RecruitingPHASE3INTERVENTIONAL

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

This study is for men with prostate cancer that has spread to a few places in the body, but not widely. This is called oligometastatic prostate cancer. Even after initial treatments, the cancer has started to show signs of returning. The study is testing a new treatment called AAA617 (lutetium (177Lu) vipivotide tetraxetan). Some men will receive AAA617, and others will be carefully watched. Doctors want to see if AAA617 can stop the cancer from getting worse and delay the need for other treatments like hormone therapy, which can have side effects. The main goal is to find out if this new treatment is safe and effective in controlling the cancer and improving quality of life for men in the early stages of advanced prostate cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

450

Start

12 Mar 2024

Estimated completion

03 Oct 2031

Oligometastatic Prostate Cancer (OMPC)

What is this study about?

This study is exploring a new way to treat prostate cancer that has spread to a few small areas in the body, often called 'oligometastatic'. This means the cancer isn't widely spread, but it's no longer just in the prostate gland. For men in this situation, their initial treatments, such as surgery or radiotherapy, didn't completely get rid of the cancer, and it's now showing signs of coming back.

The new treatment being tested is called AAA617. It's a type of radiation therapy that targets specific prostate cancer cells. The idea is that by targeting these few cancer spots early, doctors might be able to stop the cancer from progressing further and becoming more advanced. This study wants to see if AAA617 is better than just 'watching and waiting' — keeping a close eye on the cancer without immediate active treatment with AAA617.

The main aim is to find out if AAA617 can effectively control the cancer's growth and delay the need for other treatments like hormone therapy (androgen deprivation therapy or ADT). Hormone therapy can have side effects, so delaying it could help men maintain a good quality of life for longer. The study will also carefully check if AAA617 is safe for patients.

Key takeaways

This study is for men with early-stage spread (oligometastatic) prostate cancer.
It tests a new targeted radiation treatment (AAA617) against careful watching.
All participants will receive initial targeted radiation to their cancer spots.
The goal is to stop cancer growth and delay other treatments like hormone therapy.
The study involves regular check-ups and scans for several years.
It aims to improve quality of life by controlling cancer early.

Who may be eligible?

This study is looking for men aged 18 to 100 who have prostate cancer.

Your prostate cancer must have returned after you've had surgery or radiation to treat it previously. We'll know it's returned if your PSA levels (a blood test for prostate cancer) have gone up. Important: to join, scans must show you have between 1 and 5 small areas of prostate cancer spread, and these spots must light up on a special type of scan called a PSMA PET/CT scan. At least one of these spots needs to be outside the prostate area.

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 to 100?
Has your prostate cancer come back after previous treatment like surgery or radiation?
Do you have between 1 and 5 small areas of cancer spread visible on a special PSMA PET/CT scan?
Is at least one of these spots outside the prostate area?
Have you not started any new hormone therapy for your cancer recently?

Answer every question to see your result.

What does participation involve?

If you join this study, everyone will first have special scans, including a PSMA PET/CT scan, to map out the cancer. All men in the study will then have targeted radiation (called SBRT) to treat all the small areas where the cancer has spread. This radiation treatment takes about 3 weeks.

After this, you'll be randomly put into one of two groups: one group will receive the new treatment, AAA617, for up to 4 cycles (each cycle includes treatment and recovery time). The other group will be carefully watched. You'll have regular check-ups, typically every week for the first few weeks of a cycle, then every 16 weeks after that, to see how you're doing and if the cancer has progressed. The study is quite long, lasting for about 6 and a half years in total.

Potential risks and benefits

Taking part in this study could potentially help control your prostate cancer and delay other treatments, which might improve your quality of life. However, there are always potential risks with new treatments, including side effects from the targeted radiation (AAA617) or the SBRT. The study team will carefully monitor you for any problems. Remember, you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (147)

Highlands Oncology Group
Verified postcode
Fayetteville, United States· Recruiting
VA Greater LA Healthcare System
Verified postcode
Los Angeles, United States· Recruiting
VA Palo Alto Health Care System
Verified postcode
Palo Alto, United States· Recruiting
Stanford University
Verified postcode
Palo Alto, United States· Recruiting
UCSF
Verified postcode
San Francisco, United States· Recruiting
Rocky Mountain Cancer Centers
Verified postcode
Denver, United States· Recruiting
Cancer Specialists of North Florida
Verified postcode
Jacksonville, United States· Recruiting
Woodlands Medical Specialists
Verified postcode
Pensacola, United States· Recruiting
Piedmont Healthcare
Verified postcode
Atlanta, United States· Recruiting
University of Chicago
Verified postcode
Chicago, United States· Recruiting
The Cancer Institute of Alexian Brothers
Verified postcode
Elk Grove, United States· Recruiting
Unity Point Clinic
Verified postcode
Des Moines, United States· Recruiting

Common questions

What does 'oligometastatic prostate cancer' mean?

It means your prostate cancer has spread to a few small areas in your body, but not widely.

What is AAA617?

AAA617 is an experimental radiation treatment that targets specific prostate cancer cells where the cancer has spread.

Will I definitely get the new treatment?

No, participants are randomly assigned to either receive AAA617 or be carefully watched. Everyone gets initial targeted radiation (SBRT).

How long will I be in the study?

The study itself lasts about 6 and a half years, but your active participation might vary depending on your group and if your cancer progresses.

What is a PSMA PET/CT scan?

It's a special scan that helps doctors find prostate cancer cells that have spread, even if they are very small.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

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