Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Metastatic Castration-Sensitive Prostate Cancer
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 18 years - 130 years
- Sex eligible
- Male
- Healthy volunteers
- Not accepted
- Participants
- 1898 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
Read the full description
Approximately 1800 adult participants with mCSPC will be assigned to one of two cohorts (550 HRRm and 1250 non-HRRm) and randomized in a 1:1 ratio to receive either Saruparib (AZD5305) with NHA or placebo with NHA. They will receive their assigned treatment and regular tumor evaluation scans until disease progression, or until treatment is stopped for another reason.
All patients will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of Saruparib (AZD5305) + physicians choice NHA.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Male ≥ 18 years of age.
- Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
- Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
- Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and \< 4 months prior to randomisation.
- ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
- Provision of FFPE tumour tissue sample and blood sample (for ctDNA).
- Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.
- Adequate organ and bone marrow function as described in study protocol.
- Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
- Participants must use a condom 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 MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no clinical MDS/AML suspicion, no specific screening for MDS/AML (by BM/bone biopsy) is required.
- Participants with any known predisposition to bleeding.
- Any history of persisting (\> 2 weeks) severe cytopenia.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
- History of another primary malignancy, with exceptions.
- Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
- Cardiac criteria, including history of arrhythmia and cardiovascular disease.
- Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions.
- Prior treatment within 14 days with blood product support or growth factor support.
- Participants who are unevaluable for both bone and soft tissue progression.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
Arm 1: Saruparib (AZD5305) + Physician's Choice NHA
Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Drug: Saruparib · Drug: Abiraterone Acetate · Drug: Darolutamide · Drug: Enzalutamide
Arm 2: Placebo + Physician's Choice NHA
Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Drug: Placebo · Drug: Abiraterone Acetate · Drug: Darolutamide · Drug: Enzalutamide
Saruparib DRUG
Oral
Placebo DRUG
Oral
Abiraterone Acetate DRUG
Oral
Darolutamide DRUG
Oral
Enzalutamide DRUG
Oral
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Radiographic Progression-Free Survival (rPFS)
Time frame: Up to approximately 50 months
rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.
Secondary measures
Overall Survival (OS)
Time frame: Up to approximately 90 months
OS is defined as the time from randomisation until the date of death due to any cause.
Second Progression-Free Survival (PFS2)
Time frame: Up to approximately 50 months
Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression (defined as radiographic progression, clinical progression, or PSA progression) after initiation of first subsequent treatment following the initial investigator-assessed progression or death.
Time to First Subsequent Therapy or Death (TFST)
Time frame: Up to approximately 50 months
TFST is defined as the time from randomisation to the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause.
Symptomatic Skeletal Event-Free Survival (SSE-FS)
Time frame: Up to approximately 50 months
SSE-FS is defined as the time from randomisation to the earliest of the following:
- Use of radiation therapy to prevent or relieve skeletal symptoms.
- Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).
- Occurrence of spinal cord compression.
- Orthopaedic surgical intervention for bone metastasis.
- Death due to any cause.
Time to the First Castration-Resistant Event (TTCR)
Time frame: Up to approximately 50 months
TTCR is defined as the time from randomisation to the first castration resistant event (radiographic disease progression per RECIST 1.1 \[soft tissue\] and/or PCWG3 criteria \[bone\], PSA progression per PCWG3, or SSE, PSA progression per PCWG3, or SSE), whichever occurs first, with castrate levels of testosterone (below 50 ng/dL).
Time to Pain Progression (TTPP)
Time frame: Up to approximately 50 months
TTPP is defined as the time from randomisation to clinically meaningful pain progression based on a 2-point increase from baseline in the Brief Pain Inventory - Short Form (BPI-SF) Item 3 'worst pain in 24 hours' score and/or initiation of/increase in opioid analgesic use.
Time To Deterioration in Urinary Symptoms (TTDUS)
Time frame: Up to approximately 50 months
TTDUS is defined as the time from randomisation to deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Prostate Questionnaire (Urinary Symptoms) (QLQPR25 \[US\]) subscale scores.
Time to Deterioration in Physical Function (TTDPF)
Time frame: Up to approximately 50 months
TTDPF is defined as the time from randomisation to deterioration in PROMIS Physical Function Short Form 8C scores, or death due to any cause.
Health-related Quality of Life (HrQoL)
Time frame: Up to approximately 50 months
Change from baseline in BPI-SF worst pain score, pain severity, and interference domain scores.
