Study on the Effectiveness of Lutetium (177Lu) Vipivotide Tetraxetan 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). This is a form of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. The study is specifically looking at patients whose cancer does not respond well to the current standard treatments. The treatment being tested in this study is called 177Lu-PSMA-617, which is a type of radiopharmaceutical. This means it is a radioactive substance used to target and treat cancer cells. The study will compare the effects of adding 177Lu-PSMA-617 to the usual treatments against using the usual treatments alone.

The purpose of the study is to see if adding 177Lu-PSMA-617 can help control the disease better than the standard treatments alone. The standard treatments may include medications such as enzalutamide, apalutamide, darolutamide, and abiraterone acetate, which are taken orally, as well as Pluvicto, which is given as an injection or infusion. The study will involve regular monitoring of the patients’ health and response to the treatment over a period of time. This will help researchers understand the effectiveness and safety of the new treatment approach.

Participants in the study will receive either the standard treatment alone or the standard treatment plus 177Lu-PSMA-617. The study will track how long patients live and how long they remain free from cancer progression. It will also look at other factors such as quality of life and any side effects experienced. The goal is to determine if the new treatment can improve outcomes for patients with this type of prostate cancer.

1 Joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving the standard treatment and the other receiving the standard treatment plus an additional medication called 177Lu-PSMA-617.

The purpose of this study is to evaluate the effectiveness and safety of adding 177Lu-PSMA-617 to the standard treatment for prostate cancer that has spread and does not respond well to current treatments.

2 Initial treatment phase

Patients will continue their ongoing standard treatment, which may include medications such as enzalutamide, apalutamide, darolutamide, or abiraterone acetate. These are taken orally.

The additional medication, 177Lu-PSMA-617, will be administered intravenously. The frequency and duration of this treatment will be determined by the study protocol.

3 Monitoring and assessments

Throughout the study, regular assessments will be conducted to monitor the patient’s health and the effectiveness of the treatment. This includes blood tests, imaging scans, and other evaluations as required.

The patient’s prostate-specific antigen (PSA) levels will be closely monitored to assess the response to treatment.

4 Follow-up phase

After completing the treatment phase, patients will enter a follow-up period where their health and any long-term effects of the treatment will be monitored.

This phase includes regular visits and assessments to ensure the patient’s well-being and to gather data on the treatment’s long-term effectiveness.

Who Can Join the Study?

Sign a written informed consent form before any trial-specific procedures. If unable to sign, a trusted representative can sign on behalf of the patient.
Have a stable or declining PSA level, but not a rising one. PSA is a protein produced by the prostate, and its level is checked in the blood.
Have a serum PSA level of at least 0.2 ng/mL at 6 to 8 months after starting systemic treatment for prostate cancer.
Have a testosterone level below 50 ng/dL or 1.7 nmol/L. Testosterone is a hormone that can affect prostate cancer.
Be healthy enough for 177Lu-PSMA-617 treatment, which includes having:
- Adequate bone marrow function: hemoglobin of at least 90 g/L, a type of white blood cell count of at least 1.5 x 10⁹/L, and a platelet count over 100 x 10⁹/L.
- Adequate liver function: certain liver enzymes (AST and ALT) should be no more than 2 times the normal limit, or 5 times if there are liver metastases; bilirubin should be less than 1.5 times the normal limit, unless there is a known condition called Gilbert syndrome, then less than 3 times is allowed.
- Adequate kidney function: a calculated creatinine clearance of at least 50 ml/min, which measures how well the kidneys are working.
If sexually active with female partners who can become pregnant or are pregnant, agree to use a condom with another effective birth control method during the trial and for 14 weeks after completing the study treatment.
Be affiliated with the social security system or have equivalent private health insurance, as required by local regulations for clinical trial participation.
Be willing and able to follow the trial protocol, including undergoing treatment, attending scheduled visits, and having examinations, including follow-up.
Be at least 18 years old.
Have a life expectancy of more than 6 months, as estimated by the investigator.
Have an ECOG performance status of 2 or less. This is a scale used to assess how a disease affects a patient’s daily living abilities.
Be a man with prostate cancer confirmed by tissue examination (histologically or cytologically).
Have newly diagnosed metastatic disease, meaning cancer has spread to other parts of the body, confirmed by clinical or imaging evidence at diagnosis. If not available, more recent imaging can be used.
Have measurable disease or bone lesions that can be evaluated according to specific criteria (PCWG3). Patients with uncertain metastases are not eligible.
Have a 68Ga-PSMA-11 PET/CT scan done within 4 weeks before randomization in the trial. An FDG PET scan is not required. Patients can participate regardless of the PSMA PET scan results.
Have had 6 to 8 months of previous and ongoing standard systemic treatment for prostate cancer, which includes:
- ADT (androgen deprivation therapy) with docetaxel, with or without radiotherapy.
- ADT with an androgen receptor signaling inhibitor (ARSI) like abiraterone (plus prednisone), apalutamide, darolutamide, or enzalutamide, with or without radiotherapy.
- ADT with docetaxel plus an ARSI, with or without radiotherapy.
Note: Docetaxel must have been stopped at least 4 weeks before randomization. Previous radiotherapy to the primary tumor or metastases is accepted if it was not PSMA-based and completed at least 4 weeks before randomization.

