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Study of saruparib plus AR inhibitor drug combination in men with metastatic hormone‑sensitive prostate cancer previously treated with docetaxel or Lu‑PSMA and PSA ≥0.2 ng/mL

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on Metastatic Hormone-Sensitive Prostate Cancer, a form of prostate cancer that has spread to other parts of the body but still responds to treatments that lower male hormones. Participants will receive a hormone‑lowering injection such as leuprorelin acetate, relugolix, goserelin or degarelix acetate, and a steroid medication like prednisolone or prednisone. The experimental drug being tested is sarpurib, which will be taken together with a doctor‑chosen androgen receptor pathway inhibitor – options include enzalutamide, abiraterone acetate or darolutamide. Some participants will receive a matching placebo tablet instead of sarpurib.

The main aim of the study is to determine whether adding sarpurib to the hormone‑blocking regimen improves outcomes compared with the same regimen plus placebo. Eligible patients have already been treated with chemotherapy drug docetaxel or targeted radiotherapy Lu-PSMA and still have elevated PSA levels, indicating active disease.

During the trial, participants will take the assigned oral tablets daily and continue their injection therapy, while undergoing regular check‑ups that include blood tests for PSA, imaging scans to look for new cancer spread, and questionnaires about pain, bone health and daily function. The study will monitor how long the disease remains stable without radiographic evidence of growth, known as radiographic progression-free survival, as well as overall survival and other safety measures, until the disease progresses or the participant stops treatment.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Baseline Assessments

    After giving informed consent, you undergo screening examinations that include medical history, physical examination, blood tests, and imaging to confirm eligibility for the study.

    Baseline measurements of prostate‑specific antigen (PSA) and other laboratory values are recorded before any study medication is started.

  2. Step 2

    Randomization

    You are randomly assigned to one of two groups: Saruparib plus a physician‑chosen androgen receptor pathway inhibitor (ARPI), or a matching Placebo plus the same physician‑chosen ARPI.

    The randomization process ensures that the assignment is unknown to you and the study team (double‑blind).

  3. Step 3

    Start of Background Hormone Therapy

    You receive an injection of a hormone‑lowering agent such as Leuprorelin acetate, Goserelin, or Degarelix acetate according to the schedule defined by the study protocol.

    The dose for these injections is listed as 0 mg / ml in the source data; the exact amount and frequency will be determined by the protocol and administered by the study staff.

  4. Step 4

    Start of Androgen Receptor Pathway Inhibitor (ARPI)

    Your physician selects one of the approved ARPIs, which may be Enzalutamide 40 mg film‑coated tablet, Abiraterone acetate 500 mg film‑coated tablet (or 250 mg tablet), or Darolutamide 300 mg film‑coated tablet (brand name NUBEQA).

    The tablets are taken orally; the source data records the dose as 00 mg, indicating that the exact dosage and frequency will follow the study’s dosing schedule.

  5. Step 5

    Start of Study Medication

    If you are in the experimental arm, you begin taking Saruparib tablets; if you are in the control arm, you take matching Placebo tablets.

    Both medications are oral tablets; the source data lists a dose of 00 mg, so the precise amount and how often you take them will be defined by the trial protocol.

  6. Step 6

    Regular Study Visits and Monitoring

    You attend scheduled clinic visits where study staff check your safety, perform blood tests (including PSA), and assess any side effects.

    Imaging studies such as CT, MRI, or bone scans are performed at intervals specified by the protocol to evaluate disease status.

    All assessments are conducted while you continue to take the background hormone therapy, the selected ARPI, and the study medication.

  7. Step 7

    Continuation of Treatment

    You continue the hormone injection, the ARPI tablet, and the study medication for as long as the trial allows, unless disease progression, unacceptable toxicity, or a decision to stop treatment occurs.

    The duration of treatment is not fixed in the provided information; it follows the study’s predefined criteria for continuation or discontinuation.

  8. Step 8

    End of Treatment and Follow‑Up

    If treatment is stopped, you remain in the study for follow‑up visits to monitor overall survival, disease progression, and long‑term safety.