BRCA, other HRR gene mutation and HRD status
Time frame: At screening
Not reported in this registry record.
Plasma concentrations of AZD5305
Time frame: Up to approximately 10 months
Not reported in this registry record.
Samples will be used to develop complementary or companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
Time frame: Up to approximately 50 months
Samples will be tested by a CDx to certify consistency with assays used in the study.
Assessment of PSA (prostate-specific antigen) in participants in mCSPC
Time frame: Up to approximately 50 months
proportion of participants achieving a \>= 50% or \>=90% decrease in PSA from baseline; proportion of participants with undetectable PSA (\< 0.2 ng/mL); time to PSA progression
Other measures
Number of TEAEs (treatment emergent adverse events), SAEs (serious adverse events), and AEs (adverse events) leading to dose modifications
Time frame: Up to approximately 50 months
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (322)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
322 locations
Research SiteChandler, Arizona, United StatesStatus unknown
Research SiteGilbert, Arizona, United StatesStatus unknown
Research SitePhoenix, Arizona, United StatesStatus unknown
Research SiteTucson, Arizona, United StatesStatus unknown
Research SiteLittle Rock, Arkansas, United StatesStatus unknown
Research SiteSpringdale, Arkansas, United StatesStatus unknown
Research SiteBakersfield, California, United StatesStatus unknown
Research SiteFountain Valley, California, United StatesStatus unknown
Research SiteFullerton, California, United StatesStatus unknown
Research SiteLos Angeles, California, United StatesStatus unknown
Research SiteMontebello, California, United StatesStatus unknown
Research SiteSan Francisco, California, United StatesStatus unknown
Research SiteSanta Barbara, California, United StatesStatus unknown
Research SiteSanta Monica, California, United StatesStatus unknown
Research SiteSanta Rosa, California, United StatesStatus unknown
Research SiteGolden, Colorado, United StatesStatus unknown
Research SiteLakewood, Colorado, United StatesStatus unknown
Research SiteNew Haven, Connecticut, United StatesStatus unknown
Research SiteAtlanta, Georgia, United StatesStatus unknown
Research SiteGlenview, Illinois, United StatesStatus unknown
Research SiteLake Barrington, Illinois, United StatesStatus unknown
Research SiteFort Wayne, Indiana, United StatesStatus unknown
Research SiteIndianapolis, Indiana, United StatesStatus unknown
Research SiteWestwood, Kansas, United StatesStatus unknown
Research SiteShreveport, Louisiana, United StatesStatus unknown
Research SiteScarborough, Maine, United StatesStatus unknown
Research SiteBaltimore, Maryland, United StatesStatus unknown
Research SiteBaltimore, Maryland, United StatesStatus unknown
Research SiteBethesda, Maryland, United StatesStatus unknown
Research SiteTowson, Maryland, United StatesStatus unknown
Research SiteUpper Marlboro, Maryland, United StatesStatus unknown
Research SiteGrand Rapids, Michigan, United StatesStatus unknown
Research SiteTroy, Michigan, United StatesStatus unknown
Research SiteRochester, Minnesota, United StatesStatus unknown
Research SiteBozeman, Montana, United StatesStatus unknown
Research SiteLas Vegas, Nevada, United StatesStatus unknown
Research SiteLas Vegas, Nevada, United StatesStatus unknown
Research SiteCamden, New Jersey, United StatesStatus unknown
Research SiteAlbuquerque, New Mexico, United StatesStatus unknown
Research SiteEast Syracuse, New York, United StatesStatus unknown
Research SiteNew Hyde Park, New York, United StatesStatus unknown
Research SiteNew York, New York, United StatesStatus unknown
Research SiteSyracuse, New York, United StatesStatus unknown
Research SiteDurham, North Carolina, United StatesStatus unknown
Research SiteCincinnati, Ohio, United StatesStatus unknown
Research SiteCincinnati, Ohio, United StatesStatus unknown
Research SiteCleveland, Ohio, United StatesStatus unknown
Research SiteCleveland, Ohio, United StatesStatus unknown
Research SiteColumbus, Ohio, United StatesStatus unknown
