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JOURNAL ONKOLOGIE – STUDIE
EvoPAR-PR01

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Rekrutierend

NCT-Nummer:
NCT06120491

Studienbeginn:
November 2023

Letztes Update:
26.04.2024

Wirkstoff:
Placebo, abiraterone acetate, darolutamide, Enzalutamide, Saruparib

Indikation (Clinical Trials):
Prostatic Neoplasms, Hypersensitivity

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Studienleiter

Kim Nguyen Chi, MD
Principal Investigator
BC Cancer, Canada
Arun Azad, MD
Principal Investigator
Peter MacCallum Cancer Centre, Australia

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen

Studienlocations
(3 von 395)

Research Site
51465 Bergisch Gladbach
(Nordrhein-Westfalen)
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10117 Berlin
(Berlin)
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53113 Bonn
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38126 Braunschweig
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01307 Dresden
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47169 Duisburg
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91054 Erlangen
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60590 Frankfurt am Main
(Hessen)
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60488 Frankfurt
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79106 Freiburg
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37075 Göttingen
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20246 Hamburg
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69120 Heidelberg
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66421 Homburg
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50968 Köln
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68167 Mannheim
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35043 Marburg
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40822 Mettmann
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81675 München
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48149 Münster
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72622 Nürtingen
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26133 Oldenburg
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93053 Regensburg
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70176 Stuttgart
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54292 Trier
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72076 Tübingen
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89081 Ulm
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85224 Chandler
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84106 Salt Lake City
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22031 Fairfax
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99216 Spokane Valley
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3500 Krems an der Donau
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80810-050 Curitiba
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91350-200 Porto Alegre
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22775-001 Rio de Janeiro
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65060-645 Sao Luis
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01323-903 Sao Paulo
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05652000 São Paulo
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G7H 5H6 Chicoutimi
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15002 Aurillac Cedex
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33000 Bordeaux Cedex
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41076 Caen Cedex 5
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63011 Clermont Ferrand
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69495 Pierre Bénite
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86021 Poitiers Cedex
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35033 Rennes Cedex 9
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54519 Vandoeuvre les Nancy
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4400 Nyíregyháza
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811-1347 Fukuoka-shi
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036-8563 Hirosaki-shi
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920-8641 Kanazawa-shi
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634-8522 Kashihara-shi
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350-8550 Kawagoe-shi
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371-8811 Maebashi-shi
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466-8560 Nagoya-shi
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13620 Seongnam-si
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81100 Johor Bahru
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59100 Kuala Lumpur
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1066 CX Amsterdam
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Studien-Informationen

Detailed 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 + physicians choice NHA.

Ein-/Ausschlusskriterien

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

- 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 arrythmia 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

Studien-Rationale

Primary outcome:

1. 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 outcome:

1. 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.

2. Second Progression-Free Survival (PFS2) (Time Frame - up to approximately 90 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.

3. Time to First Subsequent Therapy or Death (TFST) (Time Frame - up to approximately 90 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.

4. Symptomatic Skeletal Event-Free Survival (SSE-FS) (Time Frame - up to approximately 90 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.

5. Time to the First Castration-Resistant Event (TTCR) (Time Frame - up to approximately 90 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).

6. Time to Pain Progression (TTPP) (Time Frame - up to approximately 90 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.

7. Time To Deterioration in Urinary Symptoms (TTDUS) (Time Frame - up to approximately 90 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.

8. Time to Deterioration in Fatigue (TTDF) (Time Frame - up to approximately 90 months):
TTDF is defined as the time from randomisation to deterioration in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7A scores.

9. Time to Deterioration in Physical Function (TTDPF) (Time Frame - up to approximately 90 months):
TTDPF is defined as the time from randomisation to deterioration in PROMIS Physical Function Short Form 8C scores.

10. Health-related Quality of Life (HrQoL) (Time Frame - up to approximately 90 months):
Change from baseline in BPI-SF worst pain score, pain severity, and interference domain scores.

11. BRCA and other HRR gene mutation status. (Time Frame - at screening)

12. Plasma concentrations of AZD5305 (Time Frame - up to approximately 90 months)

13. 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 90 months):
Samples will be tested by a CDx to certify consistency with assays used in the study.

14. PSA (prostate-specific antigen) undetectable rate at 6, 12 months (Time Frame - up to approximately 90 months):
proportion of participants with undetectable PSA (< 0.2 ng/mL) for those with PSA ≥ 0.2 ng/mL at baseline

Studien-Arme

  • Experimental: Arm 1: Saruparib (AZD5305) + Physician's Choice NHA
    Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
  • Placebo Comparator: Arm 2: Placebo + Physician's Choice NHA
    Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)

Geprüfte Regime

  • Saruparib (AZD5305):
    Oral
  • Placebo:
    Oral
  • Abiraterone Acetate (Zytiga):
    Oral
  • Darolutamide (Nubequa):
    Oral
  • Enzalutamide (Xtandi):
    Oral

Quelle: ClinicalTrials.gov


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"Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents"

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