RecruitingPHASE1, PHASE2INTERVENTIONAL

Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer

This research study, called ASpiRE, is investigating a new treatment approach for men with a type of prostate cancer called metastatic castration-resistant prostate cancer (mCRPC). This means the cancer has spread to other parts of the body and is no longer being controlled by common hormone treatments. The study is testing a drug called SX-682 alongside an existing medicine called Apalutamide. Researchers want to find out if combining these two drugs is safe and whether it can help to better manage the cancer. It's a key step in finding new ways to help people with this condition and offers the chance to contribute to medical knowledge that could benefit others in the future.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

28 Apr 2025

Estimated completion

01 Oct 2029

Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

What is this study about?

This study is about exploring a new way to treat prostate cancer that has spread to other parts of the body and has become resistant to standard hormone treatments. This type of cancer is called metastatic castration-resistant prostate cancer, or mCRPC for short. When prostate cancer is resistant to hormone treatment, it means that the usual medicines used to lower male hormones (like testosterone) are no longer working as well to control the cancer’s growth.

The study is investigating a new drug called SX-682, which will be given together with an already approved medicine called Apalutamide. Apalutamide is a type of hormone therapy that works differently from older hormone treatments. By combining these two drugs, researchers hope to find out if this new combination can be more effective at slowing down the cancer's growth and spread than current treatments alone. This is an early-stage study, meaning it's one of the first times this combination is being tested in people. The main goals are to check if it's safe and to see if it shows promise in treating mCRPC.

Taking part in a study like this helps doctors learn more about diseases and find better treatments. While it might not directly benefit everyone who participates, your involvement is very important for advancing medical understanding and improving care for future patients. We understand that participating in a clinical trial can be a big decision, and our team will be there to support you and answer any questions you have.

Key takeaways

Tests a new combination of drugs, SX-682 and Apalutamide, for advanced prostate cancer.
For men whose prostate cancer has spread and is resistant to typical hormone therapy.
Aims to check safety and see if the new combination can better control the cancer.
Involves regular hospital visits, blood tests, scans, and possibly biopsies.
Your participation helps doctors learn and improve future treatments for prostate cancer.

Who may be eligible?

This study is for men aged 18 or older who have prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone therapy. You will need to have had at least one previous treatment with a newer type of hormone therapy (like enzalutamide, Apalutamide, or darolutamide) for at least 12 weeks, and your cancer must have shown signs of getting worse after this treatment.

Important requirements include having a confirmed diagnosis of prostate cancer with tissue available for researchers to look at, or being willing to have a new biopsy. For some parts of the study, you'll need to agree to have biopsies before and during treatment. Your general health will also be assessed to make sure you're well enough to take part, and you must be able to swallow the study medication. You'll also need to be using effective contraception during the study and for 6 months after your last dose, as the study drugs might affect unborn babies.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged 18 or older?
Do you have prostate cancer that has spread?
Has your prostate cancer gotten worse after at least 12 weeks of a newer hormone therapy (like enzalutamide, Apalutamide, or darolutamide)?
Are you able and willing to follow the study's treatment schedule and attend appointments?
Are you willing to use effective contraception during the study and for 6 months afterwards?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given two different medications: SX-682 and Apalutamide. You will take these medicines as directed by the study team. You will have regular visits to the hospital or clinic, which will include examinations, blood tests, and scans (like bone scans and other imaging tests) to monitor your health and how the treatment is working. Some participants may also need to have biopsies (small tissue samples taken) before and during the treatment period.

The study will involve several appointments over time, and the research team will explain the schedule to you in detail. The total duration of your participation will depend on how you respond to the treatment and the stage of the study you are in. You will also have follow-up appointments after you stop taking the study medication. Throughout your participation, the study team will be there to answer your questions and support you.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. You might not directly benefit from this specific treatment, but the information gained from your participation could help other people with prostate cancer in the future. You will also receive careful medical monitoring throughout the study. Potential risks include side effects from the medications, which will be carefully explained to you by the study team. They will monitor you closely for any side effects and manage them as best as possible. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Oncology Institute of Southern Switzerland
Verified postcode
Bellinzona, Switzerland· Not yet recruiting
Belfast Health and Social Care Trust
Verified postcode
Belfast, United Kingdom· Recruiting
Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom· Recruiting
The Royal Marsden NHS Foundation Trust - Drug Development Unit
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is 'metastatic castration-resistant prostate cancer'?

It's prostate cancer that has spread to other parts of the body (metastatic) and is no longer being controlled by standard hormone treatments (castration-resistant).

What are SX-682 and Apalutamide?

Apalutamide is an existing hormone therapy that blocks male hormones. SX-682 is a new drug being tested alongside Apalutamide in this study to see if the combination works better.

Will I have to have biopsies?

Yes, if your cancer doesn't have existing tissue available; and for some parts of the study, you will need to agree to biopsies before and during treatment to help researchers understand the drugs' effects.

How long will I be in the study?

The length of time you participate will depend on how you respond to the treatment and the stage of the study, but you'll have regular check-ups and follow-up.

Can I stop participating at any time?

Yes, you are free to leave the study at any point, and it won't affect your future medical care.

How to find out more

Aasia Hussain, PhD

ASPIRE@icr.ac.uk 02034376301 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.