Informations générales (source: ClinicalTrials.gov)
A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
août 2025
avril 2036
29 mai 2026
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to
placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT)
regimen by assessment of metastases-free survival in participants with high-risk and very
high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation
(BRCAm).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Mario TERLIZZI | 29/05/2026 15:50:04 | Contacter | ||
Critères
Homme
- Male participants with a histologically documented diagnosis of prostate
adenocarcinoma.
- Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate
cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.
- Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.
- Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for
enrolment.
- Participants required to have a computed tomography (CT) or magnetic resonance
imaging (MRI) and a bone scan following the completion of their planned RT. This
screening scan must confirm no evidence of disease or evidence of disease confined
to the pelvis (M0).
- Participants required to have a prostate-specific membrane antigen-positron emission
tomography (PSMA-PET) following the completion of their planned RT. This screening
scan must confirm no evidence of disease or evidence of disease confined to the
pelvis (M0).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no
deterioration over the 2 weeks prior to randomization.
- Minimum life expectancy of 12 months.
- Adequate organ and bone marrow function as described in study protocol.
- All participants will have received either primary or salvage RT. Participants must
be eligible for randomisation within 10 months of initial diagnosis (de novo or
BCR). Radiotherapy administered to the prostate (± pelvis) either in the primary or
salvage setting must be delivered with curative intent. Use of metastases-directed
therapy, as part of the RT radiation plan, is permitted as localised RT treatment
for a metastatic lesion(s) outside the pelvis.
- All participants will have received a planned regimen of ADT with a gonadotropin
releasing hormone (GnRH) analogue.
- Participants must not father children or donate sperm from signing informed consent
form (ICF), during the study intervention and for 6 months after the last dose of
study intervention.
- Participants must use a condom (with spermicide - where permitted) from signing ICF,
during study intervention, and for 6 months after the last dose of study drug, with
all sexual partners.
Exclusion Criteria:
- Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid
leukemia (AML) or with features suggestive of MDS/AML.
- Participants with any known predisposition to bleeding [e.g., active peptic
ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic
retinopathy].
- Any history of persisting (> 2 weeks) severe cytopenia due to any cause.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the formulated product or previous significant bowel resection that would
preclude adequate absorption of saruparib and/or abiraterone.
- History of another primary malignancy, with exceptions.
- Persistent toxicities [Common Terminology Criteria for Adverse Events (CTCAE) Grade
≥ 2] caused by previous anticancer therapy.
- Cardiac criteria, including history of arrhythmia and cardiovascular disease.
- Evidence of active and uncontrolled hepatitis B and/or hepatitis C.
- Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.
- Active tuberculosis infection.
- Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with
a poly (ADP-ribose) polymerase (PARP) inhibitor.
- Prior treatment within 14 days with blood product support or growth factor support.
- Concomitant use of strong inducers and inhibitors of CYP3A4 (applies to saruparib
and abiraterone) or herbal supplements within 21 days or at least 5 half-lives
(whichever is longer), of randomization.
- Concomitant use of drugs that are known to prolong QT and have a known risk of
Torsades de Pointes (TdP).
- Participants with a known hypersensitivity to saruparib or any excipients of these
products.