Active not recruitingPHASE2INTERVENTIONAL

177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer

This clinical trial is looking for men with advanced prostate cancer that has spread to other parts of the body and is no longer responding to usual hormone treatments. The study is comparing a new type of treatment, called 177Lu-PSMA-617, with a standard chemotherapy drug, docetaxel. 177Lu-PSMA-617 works by delivering radiation directly to cancer cells. Researchers want to find out if this new treatment can slow down the growth of prostate cancer more effectively than the standard chemotherapy. This is important because it could offer a new and better way to manage this type of prostate cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Canadian Cancer Trials Group

Enrolment target

200

Start

11 Aug 2021

Estimated completion

31 Dec 2026

Prostate Cancer

What is this study about?

This study is for men with prostate cancer that has spread in the body (called metastatic) and has stopped responding to hormone treatments (called castration-resistant). When this happens, doctors sometimes offer chemotherapy, a type of medicine that kills cancer cells. One common chemotherapy is called docetaxel.

Now, there's a new treatment being investigated called 177Lu-PSMA-617. This treatment is special because it's designed to find and attach to specific markers on prostate cancer cells. Think of it like a guided missile that delivers radiation directly to the cancer cells, aiming to destroy them while causing less harm to healthy cells around them. Doctors want to see if this targeted approach is better at controlling the cancer than the standard chemotherapy.

The main goal of this trial is to directly compare how well 177Lu-PSMA-617 works compared to docetaxel. Both treatments aim to slow down the cancer's growth. By doing this comparison, researchers hope to discover if the new treatment offers a more effective way for men with this type of prostate cancer to manage their condition.

Key takeaways

This study compares a new targeted radiation treatment for prostate cancer with standard chemotherapy.
It's for men with advanced prostate cancer that has spread and no longer responds to hormone therapy.
The new treatment, 177Lu-PSMA-617, aims to deliver radiation directly to cancer cells.
Participants will be randomly assigned to receive either the new treatment or docetaxel chemotherapy.
The goal is to see if the new treatment is better at slowing cancer growth.
Your suitability will be checked by medical scans and tests.

Who may be eligible?

This study is for adult men, aged 18 or older, who have prostate cancer that has spread beyond the prostate (metastatic) and is no longer controlled by hormone treatments. Your cancer must also show a specific marker called PSMA, which can be seen on special scans.

You would not be able to join if you have received chemotherapy for this advanced stage of prostate cancer before, or if you had chemotherapy for earlier prostate cancer within the last year. Also, if you have been treated with 177Lu-PSMA or similar radiation therapies in the past, or if certain types of cancer have spread to your brain, this study would not be suitable for you. Your general health and how well your organs are working will also be checked.

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 an adult man (18 years or older) with prostate cancer?
Has your prostate cancer spread to other parts of your body?
Is your prostate cancer no longer responding to hormone treatments?
Have you NOT had chemotherapy for advanced prostate cancer before?
Do special scans show that your cancer has a marker called PSMA?
Are your general health and organ functions good enough for a clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive the new treatment, 177Lu-PSMA-617, or the standard chemotherapy drug, docetaxel. Both are given as injections, either into a vein or directly into the cancer area, and will be given over several weeks or months. You will have regular appointments at the hospital for these treatments, and also for blood tests, scans (like CT or bone scans), and physical exams to see how you are responding and if you're experiencing any side effects. You will be closely monitored throughout the treatment period and for some time after your last dose, which will involve follow-up visits.

Potential risks and benefits

Taking part might offer the potential benefit of a new treatment that could be more effective or have different side effects than standard chemotherapy. However, all medical treatments carry risks, and the new treatment could have unknown side effects. Your care team will explain all known potential side effects of both treatments. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Tom Baker Cancer Centre
Verified postcode
Calgary, Canada
Cross Cancer Institute
Verified postcode
Edmonton, Canada
BCCA - Vancouver Cancer Centre
Verified postcode
Vancouver, Canada
London Regional Cancer Program
Verified postcode
London, Canada
Odette Cancer Centre
Verified postcode
Toronto, Canada
University Health Network
Verified postcode
Toronto, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Verified postcode
Montreal, Canada
The Jewish General Hospital
Verified postcode
Montreal, Canada
Hotel-Dieu de Quebec
Verified postcode
Québec, Canada
CIUSSS de l'Estrie - Centre hospitalier
Verified postcode
Sherbrooke, Canada

Common questions

What is advanced prostate cancer?

This means your prostate cancer has spread to other parts of your body, and it's no longer responding to standard hormone treatments.

What is 177Lu-PSMA-617?

It's a new type of treatment that uses a mild radioactive substance to find and target prostate cancer cells, aiming to destroy them.

What is docetaxel?

Docetaxel is a common chemotherapy drug used to treat many types of cancer, including advanced prostate cancer.

Will I get to choose which treatment I receive?

No, in this type of study, participants are randomly assigned to receive either the new treatment or the standard treatment, like flipping a coin.

How long will the study last if I join?

The study involves regular treatments over several months, followed by close monitoring, but the exact duration will be discussed with you by the research team.