Klinische Studie

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)(EvoPAR-Prostate01)Randomized,2-cohort,Double-blind,Placebo-controlled,Phase 3 Study of AZD5305 in Combi + Physician’s Choice New Hormonal Agents in Patients + HRRm and non-HRRm mCSPC
Krankheitsentität(en) Prostata
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien1. 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. 2. Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion (defined as 1 lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment with CT and/or MRI. Participants with metastatic disease identified by PSMA-PET only, will not be eligible. Participants with disease limited to regional pelvic lymph nodes only are not eligible. 3. Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and < 4 months prior to randomisation with no radiographic evidence of disease progression or rising PSA levels prior to first day of dosing. Participant must remain on ADT throughout the study and be a candidate for treatment with an NHA. Combination with first generation AR antagonists to counter testosterone flare is permitted until randomisation. 4. ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation. 5. Minimum life expectancy of 6 months.
Wesentliche Ausschlusskriterien1. Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). Specific screening for MDS/AML is not required. 2. Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy). 3. Any history of persisting (> 2 weeks) severe cytopenia due to any cause (eg, absolute neutrophil count < 0.5 × 109/L or platelets < 50 × 109/L). 4. 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. 5. History of another primary malignancy, with the following exceptions:  - Adequately resected non-melanoma skin cancer.  - Curatively treated in situ disease.  - Malignancy treated with curative intent ≥ 3 years before the first dose of study intervention, and with no known active disease during the intervening time period.
Statusin Vorbereitung
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de
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