| TITRE |
(EN) 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 |
| PROTOCOLE ID |
EvoPAR-Prostate01 |
| CLINICAL TRIAL.gov ID |
NCT06120491 |
| TYPE(S) DE CANCER |
Prostate |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Ramy Saleh
|
| COORDONATEUR(RICE) |
Rodrigo Skowronski
rodrigo.skowronski@muhc.mcgill.ca
514-934-1934 poste 36275
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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.
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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
|
