Estrogen + Androgen Receptor Inhibitor for Prostate Cancer

This trial aims to determine if adding estrogen to standard prostate cancer treatment can enhance the quality of life for men with hormone-sensitive prostate cancer that has spread. The study compares two treatment plans: one with estrogen patches (transdermal estrogen) and another with the usual hormone therapy. The goal is to reduce common side effects such as hot flashes and fatigue. Men with newly diagnosed or returning metastatic prostate cancer, who haven't undergone certain treatments, might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

The trial does not specify if you need to stop taking your current medications. However, you cannot have had prior therapy with certain prostate cancer treatments like LHRH analogues or next-generation androgen receptor-signaling inhibitors. It's best to discuss your current medications with the trial team.

Research has shown that using estrogen patches on the skin, along with drugs that block certain hormone signals, is generally safe for prostate cancer patients. Studies have found that estrogen patches do not increase the risk of heart problems compared to traditional treatments like LHRH analogues. Both methods yield similar results in controlling cancer spread and survival rates.

In a study involving 1,360 men, estrogen patches proved just as effective as other hormone treatments in preventing cancer spread. Long-term data also show no major differences in heart health between those using estrogen patches and those on standard treatments.

Another study with 20 men found that using estrogen patches for eight weeks reduced the number of hot flashes, a common side effect of hormone treatments for prostate cancer.

Unlike the standard treatments for prostate cancer, which often involve hormone therapies like LHRH agonists or antagonists, this new approach uses transdermal estrogen. This method delivers estrogen through a patch on the skin, which is thought to minimize some of the side effects associated with other hormone therapies. Additionally, the combination with an androgen receptor signaling inhibitor (ARSI) could target cancer cells more effectively by blocking the hormones that fuel the cancer's growth. Researchers are excited about the potential for this treatment to offer a more tolerable and effective option for patients, possibly reducing hot flashes and other side effects linked with traditional treatments.

This trial will compare two treatment approaches for advanced prostate cancer. In one arm, participants will receive estrogen via transdermal patches along with an androgen receptor signaling inhibitor (ARSI). Research has shown that using estrogen patches with certain medications can be promising for treating advanced prostate cancer. Studies have found that this combination works as well as standard hormone treatments. Patients using estrogen patches often experience a better quality of life, with less fatigue and fewer hot flashes. These patches also help maintain bone health and have less impact on sexual function. Early results suggest that this treatment controls cancer effectively, with patients reaching similar levels of PSA, a marker used to monitor prostate cancer.¹²⁵⁶⁷