A study of saruparib with radiotherapy and hormone therapy for men with high-risk prostate cancer who have a BRCA gene mutation

3 1 1

What is this study about?

This study involves men with prostate cancer that has a specific change in genes called BRCA1 or BRCA2 mutation. The cancer is considered high-risk or very high-risk but is still located in the prostate area or nearby tissues, meaning it has not spread to distant parts of the body. The study uses several medications including Saruparib, which is also known by its code name AZD5305, along with Zytiga which contains abiraterone acetate. These treatments are given in addition to standard care that includes radiotherapy and androgen deprivation therapy, which is a treatment that lowers male hormones that can help prostate cancer grow. Some participants will receive placebo instead of the active study medication. Saruparib works as an inhibitor of PARP, which is a substance in cells, while abiraterone acetate is an androgen biosynthesis inhibitor that blocks the production of male hormones.

The purpose of the study is to find out if adding Saruparib to the standard treatment of radiotherapy and androgen deprivation therapy can help men with this type of prostate cancer live longer without the cancer spreading to distant parts of the body compared to placebo. The study will measure how long participants remain free of distant spread of cancer, which is called metastases-free survival, and will also look at overall survival and other measures of how well the treatment works. During the study, participants will receive the study medication in tablet form taken by mouth, and they will need to have various scans including computed tomography or magnetic resonance imaging, bone scans, and prostate-specific membrane antigen-positron emission tomography scans to check for any signs of cancer spread.

Participants will be randomly assigned to receive either the active study medication or placebo in addition to their standard treatment, and neither the participants nor their doctors will know which treatment they are receiving during the study. The study requires tissue samples from the prostate cancer to confirm the presence of the BRCA gene mutation before enrollment. Throughout the study, participants will be monitored for how the treatment affects their cancer, their overall health, and their quality of life through questionnaires about symptoms and daily functioning. Blood samples will also be collected to measure the levels of the study medication in the body and to understand how it works.

1 Starting treatment after joining the study

After joining the study, you will be randomly assigned to receive either saruparib or a placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.

This assignment is done by chance, similar to flipping a coin. Neither you nor your doctor will know which treatment you are receiving during the study. This is called a double-blind design.

The study medication will be added to your standard treatment, which includes radiation therapy and androgen deprivation therapy. Androgen deprivation therapy is a hormone treatment that lowers male hormone levels in your body.

2 Taking the study medication

You will take the study medication by mouth. The medication comes in the form of tablets.

If you are assigned to receive saruparib, you will take saruparib tablets. If you are assigned to the placebo group, you will take placebo tablets that look identical to the saruparib tablets.

The exact dosage, frequency, and duration of taking the tablets will be explained to you by the study staff based on the study protocol.

3 Continuing hormone therapy

Throughout the study, you will continue receiving androgen deprivation therapy using a medication called a gonadotropin releasing hormone analogue. This medication helps lower testosterone levels in your body.

Some participants may also receive abiraterone acetate, which is another medication used to lower hormone levels. Abiraterone acetate is available as ZYTIGA in two strengths: 250 mg tablets or 500 mg film-coated tablets.

If prescribed, abiraterone acetate is taken by mouth according to the dosing schedule provided by your doctor.

4 Undergoing imaging scans during the study

During the study, you will have regular imaging scans to monitor your condition. These scans help doctors see if there are any changes in your body.

The scans may include computed tomography (also called CT scan), magnetic resonance imaging (also called MRI), and bone scans. These are imaging tests that create pictures of the inside of your body.

You may also have a specialized scan called prostate-specific membrane antigen-positron emission tomography (also called PSMA-PET). This is a type of scan that can detect prostate cancer cells in your body.

These scans will be performed at specific time points throughout the study as outlined in the study schedule.

5 Attending regular study visits

You will need to attend regular visits throughout the study. During these visits, the study staff will check your health and how you are responding to the treatment.

At these visits, blood samples may be collected to measure various markers, including prostate-specific antigen (also called PSA), which is a protein produced by prostate cells that can indicate disease activity.

