Study Comparing 177Lu-PSMA-617 with Standard Treatment for Men with Metastatic Hormone-Sensitive Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as metastatic hormone-sensitive prostate cancer (mHSPC). The trial is investigating the effectiveness of a treatment called 177Lu-PSMA-617, which is used in combination with the standard care for this condition. The standard care may include various medications such as relugolix, goserelin acetate, triptorelin acetate, degarelix, bicalutamide, apalutamide, enzalutamide, darolutamide, abiraterone, flutamide, nilutamide, buserelin, histrelin, and leuprorelin. The purpose of the study is to evaluate how well the combination of 177Lu-PSMA-617 and standard care works compared to standard care alone in treating mHSPC.

Participants in the study will receive either the combination treatment or the standard care alone. The study will monitor the progress of the disease using imaging techniques to see if the cancer is spreading or staying the same. The trial will also look at overall survival, which means how long patients live after starting the treatment, and other health outcomes. The study will last for a period of time, and participants will be regularly checked to see how they are responding to the treatment.

This trial is important for understanding if adding 177Lu-PSMA-617 to the standard care can improve outcomes for patients with mHSPC. The study will help determine if this new combination treatment can help control the cancer more effectively than the standard care alone. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, informed consent is required. This ensures understanding of the study’s purpose and procedures.

Eligibility is confirmed based on specific criteria, including age, health status, and medical history related to prostate cancer.

2 randomization

Participants are randomly assigned to one of two groups: one receiving 177Lu-PSMA-617 with standard care, and the other receiving standard care alone.

This process ensures unbiased comparison between the two treatment approaches.

3 treatment phase

For those receiving 177Lu-PSMA-617, the medication is administered as a solution for injection or infusion.

Standard care may include medications such as relugolix, goserelin acetate, triptorelin acetate, degarelix, and others, depending on individual treatment plans.

4 monitoring and assessments

Regular monitoring is conducted to assess the effectiveness of the treatment. This includes imaging tests to track disease progression.

Blood tests and other evaluations are performed to monitor health status and any side effects.

5 follow-up

Participants continue to be monitored for overall survival and progression-free survival.

Additional assessments may include quality of life evaluations and tracking of any adverse events.

6 completion of the study

The study is expected to conclude by February 2026.

Final results will be analyzed to determine the effectiveness and safety of the treatment options.

Who Can Join the Study?

  • You must sign a form to show you understand and agree to participate in the study.
  • If you have HIV but are healthy and have a low risk of developing AIDS-related issues, you can join the trial.
  • You should be either new to treatment or have had minimal treatment for prostate cancer. This means:
    • Up to 45 days of certain hormone treatments or surgery to remove the testicles is allowed before signing the consent form. If you took a specific type of medication called first-generation antiandrogen, it must be stopped before starting the study treatment or after 45 days, whichever comes first.
    • If you had hormone treatments in the past for early-stage prostate cancer, they must have been stopped more than 12 months before signing the consent form, and the treatment should not have lasted more than 24 months. Also, the cancer should not have worsened within 12 months after stopping the treatment.
    • Up to 45 days of certain other medications for prostate cancer is allowed before signing the consent form, but not for earlier stages of prostate cancer.
  • You must be an adult, at least 18 years old.
  • Your ability to perform daily activities should be rated between 0 to 2 on a specific scale used by doctors, known as the ECOG performance status.
  • You should have a life expectancy of more than 9 months, as determined by the study doctor.
  • You must have prostate cancer that has spread to other parts of the body, confirmed by a biopsy, which is a test that examines tissue samples.
  • Your cancer must show PSMA-positive results on a special scan called a 68Ga-PSMA-11 PET/CT scan, and you must be eligible as determined by the study’s central reader.
  • You must have at least one area where the cancer has spread, either to the bones or other tissues, documented within 28 days before starting the study. This can be shown by:
    • Cancer in the bones visible on a specific type of bone scan.
    • Cancer in the lymph nodes, which are small glands that help fight infection. If lymph nodes are the only area affected, at least one must be a certain size and located outside the pelvis.
    • Cancer in other organs, known as visceral metastases. If you had this type of spread before starting hormone treatment and it disappeared, it will still be counted as having spread for study purposes.
  • Your organs must be working well, which means:
    • Your bone marrow, which produces blood cells, should have enough reserves. This is measured by certain blood counts.
    • Your liver function should be within normal limits, with some allowances for specific conditions like Gilbert’s Syndrome.
    • Your kidneys should be functioning well, measured by a test called eGFR.
  • Your blood protein level, known as albumin, should be at least 2.5 g/dL.