Who Cannot Join the Study?

Patients who have shown signs of cancer progression, such as an increase in their PSA level, cannot participate. PSA stands for Prostate-Specific Antigen, a substance produced by the prostate gland. A rising level may indicate cancer growth.
Patients who are not male are excluded from the study.
Patients who are considered part of a vulnerable population, meaning they may have additional health or social challenges, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Centre Jean Perrin	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
University Hospital Maastricht	Maastricht	The Netherlands
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Katholieke Universiteit te Leuven	Leuven	Belgium
CHU Grenoble Alpes	La Tronche	France
Comite Entreprise Paul Papin	Angers	France
Institut Curie – Site Paris	Paris	France
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Grand Hopital De Charleroi	Charleroi	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Henri Becquerel	Rouen	France
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
CHU Helora	La Louviere	Belgium
Hopital Beaujon	Clichy	France
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Del Mar	Barcelona	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Cnxpas Ldbj Bocppr	Lyon	France
Pmldzhvkxvn Sevvjllojvwtfojrb	Bologna	Italy
Cfhxzg Hzxvhhlcrqm Rkcdrnsy Ujtohupfioubk Dz Terty	Tours	France
Czqh Dz Nwxxk	Vandoeuvre Les Nancy	France
Pcvm Thajh Hnzrkbmw Uvgbaxycktzo	Sabadell	Spain
Ixabjhej Coayiv Ddfmphcpvwifwtwim	L'hospitalet De Llobregat	Spain
Ilsnunmch Oaqghjblff Dtd Rxfqam Sjds	Barcelona	Spain
Sf Vdazdehqztbnsun Uqdzeybiib Hyfmeasj	Dublin	Ireland
Ilgqfkrt dn Colxfmofrqpo Hdgiadhkchp Upppwxsrpmmnw dd Scvpe Eoalgba (fygkbbo	Saint Priest En Jarez	France
Huyxifwl Vkof dfpuitnf	Barcelona	Spain
Ibemtcbw Pgygnbdxxrbwxdt Cfqibi Cddrpk	Marseille	France
Craucl Ocrqj Lukwgbn	Lille	France
Hfsvotmg Uexetthaildayw Sgqgxaattn &qaxuvc Hzegine df Hbkljrmavkg	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	01.03.2024
France	Recruiting	01.03.2024
Ireland	Not yet recruiting	01.03.2024
Italy	Not yet recruiting	01.03.2024
Spain	Not yet recruiting	01.03.2024
The Netherlands	Not yet recruiting	01.03.2024

Trial locations

Investigated drugs:

177Lu-PSMA-617 is a targeted therapy used in this trial for patients with metastatic hormone-sensitive prostate cancer. It works by delivering radiation directly to prostate cancer cells, which helps to destroy them while minimizing damage to surrounding healthy tissue. This medication is being tested to see if it improves survival and delays disease progression when added to the standard treatment for prostate cancer.

Standard of Care (SoC) refers to the usual treatment regimen that patients with metastatic hormone-sensitive prostate cancer receive. This can include a combination of hormone therapy, chemotherapy, or other medications that are commonly used to manage prostate cancer. The trial is comparing the effects of adding 177Lu-PSMA-617 to this standard treatment to see if it offers additional benefits.

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. It is characterized by the presence of cancer cells in distant organs or bones, while the primary tumor remains in the prostate gland. Patients with mHSPC often have elevated levels of prostate-specific antigen (PSA) in their blood. The disease progresses as cancer cells continue to grow and spread, despite initial responses to hormone therapy. Over time, the cancer may become resistant to hormone treatments, leading to more aggressive disease behavior. Monitoring PSA levels and imaging studies are commonly used to assess disease progression.

Trial ID:

2022-502408-57-00

Protocol code:

UC-GTG-2301

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Lutetium (177Lu) Vipivotide Tetraxetan with Standard Treatment for Men with Metastatic Hormone-Sensitive Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?