Blood samples may also be taken to measure the levels of the study medication in your blood. This is called pharmacokinetic testing and helps understand how your body processes the medication.

Your overall health status will be assessed using the Eastern Cooperative Oncology Group performance status scale, which measures how the disease affects your daily living abilities.

6 Completing quality of life questionnaires

During the study, you will be asked to complete questionnaires about your quality of life and symptoms.

These questionnaires include the EORTC-QLQ-C30, which asks about your general well-being and physical functioning, and the EORTC-QLQ-PR25, which asks specifically about urinary symptoms related to prostate conditions.

Your answers will help doctors understand how the treatment affects your daily life and symptoms.

7 Following contraception requirements

Throughout the study and for 6 months after taking the last dose of study medication, you must use a condom during any sexual activity.

You must not father children or donate sperm from the time you join the study until 6 months after your last dose of study medication.

These measures are necessary to prevent potential risks to unborn children.

8 Continuing study participation

The study will continue for an extended period to assess long-term outcomes. The estimated end date for the study is April 2036.

During this time, doctors will monitor for the appearance of distant metastases, which means cancer spreading to other parts of your body beyond the pelvis.

The study will also track other important outcomes, including overall survival, which means how long participants live, and prostate cancer-specific survival, which means survival specifically related to prostate cancer.

If your disease progresses and you require additional treatment, information about any new treatments you receive will be collected as part of the study follow-up.

Who Can Join the Study?

    Requirements you must meet to participate in this study:

  • You must be male with a diagnosis of prostate adenocarcinoma, which is a type of cancer that starts in the prostate gland, confirmed by examining tissue under a microscope
  • You must have already received radiation therapy, which is a treatment that uses high-energy rays to destroy cancer cells, either as your first treatment or as a second treatment after surgery
  • Your radiation therapy must have been given with the goal of curing your cancer, not just controlling symptoms
  • You must have received or be receiving androgen deprivation therapy, which is a treatment that lowers male hormones that can help prostate cancer grow, using medications called GnRH analogues
  • You must have been diagnosed with high-risk or very high-risk prostate cancer that has not spread beyond the local area, or you must have experienced a return of cancer signs after prostate surgery
  • You must provide a sample of your tumor tissue that has been preserved in a special way for testing
  • Your tumor tissue must show a change in genes called BRCA1 or BRCA2 mutations, which are changes in genes that normally help prevent cancer
  • You must have imaging scans after completing radiation therapy, including a CT scan or MRI scan, which are tests that create detailed pictures of the inside of your body, and a bone scan, which checks for cancer in your bones
  • These scans must show either no signs of cancer or cancer only in the pelvic area, meaning the cancer has not spread to distant parts of your body
  • You must also have a special scan called a PSMA-PET scan after radiation therapy, which is a very sensitive test that looks for prostate cancer cells, and this scan must show no cancer or cancer only in the pelvic area
  • Your general health and ability to care for yourself must be good, rated as 0 or 1 on a scale called ECOG performance status, which measures how cancer affects your daily activities, and this must be stable for at least 2 weeks
  • Your doctors must expect that you will live at least 12 months
  • Your organs and blood cells must be working well enough according to specific laboratory test results
  • You must agree not to father children or donate sperm from the time you sign the consent form, during the entire study, and for 6 months after your last dose of study medication
  • You must agree to use a condom with spermicide during any sexual activity from the time you sign the consent form, during the study, and for 6 months after your last dose of study medication

Who Cannot Join the Study?

