Study on Adding Apalutamide to Radiotherapy and LHRH Agonist for High-Risk Patients with Hormone-Sensitive Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a treatment for high-risk hormone-sensitive prostate cancer. The study is investigating the effectiveness and safety of adding a medication called Apalutamide to a combination of radiotherapy and a type of hormone therapy known as LHRH agonist. The goal is to see if this combination can delay the spread of cancer or death compared to using just radiotherapy and LHRH agonist alone. The study will use a special imaging technique called PSMA-PET to assess the cancer’s progression.

Participants in the study will receive either the combination of Apalutamide, radiotherapy, and LHRH agonist or just radiotherapy and LHRH agonist. The study will also include an observational group to gather additional information. Apalutamide is taken as a tablet by mouth, while radiotherapy is a treatment that uses high-energy rays to target cancer cells. The LHRH agonist is a type of hormone therapy that is given as an injection under the skin. The study will monitor participants over a period to observe the effects of the treatments.

The study aims to provide valuable insights into whether adding Apalutamide can improve outcomes for patients with high-risk hormone-sensitive prostate cancer. By using PSMA-PET, a type of imaging that helps visualize prostate cancer, researchers hope to better understand how the cancer responds to the treatment. This trial is an important step in exploring new ways to manage and treat prostate cancer effectively.

1 joining the study

Upon joining the study, the participant will have signed an informed consent form, indicating understanding and willingness to participate in the study.

The participant must be 18 years or older and have a confirmed diagnosis of high-risk recurrent prostate cancer previously treated with radical prostatectomy.

2 initial assessment

An initial assessment will be conducted to confirm eligibility, including a review of medical history and current health status.

The participant must have adequate organ function and be able to swallow the study drug tablets or follow instructions for admixing with apple sauce.

3 treatment phase

The treatment phase involves the administration of apalutamide in combination with radiotherapy and LHRH agonist.

Apalutamide is provided in the form of film-coated tablets for oral use. The dosage and frequency will be determined by the study protocol.

Participants receiving bone-loss prevention treatment must be on stable doses for at least 4 weeks before randomization.

4 monitoring and follow-up

Regular monitoring will be conducted to assess the participant’s response to treatment and any side effects.

The primary endpoint is PSMA-PET metastatic progression-free survival, which is the time from randomization to the date of metastatic progression or death from any cause.

5 end of treatment

The treatment phase will conclude as per the study protocol, and participants will be monitored for a specified period after the last dose of the study drug.

Participants must agree not to donate sperm for reproduction during the treatment phase and for a minimum of 3 months after the last dose.

Who Can Join the Study?

Must be a person aged 18 years or older.
Must have adequate organ function, which means:
- Levels of certain liver enzymes (AST and ALT) should be no more than 2.5 times the normal limit.
- Total bilirubin, a substance made by the liver, should be no more than 1.5 times the normal limit.
- Serum creatinine, a waste product in the blood, should be less than 1.8 mg/dL.
- Platelets, which help with blood clotting, should be at least 75,000 per microliter without recent transfusions or growth factors.
- Hemoglobin, a protein in red blood cells, should be at least 10.0 g/dL without recent transfusions or growth factors.
Must be able to swallow the study drug tablets or mix them with applesauce.
If engaging in sexual activity with a person who can become pregnant, a condom must be used along with another effective birth control method during the treatment and for 3 months after the last dose.
Must agree not to donate sperm for reproduction during the treatment and for at least 3 months after the last dose.
If receiving treatment to prevent bone loss, must be on stable doses for at least 4 weeks before starting the study.
Must be planned to receive a specific type of radiation therapy for prostate cancer.
Must sign an Informed Consent Form, showing understanding and willingness to participate in the study.
Must have a confirmed diagnosis of prostate cancer.
Must have been previously treated with a surgery called radical prostatectomy, with specific conditions related to PSA levels, a protein produced by the prostate.
Must be at high risk of cancer spreading, based on certain medical criteria like a high Gleason score, which is a grading system for prostate cancer.
Results from a specific scan called PSMA-PET must meet certain conditions regarding cancer lesions.
If there is evidence of cancer spread on a PSMA-PET scan, there must be no evidence of spread on other scans like CT, MRI, or bone scans. If a single bone lesion is found, it must be confirmed by another scan.
Must have a performance status of Grade 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.

Who Cannot Join the Study?