Who Cannot Join the Study?

  • Patients who do not have PSMA-positive metastatic hormone-sensitive prostate cancer cannot participate. This means the cancer must have spread to other parts of the body and still responds to hormone treatment.
  • Only male patients are eligible for this study.
  • Patients who are part of a vulnerable population are not eligible. This generally refers to groups who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Centre Jean Perrin Clermont Ferrand France
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Rostock University Medical Center Rostock Germany
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Region Skane Skanes Universitetssjukhus Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Hospital Clinic De Barcelona Barcelona Spain
Karolinska University Hospital Solna Sweden
Stichting Radboud University Medical Center Nijmegen The Netherlands
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Reinier de Graaf Groep Delft The Netherlands
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
Cvjaxrcbc Uvopxikxthdufk Szixpzhxx Woluwe-Saint-Lambert Belgium
Immelzdx Rhponnsn Df Cqiftp Di Mtfgggnjvqa Montpellier France
Cclevm Lirm Btpwyh Lyon France
Urinwfmlkeregkoumdiws Edyxe Ads Essen Germany
Owlmxbdelcjnao Loud Geie Linz Austria
Pxvs Trocf Hbehsfev Uxxcxuklnxut Sabadell Spain
Uhldxvyitk Hcuqvkyr Cvblprq Cologne Germany
Fwxjgmxm nkrmypumr Msomt a Himjvet Prague Czechia
Uzwlxolstrtlqqcnsptoj Mvdaafua All Munster Germany
Czra Dp Nhhor Vandoeuvre Les Nancy France
Nlekxkyg Iyorghvw Oskvgblxz Iii Mvosl Spnvezjqgxyptdkvfuybwgwanxfx Iaxjkknb Bholnxiu Cracow Poland
Uqrpqkaoimbffklqhoanp Wgaprlgli Aww Wuerzburg Germany
Ffoocxvnr Psna Ls Irxqwhgwjncfe Bvhazktfo Dze Hrdiridb Uqudjshctfjyw Lu Pwu Madrid Spain
Hvphmpif Viyf dejzlagb Barcelona Spain
Htdgxwpj Uoankixotdwejs Sekeumtiyg &cuffnn Hahiipe ds Huvcvixwirg STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
09.06.2021
Belgium Belgium
Not recruiting
09.06.2021
Czechia Czechia
Not recruiting
09.06.2021
Denmark Denmark
Not recruiting
09.06.2021
France France
Not recruiting
09.06.2021
Germany Germany
Not recruiting
09.06.2021
Poland Poland
Not recruiting
09.06.2021
Spain Spain
Not recruiting
09.06.2021
Sweden Sweden
Not recruiting
09.06.2021
The Netherlands The Netherlands
Not recruiting
09.06.2021

Trial locations

177Lu-PSMA-617 is a type of targeted therapy used in this clinical trial. It is designed to deliver radiation directly to prostate cancer cells. This medication works by attaching to a specific protein found on the surface of prostate cancer cells, allowing the radiation to target and kill these cells more effectively while minimizing damage to healthy cells.

Standard of Care refers to the regular treatment that patients with metastatic hormone-sensitive prostate cancer typically receive. This can include a combination of hormone therapy, chemotherapy, or other treatments that are commonly used to manage prostate cancer. The exact components of the Standard of Care can vary depending on the patient’s specific condition and the healthcare provider’s recommendations.

PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC) – This is a type of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. The cancer cells express a protein called PSMA, which can be targeted for treatment. As the disease progresses, it may become resistant to hormone therapy, leading to further spread and growth of cancer cells. The progression is often monitored through imaging and PSA levels, which can indicate changes in the cancer’s activity. Over time, the disease may transition to a more advanced stage known as castration-resistant prostate cancer.

Trial ID:
2023-507970-42-00
Protocol code:
CAAA617C12301
Trial Phase:
Therapeutic confirmatory (Phase III)

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