All studies
Active not recruitingPHASE3INTERVENTIONAL

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

This research is looking into a new treatment called 177Lu-PSMA-617 for men with advanced prostate cancer that has spread and isn't responding to initial hormone therapy. This type of cancer is known as metastatic castrate-resistant prostate cancer (mCRPC). The study wants to find out if 177Lu-PSMA-617 is better than simply changing to a different type of standard hormone therapy. They are comparing how long people live, and how long the cancer is kept under control without growing. Participants previously received one type of hormone therapy and have not had certain chemotherapy treatments. The study has already given treatment to 469 men in a way that randomly assigned them to receive either the new treatment or a different hormone therapy.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Novartis Pharmaceuticals
Enrolment target
469
Start
15 Jun 2021
Estimated completion
30 Sep 2026

What is this study about?

This study is a research project designed to explore a new treatment option for men with a specific type of prostate cancer. This is prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to standard hormone therapy (castrate-resistant). The main goal of the study is to see if a new treatment called 177Lu-PSMA-617 is more effective than switching to a different type of hormone therapy that targets the cancer's growth.

The researchers want to know two main things: first, if 177Lu-PSMA-617 can stop the cancer from growing or spreading for a longer period of time (this is called 'radiographic progression-free survival'). Second, they want to find out if this new treatment helps people live longer overall. The study is very carefully designed with a large number of participants to give reliable answers. They will follow participants for over three years to gather all the necessary information.

It's important to understand that this study is for men who have already tried one type of hormone therapy and whose cancer has started to grow despite that. They also haven't had a specific type of chemotherapy (taxane-containing regimen) for their advanced prostate cancer. By comparing the new treatment to an existing approach, scientists hope to find better ways to help people living with this challenging condition.

Key takeaways

  • This study compares a new treatment (177Lu-PSMA-617) for advanced prostate cancer to a different standard hormone therapy.
  • It's for men whose prostate cancer has spread and is no longer responding to their current hormone treatment.
  • The main goals are to see if the new treatment slows cancer growth or helps people live longer.
  • You would be randomly assigned to one of the two treatment groups.
  • Participants must have specific markers on their cancer cells.
  • The study lasts for over three years.

Who may be eligible?

To be considered for this study, you would typically need to be an adult male, at least 18 years old, and have prostate cancer that has been confirmed by a doctor.

Your prostate cancer must have spread to other parts of your body and needs to have stopped responding to your current hormone therapy. You would also need to have only tried one type of advanced hormone therapy (like abiraterone or enzalutamide) before. Importantly, you shouldn't have received certain strong chemotherapy treatments for your advanced prostate cancer. Your general health should be good enough to participate, as assessed by the research team.

Before formally joining, you would have a special scan to check if your cancer cells show a particular marker called PSMA, which is necessary for the new treatment to work. Only those with enough of this marker will be able to join the study.

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.

  1. Are you an adult male with prostate cancer?
  2. Has your prostate cancer spread?
  3. Is your prostate cancer no longer responding to your current hormone therapy?
  4. Have you used only one type of advanced hormone therapy before?
  5. Have you NOT received certain strong chemotherapy treatments for your advanced prostate cancer?
  6. Are you fit enough to participate in a clinical trial?
Answer every question to see your result.

What does participation involve?

If you join this study, the first step is a 'screening period'. During this time, you'll have tests, including a special scan called a 68Ga-PSMA-11 PET/CT, to confirm your cancer has the right markers and that you meet all other health requirements. If you are eligible, you'll then be randomly assigned to one of two groups, like flipping a coin. You'll either receive the new treatment, 177Lu-PSMA-617, or a different standard hormone therapy (either abiraterone or enzalutamide).

The treatments will be given over a period of time, and you'll have regular check-ups and tests. This will allow the doctors to see how well the treatment is working and monitor for any side effects. The study is planned to last for about 43 months, which is just over three and a half years. During this time, researchers will closely track your cancer progression and overall health, using scans and other medical assessments. You will also be allowed to receive other supportive care as needed.

Potential risks and benefits

Participating in a study means you might receive a new treatment that could potentially be more effective than current options, possibly slowing down your cancer's growth or helping you live longer. However, there's always a chance the new treatment might not work as well, or as expected. All treatments, both new and standard, come with potential side effects, and some might be serious. The research team will carefully monitor your health for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (72)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Rocky Mountain Cancer Centers
    Verified postcode
    Denver, United States
  • University of Florida
    Verified postcode
    Gainesville, United States
  • Tulane Uni Health Sciences Center
    Verified postcode
    New Orleans, United States
  • Dana Farber Cancer Institute
    Verified postcode
    Boston, United States
  • Beth Israel Deaconess Med Ctr
    Verified postcode
    Boston, United States
  • WA Uni School Of Med
    Verified postcode
    St Louis, United States
  • Urology Cancer Center PC
    Verified postcode
    Omaha, United States
  • Nebraska Cancer Specialists
    Verified postcode
    Omaha, United States
  • NYU Laura and Isaac Perlmutter Cancer Center
    Verified postcode
    New York, United States
  • Mount Sinai Hosp Med School
    Verified postcode
    New York, United States
  • Memorial Sloan Kettering Cancer Ctr
    Verified postcode
    New York, United States
  • Duke Univ Medical Center
    Verified postcode
    Durham, United States

Common questions

What is metastatic castrate-resistant prostate cancer?

This is prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to standard hormone treatments (castrate-resistant).

What is 177Lu-PSMA-617?

It's a new type of treatment being tested that targets specific markers on prostate cancer cells to deliver radiation directly to them.

Will I definitely get the new treatment if I join?

No, you will be randomly assigned to either receive the new treatment or a different standard hormone therapy. It's like drawing lots.

How long will I be involved in the study?

The study aims to follow participants for approximately 43 months, which is just over three and a half years.

Do I have to pay to be in the study?

No, clinical trials usually cover the cost of the study treatments and related tests. You should check with the study team if there are any other potential costs.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.