    Follow‑up includes periodic PSA measurements, imaging when indicated, and collection of any additional safety information until the study ends or you withdraw.

Who can join the trial?

15 criteria

  • Be 18 years old or older at the time you sign the consent form.
  • Have a confirmed status for HRR (homologous recombination repair) mutation, HRD (homologous recombination deficiency), and PTEN gene – genetic factors that can affect the cancer.
  • Show adequate organ and bone‑marrow function, meaning your liver, kidneys, and blood‑forming marrow are working well enough for the study.
  • Have a life expectancy of at least 6 months, meaning doctors expect you to live for at least half a year.
  • Be male assigned at birth, inclusive of all gender identities.
  • Use contraception as required by local rules, either yourself or your partner, to prevent pregnancy during the trial.
  • Be able to understand the study and give a signed informed consent.
  • Have a biopsy‑confirmed diagnosis of prostate adenocarcinoma that is either new (de novo) or has returned and is still hormone‑sensitive (responds to hormone therapy).
  • Have metastatic disease (cancer that has spread) confirmed before any previous treatment with docetaxel (a chemotherapy given every 3 weeks) or Lu‑PSMA (a targeted therapy given every 6 weeks) for metastatic hormone‑sensitive prostate cancer.
  • Have received either docetaxel (IV, every 3 weeks) or Lu‑PSMA (IV, every 6 weeks), with the most recent dose given within the past 6 months.
  • Be currently receiving androgen deprivation therapy (ADT) with a GnRH analogue (a drug that lowers testosterone) or have had a bilateral orchiectomy (surgical removal of both testicles); also must have no sign of disease getting worse and any side effects from docetaxel or Lu‑PSMA (except hair loss and mild nerve tingling) must be reduced to CTCAE Grade 1 or lower (very mild).
  • Have a PSA (prostate‑specific antigen) level of at least 0.2 ng/mL measured within 14 days before randomization.
  • Have a serum testosterone level lower than 1.7 nmol/L (or 50 ng/dL), indicating effective hormone suppression.
  • If you received palliative radiotherapy (radiation to relieve symptoms), it must have been finished at least 4 weeks earlier for wide‑field treatment or at least 2 weeks earlier for limited‑field treatment.
  • Provide a formalin‑fixed paraffin‑embedded (FFPE) tumor tissue sample and a blood sample for circulating tumor DNA (ctDNA) testing.

Who cannot join the trial?

12 criteria

  • Allergic reaction (hypersensitivity) to saruparib, the ARPI medicine, any of their inactive ingredients, or if the drug’s label says you should not take it.
  • Had a major surgery or a serious injury within the past 4 weeks, or you are expected to need a major surgery while in the study.
  • Switched to a different ARPI (a type of hormone therapy for prostate cancer) because the cancer got worse; this disqualifies you.
  • Any previous treatment with a PARPi (a drug that blocks DNA repair) or with platinum chemotherapy (cancer drugs that contain platinum).
  • History of severe low blood counts (cytopenia) lasting more than 2 weeks, such as very low white blood cells (ANC < 0.5 × 10⁹/L) or low platelets (<50 × 10⁹/L).
  • Known tendency to bleed, such as an active peptic ulcer (stomach ulcer), a bleeding stroke (hemorrhagic stroke) within the last 6 months, or severe eye disease from diabetes (proliferative diabetic retinopathy).
  • Spinal cord compression or cancer that has spread to the brain (brain metastases) unless it is not causing symptoms and is stable.
  • History of MDS/AML (blood cancers called myelodysplastic syndrome or acute myeloid leukemia) or signs that suggest these conditions.
  • History of another primary malignancy (another main cancer), except for certain allowed exceptions.
  • Any chronic stomach or intestinal problems (gastrointestinal diseases) or inability to swallow the study drug that would prevent it from being absorbed.
  • History of seizure or anything that makes seizures likely, including loss of consciousness or a brief stroke-like event (transient ischemic attack) within the past 12 months.
  • Serious, uncontrolled medical disorder, non‑cancer systemic disease, or an active infection that is not under control.
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Investigated drugs

  • Leuprorelin acetate

    is an injection that lowers the amount of testosterone in the body. In this study it is given to help keep hormone levels low while other treatments are tested.