  • The study is only for male patients, so women cannot participate
  • Patients who do not have prostate cancer, which is a disease affecting the prostate gland in men, cannot participate
  • Patients whose prostate cancer is not classified as high-risk or very high-risk, meaning the cancer is less aggressive or less advanced, cannot participate
  • Patients who do not have a BRCA gene mutation, which is a specific change in genes that can be inherited and increases cancer risk, cannot participate
  • Patients whose prostate cancer is not localized or locally advanced, meaning the cancer has already spread far beyond the prostate area, cannot participate
  • Patients who are not suitable for radiation therapy, which is a treatment using high-energy rays to kill cancer cells, combined with androgen deprivation therapy, which is a treatment that lowers male hormones to slow cancer growth, cannot participate

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
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Kuopio University Hospital Kuopio Finland
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Centre Jean Perrin Clermont Ferrand France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Clinico San Carlos Madrid Spain
Medical University Of Graz Graz Austria
University Hospital Maastricht Maastricht The Netherlands
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Centre Antoine Lacassagne Nice France
Hopital Tenon Paris France
Institut Jules Bordet Anderlecht Belgium
Orszagos Onkologiai Intezet Budapest Hungary
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Region Vaesterbotten Umea Sweden
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Barmherzige Brueder Trier gGmbH Trier Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Algemeen Ziekenhuis Delta Roeselare Belgium
Tergooiziekenhuizen Hilversum The Netherlands
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Centre De Cancerologue Du Grand Montpellier Montpellier France
Oulu University Hospital Oulu Finland
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
ARNAS Civico Di Cristina Benfratelli Palermo Italy
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Krankenhaus Der Barmherzigen Brueder Wien Vienna Austria
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
University Of Debrecen Debrecen Hungary
Ospedale San Raffaele S.r.l. Milan Italy
Karolinska University Hospital Solna Sweden
Philipps-Universitaet Marburg Marburg Germany
Semmelweis University Budapest Hungary
IRCCS Ospedale Policlinico San Martino Genoa Italy
Turku University Hospital Turku Finland
Hospital General Universitario De Valencia Valencia Spain
Gasthuiszusters Antwerpen Antwerp Belgium
Pratia S.A. Skorzewo Poland
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Justus-Liebig-Universitaet Giessen Giessen Germany
Sankt Gorans Sjukhus Stockholm Sweden
Cliniche Gavazzeni S.p.A. Bergamo Italy
Bravis Ziekenhuis Roosendaal The Netherlands
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti Chieti Italy
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Azienda USL Toscana Sud Est Arezzo Italy
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Pirkanmaan hyvinvointialue Tampere Finland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Vrije Universiteit Brussel Jette Belgium
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Clinique Victor Hugo Le Mans France
Provita Centrum Medyczne Sp. z o.o. Tomaszow Mazowiecki Poland
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Oncoradio Centre Oncogard Nimes France
Hospital Universitario Virgen De La Victoria Malaga Spain
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari Italy
Urologicum Duisburg Duisburg Germany
Cfukguegu Uoodydcszfoalj Scjrmsttx Woluwe-Saint-Lambert Belgium
Ifhyeclz Rdguhugs Df Cviwlo Dj Mdylmzitlwa Montpellier France
Uxbeidwexi Mksthwp Cgxgsu Hvvdtpazpwcezzygk Hamburg Germany
Upgawzkfiraytetxkvufp Ellsh Ayo Essen Germany
Ibogxl Ibkvtrpt Ffbbkhjpmeywy Oobpptpcjic Rome Italy
Ogeveifmymulqz Lncg Gvws Linz Austria
Haiercgm Uradhzkwnbrls Mbgfknx Dh Vszzyuphik Santander Spain
Uyqkyfumbtopyiagxrioo Avqcghgk Augsburg Germany
Snxpdcik Pwcgenxyg Szj z owgd Gdynia Poland
Dhpppygy Ol Helsinki Finland
Pegf Tllde Hzxbmczg Uppeclmouxea Sabadell Spain
Udxvxdvpgc Hyeyajop Cttoyom Cologne Germany
Uuuvigz Undjnhcasm Hikgssco Uppsala Sweden
Uffcappunkzjjfiogiauc Djzgmarlshj Aiy Duesseldorf Germany
Hbbnsonz Uxfmxujlmy Crncjcb Haxxdhbb Helsinki Finland
Ciffny Hcddqnwyrql Rzbwihmz Ucltgbvqggxpz Da Tdfsw Tours France
Awtcnqv Ocrchjfzbfp Uzfjwfjmeywia Ceyomsrtrfaq Dgcqb Szcaph E Dqufm Syxpqlp Dr Tjfqzv Turin Italy
Gfhjgqeocuvtlsexy Vistlqolc Pllb Arafre Elaxicda Oizoez Kfvmwm Gyor Hungary
Nvhytmoh Ivlbrbmv Oazjbgues Igf Mhyun Scumjaofluxcjoojwkyarkaocike Itqponlm Bkgyvarg Cracow Poland
Uftauczfhwaijbvqnudfh Whzaobkyq Aga Wuerzburg Germany
Hklofqnz Db Lo Sqadn Clyb I Sqvm Piv Barcelona Spain
Aprnrvb Ofalnbnxojz Pkbg Gubrfazs Xvkmo Bergamo Italy
Gncont Hdyxixlpmgl Uxwahjjvcddnu Ptfka Pgtuqbnerfq Ey Nqtohwhclpip Paris France
Ioournvu Ceomzl Dkwolgjofzjppyqnu L'hospitalet De Llobregat Spain
Fdyllmzld Phdn Lw Iofuhqwjfjrrv Bucrtqvii Dpv Hqutcfge Uvpjyeleqmpjs Li Pdg Madrid Spain
Inufewnk dr Cjaygywiykmg Hbihwkdowol Uwwygexvewfwc dl Snjcc Etgrnla (efkkppf Saint Priest En Jarez France
Hhiihmoc Vmqk dytlsaer Barcelona Spain
Iafetwdd Pasjwfxkcveqbiw Cpmhab Cpaigm Marseille France
Hwmctqzq Uqnmxztqqosyqo Syqvjalcnq &wtrqfk Hbiczsn dt Hxyrcdukimm 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
Recruiting
01.11.2025
Belgium Belgium
Recruiting
01.11.2025
Finland Finland
Recruiting
01.11.2025
France France
Recruiting
01.11.2025
Germany Germany
Recruiting
01.11.2025
Hungary Hungary
Recruiting
01.11.2025
Italy Italy
Recruiting
01.11.2025
Poland Poland
Recruiting
01.11.2025
Spain Spain
Recruiting
01.11.2025
Sweden Sweden
Recruiting
01.11.2025
The Netherlands The Netherlands
Recruiting
01.11.2025

