“A randomized phase II trial to evaluate the antitumor activity of Enzalutamide and Talazoparib (PF-06944076) for the treatment of metastatic hormone-naïve prostate cancer”

Conditions

Metastatic hormone–naïve prostate cancer (mHNPC)

Brief summary

PSA-CR defined as the percentage of patients with PSA < 0.2 ng/mL at month 12 of therapy.

Detailed description

Rate of PSA complete response (CR) at any time point and at month 7 (<0.2 ng/mL), PSA response (< 4ng/ml) at 7 and 12 months, PSAprogression-free survival (PSA-PFS) based on Prostate Cancer Working Group 3 (PCWG3) criteria (PSA ≥ 25% and ≥ 2 ng/mL from nadir confirmed by a second value obtained 3 or more weeks later),, radiologic PFS (rPFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1, time to castration resistance (TTCR), based on PSA-PFS and RECIST rPFS, and overall survival (OS), Incidence of adverse events (AEs), incidence of prespecified AEs as per National Cancer Insitute’s Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, change from baseline in targeted vital signs, and change from baseline in targeted clinical laboratory test results.

Related papers

No related papers found yet.

Interventions

DRUGTalzenna 0.25 mg hard capsules

DRUGTalzenna 0.1 mg hard capsules

DRUGXtandi - 40 mg film-coated tablets

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PSA-CR defined as the percentage of patients with PSA < 0.2 ng/mL at month 12 of therapy.	—

Secondary

Measure	Time frame
Rate of PSA complete response (CR) at any time point and at month 7 (<0.2 ng/mL), PSA response (< 4ng/ml) at 7 and 12 months, PSAprogression-free survival (PSA-PFS) based on Prostate Cancer Working Group 3 (PCWG3) criteria (PSA ≥ 25% and ≥ 2 ng/mL from nadir confirmed by a second value obtained 3 or more weeks later),, radiologic PFS (rPFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1, time to castration resistance (TTCR), based on PSA-PFS and RECIST rPFS, and overall survival (OS), Incidence of adverse events (AEs), incidence of prespecified AEs as per National Cancer Insitute’s Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, change from baseline in targeted vital signs, and change from baseline in targeted clinical laboratory test results.	—

Measure

Time frame

Rate of PSA complete response (CR) at any time point and at month 7 (<0.2 ng/mL), PSA response (< 4ng/ml) at 7 and 12 months, PSAprogression-free survival (PSA-PFS) based on Prostate Cancer Working Group 3 (PCWG3) criteria (PSA ≥ 25% and ≥ 2 ng/mL from nadir confirmed by a second value obtained 3 or more weeks later),, radiologic PFS (rPFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1, time to castration resistance (TTCR), based on PSA-PFS and RECIST rPFS, and overall survival (OS), Incidence of adverse events (AEs), incidence of prespecified AEs as per National Cancer Insitute’s Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, change from baseline in targeted vital signs, and change from baseline in targeted clinical laboratory test results.

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Countries

Spain

Outcome results

None listed