Research SitePortland, Oregon, United StatesStatus unknown
Research SiteBala-Cynwyd, Pennsylvania, United StatesStatus unknown
Research SitePhiladelphia, Pennsylvania, United StatesStatus unknown
Research SitePittsburgh, Pennsylvania, United StatesStatus unknown
Research SiteProvidence, Rhode Island, United StatesStatus unknown
Research SiteMyrtle Beach, South Carolina, United StatesStatus unknown
Research SiteNorth Charleston, South Carolina, United StatesStatus unknown
Research SiteSioux Falls, South Dakota, United StatesStatus unknown
Research SiteGermantown, Tennessee, United StatesStatus unknown
Research SiteNashville, Tennessee, United StatesStatus unknown
Research SiteDallas, Texas, United StatesStatus unknown
Research SiteHouston, Texas, United StatesStatus unknown
Research SiteSan Antonio, Texas, United StatesStatus unknown
Research SiteSugar Land, Texas, United StatesStatus unknown
Research SiteTyler, Texas, United StatesStatus unknown
Research SiteWichita Falls, Texas, United StatesStatus unknown
Research SiteSalt Lake City, Utah, United StatesStatus unknown
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Research SiteSt. George, Utah, United StatesStatus unknown
Research SiteFairfax, Virginia, United StatesStatus unknown
Research SiteSpokane, Washington, United StatesStatus unknown
Research SiteTacoma, Washington, United StatesStatus unknown
Research SiteChermside, AustraliaStatus unknown
Research SiteDarlinghurst, AustraliaStatus unknown
Research SiteHyde Park, AustraliaStatus unknown
Research SiteKurralta Park, AustraliaStatus unknown
Research SiteMelbourne, AustraliaStatus unknown
Research SiteSouth Brisbane, AustraliaStatus unknown
Research SiteGraz, AustriaStatus unknown
Research SiteInnsbruck, AustriaStatus unknown
Research SiteKrems, AustriaStatus unknown
Research SiteLinz, AustriaStatus unknown
Research SiteVienna, AustriaStatus unknown
Research SiteVienna, AustriaStatus unknown
Research SiteGhent, BelgiumStatus unknown
Research SiteKortrijk, BelgiumStatus unknown
Research SiteLeuven, BelgiumStatus unknown
Research SiteCuritiba, BrazilStatus unknown
Research SitePelotas, BrazilStatus unknown
Research SitePorto Alegre, BrazilStatus unknown
Research SiteRio de Janeiro, BrazilStatus unknown
Research SiteSalvador, BrazilStatus unknown
Research SiteSão Paulo, BrazilStatus unknown
Research SiteSão Paulo, BrazilStatus unknown
Research SiteSão Paulo, BrazilStatus unknown
Research SiteCalgary, Alberta, CanadaStatus unknown
Research SiteCalgary, Alberta, CanadaStatus unknown
Research SiteAbbotsford British Columbia, British Columbia, CanadaStatus unknown
Research SiteAbbotsford British Columbia, British Columbia, CanadaStatus unknown
Research SiteKelowna, British Columbia, CanadaStatus unknown
Research SiteVancouver, British Columbia, CanadaStatus unknown
Research SiteKingston, Ontario, CanadaStatus unknown
Research SiteMississauga, Ontario, CanadaStatus unknown
Research SiteNewmarket, Ontario, CanadaStatus unknown
Research SiteOttawa, Ontario, CanadaStatus unknown
Research SiteToronto, Ontario, CanadaStatus unknown
Research SiteToronto, Ontario, CanadaStatus unknown
Research SiteChicoutimi, Quebec, CanadaStatus unknown
Research SiteGreenfield Park, Quebec, CanadaStatus unknown
Research SiteMontreal, Quebec, CanadaStatus unknown
Research SiteMontreal, Quebec, CanadaStatus unknown
Research SiteMontreal, Quebec, CanadaStatus unknown
Research SiteQuébec, Quebec, CanadaStatus unknown
Research SiteSaskatoon, Saskatchewan, CanadaStatus unknown
Research SiteConcepción, ChileStatus unknown
Research SiteLa Serena, ChileStatus unknown
Research SiteSantiago, ChileStatus unknown
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Research SiteTemuco, ChileStatus unknown
Research SiteViña del Mar, ChileStatus unknown
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Research SiteChangsha, ChinaStatus unknown
Research SiteChengdu, ChinaStatus unknown
Research SiteChongqing, ChinaStatus unknown
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Research SiteDongguan, ChinaStatus unknown