  • Relugolix

    is an oral pill that blocks the signals that tell the body to make testosterone. It is used as part of the background hormone‑lowering therapy in the trial.

  • Goserelin

    is an injectable medication that also reduces testosterone production. It works together with the other hormone‑blocking drugs to keep hormone levels low.

  • Prednisolone

    is a steroid taken by mouth that helps control inflammation and can reduce side‑effects from cancer treatments. It is included as a supportive medication in the study.

  • Prednisone

    is another oral steroid similar to prednisolone. It is used to manage inflammation and support patients during the trial.

  • Degarelix acetate

    is an injectable drug that quickly lowers testosterone by blocking the hormone’s release. It is part of the background hormone therapy given to participants.

What is already known about the treatment

  • Leuprorelin acetate

    Leuprorelin acetate is given as an injection that is placed under the skin or into a muscle, where it slowly releases the drug. It is a well‑known GnRH (gonadotropin‑releasing hormone) agonist that lowers testosterone levels by telling the body to stop making it. It is used mainly to treat prostate cancer that depends on hormones, as well as some other hormone‑sensitive conditions. It works by continuously stimulating the GnRH receptor, which eventually shuts down the hormone signals that lead to testosterone production.

  • Saruparib

    Saruparib is taken as an oral tablet that is swallowed with water. It is an experimental drug that is currently being studied in clinical trials for prostate cancer. It belongs to a new class of medicines that aim to block the activity of the androgen receptor, a protein that helps prostate cancer cells grow. By binding to this receptor, saruparib tries to stop the signal that tells the cancer cells to multiply.

  • Enzalutamide (Xtandi)

    Enzalutamide comes as a film‑coated oral tablet that is swallowed whole. It is an approved androgen receptor inhibitor that is already used to treat advanced prostate cancer. It works by attaching to the androgen receptor inside cells and preventing testosterone from activating it. This stops the growth signal that drives prostate cancer cells.

  • Abiraterone acetate (Zytiga)

    Abiraterone acetate is provided as a film‑coated oral tablet taken by mouth, usually with a steroid to reduce side effects. It is an approved medicine for metastatic prostate cancer and is listed in medical guidelines. The drug blocks an enzyme called CYP17, which is needed for the body to make testosterone and other hormones. By lowering hormone production, it helps slow the growth of prostate cancer.

  • Darolutamide (BAY 1841788, Nubeqa)

    Darolutamide is supplied as a film‑coated oral tablet that patients swallow with water. It is an approved androgen receptor inhibitor used for non‑metastatic and metastatic prostate cancer. The medication binds to the androgen receptor and stops testosterone from turning the receptor on. This blocks the signal that makes prostate cancer cells grow.

  • Relugolix

    Relugolix is taken as an oral tablet that is swallowed whole. It is a newer GnRH antagonist that has been approved for treating advanced prostate cancer. Unlike agonists, it blocks the GnRH receptor directly, causing a rapid drop in testosterone levels. The fast reduction of testosterone helps control the spread of hormone‑sensitive prostate cancer.

Investigated diseases

Metastatic hormone-sensitive prostate cancer (mHSPC) - This is prostate cancer that has spread beyond the prostate gland to other parts of the body while still responding to hormonal control of testosterone. The cancer commonly involves bones, lymph nodes, or other soft tissues, leading to an increasing number of tumor sites. As the disease advances, cancer cells continue to grow despite low testosterone levels, eventually becoming less dependent on hormones. Progression is tracked by imaging studies and rising prostate‑specific antigen (PSA) levels.
Trial detailsLast updated 28 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526275-38-00Protocol codeD972DC00001Estimated enrolment1 165 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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