hoc analysis showed that patients in the high- and low-volume groups experienced a delayed time to mCRPC with Nubeqa plus ADT versus placebo plus ADT, which was consistent with the benefit observed in the overall population. Patients with high-volume disease in the investigational and control arms achieved a median time to mCRPC of NR versus 12.4 months, respectively. In the low-volume group, the median time to mCRPC was NR versus 19.8 months, respectively.

The addition of Nubeqa to ADT also led to a benefit compared with placebo plus ADT across all secondary end points examined. The greatest benefits were reported in time to initiation of subsequent systemic anticancer therapy in patients with low-volume disease, time to PSA progression in patients with low-volume disease and time to PSA progression in patients with high-volume disease.

“OS results were immature, but suggestive of a benefit with [Nubeqa] versus placebo,” Saad noted.

Evaluable patients with high-volume disease in the Nubeqa arm (304 patients) had undetectable PSA levels 24, 36 and 48 weeks after random assignment at rates of 44%, 48% and 50%, respectively; 55% of these patients achieved undetectable PSA at any time. Comparatively, patients in the placebo arm (148 patients) achieved undetectable PSA at rates of 11%, 13%, 14% and 16%, at the respective time points.

Patients with low-volume disease who received Nubeqa (121 patients) also experienced undetectable PSA levels at higher rates compared with those who received placebo (63 patients) at the 24- (72% versus 17%, respectively), 36- (78% versus 19%) and 48-week (79% versus 19%) time points. Patients experienced undetectable PSA at any time at rates of 83% versus 25%, respectively.

In terms of safety, patients with high-volume disease who received Nubeqa (314 patients) or placebo (156 patients) both experienced any-grade treatment-emergent side effects (TEAEs; 93% versus 91.7%, respectively), grade 3 (severe) or 4 (life-threatening) TEAEs (31.2% versus 31.2%), serious TEAEs (28.3% versus 25.6%) and TEAEs leading to study drug discontinuation (7.3% versus 8.3%). Patients with low-volume disease in the Nubeqa (131 patients) and placebo (65 patients) arms also experienced any-grade TEAEs (86.3% versus 86.2%), grade 3 or 4 TEAEs (29.8% versus 26.2%), serious TEAEs (12.2% versus 18.5%) and TEAEs leading to study drug discontinuation (3.1% versus 10.8%).

“Efficacy outcomes with [Nubeqa] plus ADT were improved versus placebo plus ADT regardless of disease volume,” Saad said in conclusion. “[Nubeqa] plus ADT was well tolerated in both high-volume and low-volume subgroups with low treatment discontinuation rates consistent with the overall population and reconfirming the established tolerability of darolutamide. Patients with low-volume mHSPC had marked treatment efficacy with minimal treatment burden.”

“Darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC) by disease volume: subgroup analysis of the phase 3 ARANOTE trial.” By Dr. Fred Saad, et al. 

“Efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase III ARANOTE trial.” By Dr. Fred Saad, et al. 

Nubeqa (darolutamide) combined with androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to placebo plus ADT, regardless of disease volume. The ARANOTE trial demonstrated a 46% reduction in the risk of radiological progression or death. High-volume disease patients achieved a median rPFS of 30.2 months, while low-volume disease patients' rPFS was not reached. Nubeqa plus ADT was well tolerated, with low treatment discontinuation rates, confirming its established safety profile.

Nubeqa plus ADT improved rPFS in mHSPC regardless of disease volume, reducing the risk of radiological progression or death by 46%, per ARANOTE data.

Canonical

Nubeqa Plus ADT Effective in mHSPC Regardless of Disease Volume

Among patients with prostate cancer, treatment with carbon ion radiation therapy (CIRT) was found to result in a temporary decline in urinary function immediately after treatment. However, after three months, urinary function returned to normal, and recovery was sustained up to five years afterwards.

Research from a prospective study was presented in a poster at the 

“Following CIRT treatment, the voiding parameters in patients [with prostate cancer] significantly deteriorated immediately,” first author Dr. Yoshiyuki Miyazawa and colleagues said in a poster presentation of the study’s fundings at the symposium. “However, after three months, they returned to their pre-treatment levels and remained stable for five years. Without [androgen deprivation therapy (ADT)], the prostate volume reduced [by minus] 20% after two years and remained reduced for five years.”

Miyazawa is an assistant professor with the Department of Urology, Gunma University Graduate School of Medicine, in Gunma, Japan.

Researchers enrolled 309 patients with localized prostate cancer who were classified as T1-T3N0M0 onto the trial. The median age of eligible patients was 66.5 years, and patients underwent CIRT between 2010 and 2013. Of these eligible participants, patients with T1c-T2bN0M0, an initial prostate-specific antigen (PSA) of less than 10 ng/ml and a Gleason score of 6 or less were classified as the low-risk group (16 patients), with none receiving ADT. Patients with at least T3, an initial PSA of 20 ng/ml or greater or a Gleason Score of at least 8 were categorized as the high-risk group (146 patients), with six months of neoadjuvant ADT and 1.5 years of adjuvant ADT. Any patients falling outside of these parameters were classified into the intermediate-risk group (142 patients), with six months of neoadjuvant ADT, according to the poster presentation.