Research SiteGuangzhou, ChinaStatus unknown
Research SiteGuilin, ChinaStatus unknown
Research SiteHangzhou, ChinaStatus unknown
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Research SiteHarbin, ChinaStatus unknown
Research SiteJiaxing, ChinaStatus unknown
Research SiteJinan, ChinaStatus unknown
Research SiteLanzhou, ChinaStatus unknown
Research SiteNanchang, ChinaStatus unknown
Research SiteNanchang, ChinaStatus unknown
Research SiteNanjing, ChinaStatus unknown
Research SiteNantong, ChinaStatus unknown
Research SiteNingbo, ChinaStatus unknown
Research SiteShandong, ChinaStatus unknown
Research SiteShanghai, ChinaStatus unknown
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Research SiteShenyang, ChinaStatus unknown
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Research SiteSuining, ChinaStatus unknown
Research SiteTaiyuan, ChinaStatus unknown
Research SiteTianjin, ChinaStatus unknown
Research SiteWenzhou, ChinaStatus unknown
Research SiteWuhan, ChinaStatus unknown
Research SiteXi'an, ChinaStatus unknown
Research SiteYantai, ChinaStatus unknown
Research SiteZhengzhou, ChinaStatus unknown
Research SiteAngers, FranceStatus unknown
Research SiteBayonne, FranceStatus unknown
Research SiteBordeaux, FranceStatus unknown
Research SiteCaen, FranceStatus unknown
Research SiteClermont-Ferrand, FranceStatus unknown
Research SiteCréteil, FranceStatus unknown
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Research SiteMontpellier, FranceStatus unknown
Research SiteNice, FranceStatus unknown
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Research SitePierre-Bénite, FranceStatus unknown
Research SitePoitiers, FranceStatus unknown
Research SiteQuimper, FranceStatus unknown
Research SiteRennes, FranceStatus unknown
Research SiteStrasbourg, FranceStatus unknown
Research SiteTours, FranceStatus unknown
Research SiteVandœuvre-lès-Nancy, FranceStatus unknown
Research SiteBergisch Gladbach, GermanyStatus unknown
Research SiteBerlin, GermanyStatus unknown
Research SiteBraunschweig, GermanyStatus unknown
Research SiteCologne, GermanyStatus unknown
Research SiteDresden, GermanyStatus unknown
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Research SiteMettmann, GermanyStatus unknown
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Research SiteTrier, GermanyStatus unknown
Research SiteTübingen, GermanyStatus unknown
Research SiteUlm, GermanyStatus unknown
Research SiteBudapest, HungaryStatus unknown
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Research SiteDebrecen, HungaryStatus unknown
Research SiteMiskolc, HungaryStatus unknown
Research SiteSzeged, HungaryStatus unknown
Research SiteBangalore, IndiaStatus unknown
Research SiteCalicut, IndiaStatus unknown
Research SiteKanpur, IndiaStatus unknown
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Research SiteNagpur, IndiaStatus unknown
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Research SitePune, IndiaStatus unknown
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Research SiteVaranasi, IndiaStatus unknown
Research SiteBari, ItalyStatus unknown
Research SiteGenoa, ItalyStatus unknown
Research SiteMeldola, ItalyStatus unknown
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Research SiteNaples, ItalyStatus unknown
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Research SiteRozzano, ItalyStatus unknown
Research SiteTerni, ItalyStatus unknown
Research SiteTrento, ItalyStatus unknown
Research SiteChiba, JapanStatus unknown
Research SiteFukuoka, JapanStatus unknown
Research SiteFukuoka, JapanStatus unknown
Research SiteHirakata-shi, JapanStatus unknown
Research SiteHirosaki-shi, JapanStatus unknown
Research SiteKanazawa, JapanStatus unknown
Research SiteKashihara-shi, JapanStatus unknown
Research SiteKawagoe-shi, JapanStatus unknown
Research SiteKisarazu-shi, JapanStatus unknown
Research SiteKita-gun, JapanStatus unknown
Research SiteKobe, JapanStatus unknown
Research SiteKumamoto, JapanStatus unknown
Research SiteKyoto, JapanStatus unknown
Research SiteMaebashi, JapanStatus unknown
Research SiteNagano, JapanStatus unknown