Patients who have not been diagnosed with high risk recurrent prostate cancer that was previously treated with surgery to remove the prostate.
Patients who are female, as the study is only for male participants.
Patients who are part of a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Of Debrecen	Debrecen	Hungary
Soedersjukhuset AB	Stockholm	Sweden
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Fakultni nemocnice Motol a Homolka	Prague	Czechia
Herlev Hospital	Herlev	Denmark
Ospedale San Raffaele S.r.l.	Milan	Italy
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Helsinki University Central Hospital	Helsinki	Finland
Universitaetsklinikum Muenster AöR	Munster	Germany
Aalborg University Hospital	Aalborg	Denmark
Gasthuiszusters Antwerpen	Antwerp	Belgium
Sankt Gorans Sjukhus	Stockholm	Sweden
Rigshospitalet	Copenhagen	Denmark
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Uniwersyteckie Centrum Kliniczne	Gdansk	Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Essen AöR	Essen	Germany
I.F.O. Istituti Fisioterapici Ospitalieri	Rome	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Technische Universitaet Dresden	Dresden	Germany
Ordensklinikum Linz GmbH	Linz	Austria
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz	Madrid	Spain
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi	Lodz	Poland
Univerzitna Nemocnica Martin	Martin	Slovakia
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Uniklinikum Salzburg	Salzburg	Austria
Fakultni Nemocnice Plzen	Plzen	Czechia
Orszagos Onkologiai Intezet	Budapest	Hungary
Varsinais-Suomen hyvinvointialue	Turku	Finland
Nu Med Grupa S.A.	Elblag	Poland
Pohjois-Pohjanmaan hyvinvointialue	Oulu	Finland
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Aarhus University Hospital	Aarhus	Denmark
Champalimaud Clinical Centre	Lisbon	Portugal
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Pirkanmaan hyvinvointialue	Tampere	Finland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Vychodoslovensky Onkologicky Ustav a.s.	Kosice	Slovakia
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Centro Hospitalar Universitario Do Porto E.P.E.	Porto	Portugal

Other Sites

Site Name	City	Country
Hospital Da Luz S.A.	Lisbon	Portugal
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Urocentrum Praha s.r.o.	Prague	Czechia
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Buprgaaih Uriuxq Udxuh Kewfcz	Budapest	Hungary
Apjjjddd Zsbvorywyc Gziialmhz	Kortrijk	Belgium
Surqnjvt Plrwfjmhw Saj z obgg	Gdynia	Poland
Ekbwzppbrfb Solno Juoft Clujjhdpynrns	Budapest	Hungary
Bjojgutvvdbpnztmw Kdzlxs Ew Rblezvrzsqvxkm	Budapest	Hungary
Uoamqxe sfcze s rgof	Nitra	Slovakia
Mupibpnf smjzgw	Presov	Slovakia
Hfjfxxlm Cqf Tqae Sqhq	Lisbon	Portugal
Jizd Fzvobk Drcuiwxfa Keyzcd Ev Rqbuhhvcnuaeex	Budapest	Hungary
Kcojjlr Nvsfhyrtfgcgptfdtao Sni z oahy	Radom	Poland
Voqiptlu Ntvoxljt finm Gsbgjvgzbh Gqzm	Berlin	Germany
Hmwkagdh Dp Swtre Mvkxf Ewycqg	Lisbon	Portugal
Amoe Sgqlrnnhc Df Fhbbxn	Ferrol	Spain
Uuxupna Loikq Dt Sfawx Dw Efnoi O Dybsp E Vwrob Entsvz	Santa Maria Da Feira	Portugal
Vxznn Cpfansg Hlmnzwjy	Vaasa	Finland
Piuwallh Upijoxosye Anupcieibs sdtbia	Trencin	Slovakia
Voapdgphw Fkhtgwht Nyuindaal V Pycdr	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	17.11.2020
Belgium	Not recruiting	17.11.2020
Czechia	Not recruiting	17.11.2020
Denmark	Not recruiting	17.11.2020
Finland	Not recruiting	17.11.2020
Germany	Not recruiting	17.11.2020
Hungary	Not recruiting	17.11.2020
Italy	Not recruiting	17.11.2020
Poland	Not recruiting	17.11.2020
Portugal	Not recruiting	17.11.2020
Slovakia	Not recruiting	17.11.2020
Spain	Not recruiting	17.11.2020
Sweden	Not recruiting	17.11.2020

Trial locations

Investigated Drugs:

Apalutamide

Apalutamide is a medication used in this trial to treat high-risk patients with hormone-sensitive prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. The study aims to see if adding apalutamide to the standard treatment can delay the spread of cancer or death.

Radiotherapy (RT) is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, it is used as part of the standard treatment for prostate cancer to help control the disease and reduce the risk of it spreading.

LHRH Agonist is a type of hormone therapy used to lower the levels of male hormones in the body, which can help slow down or stop the growth of prostate cancer cells. It is part of the standard treatment in this trial, combined with radiotherapy, to manage hormone-sensitive prostate cancer.

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause urinary problems, pelvic discomfort, or bone pain. The cancer can spread to other parts of the body, such as bones and lymph nodes. The progression is typically monitored through imaging tests and blood markers. Treatment aims to manage the disease and prevent further spread.

Trial ID:

2023-505852-23-00

Protocol code:

56021927PCR3015

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Adding Apalutamide to Radiotherapy and LHRH Agonist for High-Risk Patients with Hormone-Sensitive Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?