Patients’ maximum flow rate was found to significantly worsen at one month post-treatment compared with pre-treatment levels, but returned to pre-treatment levels by three months post-treatment. Researchers reported flow rates of 20.0 ± 10.6 ml/s pre-treatment, 14.5 ± 7.3 ml/s, post-treatment, and 18.7 ± 8.9 ml/s three months after treatment. The mean flow rate was found to have significantly worsened one month after treatment but was shown to return to pre-treatment levels by three months later, and was maintained for up to five years, with rates of 8.3 ± 4.0 ml/s pre-treatment, 6.0 ± 3.2 ml/s post-treatment, 7.7 ± 4.3 ml/s at three months, and 10.5 ± 4.9 ml/s at 3 years.

Prostate volume in cases without ADT was found to significantly decrease one year after treatment and reached approximately 80% of initial volume by three years and remained stable up to five years, researchers reported in the poster, also noting that multivariate analysis identified T classification and prostate volume as significant predictive factors for late genitourinary tract complications.

The 5-year PSA biochemical non-recurrence rate was 92.7%, researchers noted in 

, explaining that results broken down by risk criteria were 91.7% for low-risk cases, 93.4% for intermediate-risk cases, and 92% for high-risk cases, while the overall survival rate during the follow-up period was 96.6%.

“The long-term prospective study conducted over five years has elucidated the changes in urinary function and prostate volume in patients with prostate cancer following CIRT. Based on these data, it was suggested that complications in CIRT patients might be predictable through pre-treatment evaluations,” Miyazawa and authors concluded in the abstract of the poster presentation.

“Analysis of urinary function and prostate volume changes in localized prostate cancer patients treated with carbon-ion radiotherapy; a prospective study.” By Dr. Yoshiyuki Miyazawa, 

2. “Analysis of urinary function and prostate volume changes in localized prostate cancer patients treated with carbon-ion radiotherapy; a prospective study.” By Dr. Yoshiyuki Miyazawa, 

Carbon ion radiation therapy (CIRT) in prostate cancer patients initially causes a decline in urinary function, which normalizes within three months and remains stable for five years. A study involving 309 patients revealed that prostate volume decreased significantly without androgen deprivation therapy (ADT) and remained reduced. The study identified T classification and prostate volume as predictors for late genitourinary complications. The five-year PSA biochemical non-recurrence rate was 92.7%, with an overall survival rate of 96.6%. These findings suggest that pre-treatment evaluations can predict CIRT complications.

Although carbon ion radiation led to a decline in urinary function among patients with prostate cancer, function returned to normal after three months. 

Patients With Prostate Cancer Experience Temporary Urinary Function Decline After CIRT

Among patients with intermediate-risk prostate cancer, high prostate-specific antigen (PSA) levels before treatment with a High-Intensity Focused Ultrasound (HIFU) had a link to an increased risk of overall recurrence and treatment failure, according to research published in a poster at the 

2025 ASCO Genitourinary Cancers Symposium.

In this investigation of 108 men with intermediate-risk prostate cancer following HIFU, investigators found that in-field and overall recurrence on 1-year biopsy was 41% and 54%, respectively. Moreover, Gleason grade (GG) 3 or higher was associated with both in-field and overall recurrence on biopsy, while sexual and urinary function scores did not vary before vs after HIFU.

“Higher pre-HIFU PSA was associated with treatment failure and overall recurrence on biopsy, and GG3 [or higher] was associated with in-field and overall recurrence on biopsy, first study author Dr. Kevin Shee, and authors wrote in the abstract of the study.

Shee currently works in the Department of Urology, University of California, San Francisco (UCSF), UCSF Health, and is a Resident of Urology at the UCSF School of Medicine.

Breaking Down the Methods of the Research

Definitive therapy and active surveillance are both common ways to manage intermediate-risk prostate cancer. Although definitive treatments, such as radical prostatectomy or radiation therapy, are effective, they are often associated with significant side effects. For patients with favorable-risk disease, active surveillance may be an option, but this approach carries the risk of cancer progression over time.

Focal therapies selectively ablate cancerous tissue while minimizing the impact on quality of life, providing a more balanced approach. One such therapy is High-Intensity Focused Ultrasound (HIFU), which utilizes magnetic resonance imaging (MRI) and ultrasound to deliver high-frequency acoustic energy. Despite the potential benefits of HIFU, concerns regarding disease recurrence and progression to salvage treatment have limited its widespread adoption. To address investigators investigated pre-treatment characteristics associated with treatment progression and biopsy-confirmed recurrence following HIFU.

High pre-treatment PSA levels in intermediate-risk prostate cancer patients undergoing HIFU are linked to increased recurrence and treatment failure. A study of 108 men revealed that 41% experienced in-field recurrence, while 54% had overall recurrence within a year. Gleason grade 3 or higher was associated with recurrence, but sexual and urinary functions remained stable post-treatment. The study highlights the importance of patient selection for HIFU, which offers modest cancer control with minimal side effects for suitable candidates.

Among those with intermediate-risk prostate cancer, high PSA levels prior to HIFU led to an increased risk of overall recurrence and treatment failure.

Dr. Rachna Shroff

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