STAND TALL IN YOUR FIGHT AGAINST
PROSTATE CANCER
Join our study of an investigational new oral treatment which may help hormone inhibitor therapy work more effectively.
About the Himalayas-1 Clinical Study
The Himalayas-1 Clinical Study is exploring if an investigational new oral treatment combined with hormone inhibitor therapy can help slow down or prevent prostate cancer from getting worse compared to other standard treatments.
The investigational treatment rinzimetostat will be taken as tablets by mouth once a day. It is designed to block a process in prostate cancer cells that helps the cancer grow and resist current hormone inhibitor treatments. By stopping this process, rinzimetostat may help certain prostate cancer hormone inhibitor treatments (like darolutamide) to work again or to work better and could slow down the cancer or stop it from getting worse. Clinical research to date has shown that rinzimetostat may be helpful when used together with darolutamide.
SEE IF YOU QUALIFYWhy join the Himalayas-1 Clinical Study?
If you qualify, you may receive at no cost:
- Access to the investigational new oral treatment (rinzimetostat) in combination with hormone inhibitor therapy (darolutamide), or another therapy frequently used in the treatment of prostate cancer
- Study-related medical care and follow-up throughout the study
- Reimbursement for reasonable study-related expenses as allowed by local regulations
You may be eligible to join if you:
- Are male (18 years or older)
- Have been diagnosed with metastatic castration-resistant prostate cancer (mCRPC)
- Are willing to continue hormone suppression therapy that keeps testosterone low during the study, or have had both testes removed
- Have taken abiraterone acetate for at least 12 weeks and have proof that your cancer got worse during or soon after treatment
- Have had up to one course of chemotherapy, but must not have received chemotherapy since the cancer became castration-resistant
There are additional requirements you must meet to join the Himalayas-1 Clinical Study, connect with a study center to learn more.
After screening (assessments to see if the study is right for you), participants are randomly selected (like the flip of a coin) to join 1 of 2 treatment groups:
The investigational treatment (rinzimetostat) will be taken as tablets by mouth once daily in combination with darolutamide taken as tablets by mouth twice daily
A different form of hormone inhibitor therapy (enzalutamide or darolutamide) will be taken by mouth once or twice daily, or chemotherapy for prostate cancer (docetaxel) given as an intravenous infusion once every 3 weeks (to be decided by a physician) for up to 10 doses
There is a 50% chance that you will be assigned to 1 of 2 treatment groups. Three of the drugs used in the study (darolutamide, enzalutamide, and docetaxel) are frequently used in the treatment of prostate cancer. The treatments are given over 21- or 28-day cycles.
How long is the Himalayas-1 Clinical Study?
Taking part in the Himalayas-1 Clinical Study includes the following:
Screening: Up to 28 days to check if you are eligible
Treatment period: Ongoing as long as treatment is tolerated and/or your cancer does not get worse or progress on radiographic scans
Safety follow-up: 28 days after the last dose to check on your health
Long-term follow-up: Every 12 weeks to check on your health and future treatmentsFind a study center
Please select the study center that is most convenient for you.
About mCRPC
Many men with prostate cancer respond well to testosterone lowering and hormone inhibitor treatments at first, but over time, the cancer can learn to grow even without testosterone.
When this happens, the prostate cancer can not only return but also spread outside the prostate gland. This is called metastatic castration-resistant prostate cancer (mCRPC). With mCRPC, the prostate cancer becomes resistant to testosterone-lowering therapy.
Cancer at this stage often adapts to overcome current treatments, so research studies like the Himalayas-1 Clinical Study aim to explore new treatment options to improve care for men with mCRPC.
A clinical research study (also called a clinical trial) is carefully supervised research that is done before an investigational drug becomes available to the public.
- Clinical studies follow specific rules to protect the safety, rights, well-being, and privacy of participants.
- The results help doctors and researchers decide if a medication or product is safe and should be made available to patients.
- Clinical studies are the only way to develop new medical treatments to improve patient care.
Frequently asked questions
Rinzimetostat is an investigational new oral treatment that comes as a tablet you take by mouth once a day. It is designed to block a process in prostate cancer cells that helps the cancer grow and resist current hormone treatments. By stopping this process, rinzimetostat may help certain prostate cancer hormone inhibitor treatments, like darolutamide, work again or work better and could slow down the cancer or stop it from getting worse. Clinical studies to date have shown that rinzimetostat may be helpful when used together with darolutamide.
Taking part in the Himalayas-1 Clinical Study includes the following:
- Screening: Up to 28 days to check if you are eligible
- Treatment period: Ongoing as long as treatment is tolerated and/or your cancer does not get worse or progress on radiographic scans
- Safety follow-up: 28 days after the last dose to check on your health
- Long-term follow-up: Every 12 weeks to check on your health and future treatments.
Participants are allowed to join the Himalayas-1 Clinical Study if they have received abiraterone acetate for at least 12 weeks. Participants also may have received chemotherapy for metastatic castration-sensitive prostate cancer, as long as there was no progression (worsening or spread) of the cancer during or within 3 months after treatment.
During a clinical study, you’ll receive the treatment that is being studied, or another therapy frequently used in the treatment of prostate cancer. This will be done at scheduled times throughout the study, with the exact schedule depending on the treatment. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams, or other types of assessments that are necessary to gather the required information about the study treatment. All study participants are always closely monitored by clinic staff and the medical team to help ensure their safety.
Participation in any clinical study is completely voluntary. Your decision to participate—or not participate—in this clinical study will have no effect on the medical care that you receive now or in the future.
Depending on local regulations, participants may receive reimbursement for reasonable study-related expenses. For more information, please speak with a member of the study team during your study visits.
There are many reasons to participate in clinical research. For starters, it allows participants to play a more proactive role in their own health by potentially receiving a new investigational treatment for an ongoing disease or condition. Participants also play an important part in bringing much-needed drugs to market, benefiting thousands of people who also have the disease or condition. In many cases, this can be life changing.
Every clinical study must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant.
ORIC Pharmaceuticals, Inc. is responsible for conducting the Himalayas-1 Clinical Study.