Trial locations

Saruparib (AZD5305) is an experimental medication being tested in this trial. It is given in addition to standard radiation therapy and hormone therapy to see if it can help prevent prostate cancer from spreading to other parts of the body in patients who have a specific genetic change called a BRCA mutation.

Radiation therapy is a standard cancer treatment that uses high-energy rays to kill cancer cells in the prostate area. All participants in this study will receive this treatment.

Androgen deprivation therapy is a hormone treatment that lowers the levels of male hormones in the body or stops them from working. This helps slow the growth of prostate cancer cells. All participants in this study will receive this treatment.

Prostate Cancer – Prostate cancer is a disease that occurs when abnormal cells grow uncontrollably in the prostate gland, which is a small organ in men located below the bladder. The cancer can be confined to the prostate gland itself, which is called localised prostate cancer, or it can spread to nearby tissues, which is referred to as locally advanced prostate cancer. In some cases, the disease progresses and spreads to distant parts of the body, forming metastases in bones or other organs. High-risk and very high-risk prostate cancer refers to forms of the disease that have a greater likelihood of growing and spreading beyond the prostate. Some patients with prostate cancer carry mutations in genes such as the breast cancer gene, which can influence how the disease develops. The progression of prostate cancer can be monitored through imaging tests and measurements of specific markers in the blood.

Trial ID:
2024-513586-39-00
Protocol code:
D9727C00001
NCT ID:
NCT06952803
Trial Phase:
Therapeutic confirmatory (Phase III)

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