Research SiteNagasaki, JapanStatus unknown
Research SiteNagoya, JapanStatus unknown
Research SiteNagoya, JapanStatus unknown
Research SiteOsaka, JapanStatus unknown
Research SiteOsakasayama-shi, JapanStatus unknown
Research SiteSagamihara-shi, JapanStatus unknown
Research SiteSakura-shi, JapanStatus unknown
Research SiteSapporo, JapanStatus unknown
Research SiteShiwa-gun, JapanStatus unknown
Research SiteSuita-shi, JapanStatus unknown
Research SiteTsu, JapanStatus unknown
Research SiteYokohama, JapanStatus unknown
Research SiteYufu-shi, JapanStatus unknown
Research SiteGeorge Town, MalaysiaStatus unknown
Research SiteJohor Bahru, MalaysiaStatus unknown
Research SiteKota Kinabalu, MalaysiaStatus unknown
Research SiteKuala Lumpur, MalaysiaStatus unknown
Research SiteKuala Lumpur, MalaysiaStatus unknown
Research SiteKuching, MalaysiaStatus unknown
Research SiteAmsterdam, NetherlandsStatus unknown
Research SiteHilversum, NetherlandsStatus unknown
Research SiteNijmegen, NetherlandsStatus unknown
Research SiteBellavista, PeruStatus unknown
Research SiteLima, PeruStatus unknown
Research SiteLima, PeruStatus unknown
Research SiteLima, PeruStatus unknown
Research SiteLima, PeruStatus unknown
Research SiteLima, PeruStatus unknown
Research SiteBydgoszcz, PolandStatus unknown
Research SiteKoszalin, PolandStatus unknown
Research SitePoznan, PolandStatus unknown
Research SiteRzeszów, PolandStatus unknown
Research SiteWarsaw, PolandStatus unknown
Research SiteWroclaw, PolandStatus unknown
Research SiteDaejeon, South KoreaStatus unknown
Research SiteSeongnam-si, South KoreaStatus unknown
Research SiteSeoul, South KoreaStatus unknown
Research SiteSeoul, South KoreaStatus unknown
Research SiteSeoul, South KoreaStatus unknown
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Research SiteSeoul, South KoreaStatus unknown
Research SiteSuwon, South KoreaStatus unknown
Research SiteBarcelona, SpainStatus unknown
Research SiteCórdoba, SpainStatus unknown
Research SiteL'Hospitalet de Llobregat, SpainStatus unknown
Research SiteLugo, SpainStatus unknown
Research SiteMadrid, SpainStatus unknown
Research SiteMadrid, SpainStatus unknown
Research SiteMadrid, SpainStatus unknown
Research SiteSabadell, SpainStatus unknown
Research SiteValencia, SpainStatus unknown
Research SiteKaohsiung City, TaiwanStatus unknown
Research SiteKaohsiung City, TaiwanStatus unknown
Research SiteTaichung, TaiwanStatus unknown
Research SiteTaichung, TaiwanStatus unknown
Research SiteTaoyuan, TaiwanStatus unknown
Research SiteYung Kang City, TaiwanStatus unknown
Research SiteBangkok, ThailandStatus unknown
Research SiteBangkok, ThailandStatus unknown
Research SiteBangkok, ThailandStatus unknown
Research SiteChiang Mai, ThailandStatus unknown
Research SiteKhlong Luang, ThailandStatus unknown
Research SiteSongkhla, ThailandStatus unknown
Research SiteAnkara, Turkey (Türkiye)Status unknown
Research SiteAnkara, Turkey (Türkiye)Status unknown
Research SiteBornova-Izmir, Turkey (Türkiye)Status unknown
Research SiteCordaleo, Turkey (Türkiye)Status unknown
Research SiteFatih-Istanbul, Turkey (Türkiye)Status unknown
Research SiteIstanbul, Turkey (Türkiye)Status unknown
Research SiteAberdeen, United KingdomStatus unknown
Research SiteBirmingham, United KingdomStatus unknown
Research SiteCambridge, United KingdomStatus unknown
Research SiteGlasgow, United KingdomStatus unknown
Research SiteGuildford, United KingdomStatus unknown
Research SiteLondon, United KingdomStatus unknown
Research SiteLondon, United KingdomStatus unknown
Research SiteManchester, United KingdomStatus unknown
Research SiteNewcastle upon Tyne, United KingdomStatus unknown
Research SiteOxford, United KingdomStatus unknown
Research SitePlymouth, United KingdomStatus unknown
Research SitePreston, United KingdomStatus unknown
Research SiteTruro, United KingdomStatus unknown
Study team and timeline
- Lead sponsor
- AstraZeneca
- Study start
- Nov 21, 2023 Actual
- Primary completion
- Sep 30, 2027 Estimated
- Study completion
- Apr 30, 2031 Estimated
- First posted
- Nov 7, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026