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A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate or Darolutamide

ConditionsProstate Cancer (Adenocarcinoma)mCRPC (Metastatic Castration-resistant Prostate Cancer)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorProstate Cancer Clinical Trials Consortium

About this trial

The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate or darolutamide

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants ≥ 18 years of age.

Are willing to be randomized into either study arm and adhere to the study protocol.

Ability to swallow study capsules and/or tablets whole.

Are willing to remain on study treatment and to continue undergoing study imaging despite PSA progression unless clinically deteriorating.

Disqualifiers

Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 2 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer or superficial bladder cancer.

Prior treatment for metastatic CRPC with an ARPI for ≥ 12 weeks.

Prior treatment for non-metastatic CRPC with abiraterone acetate with prednisone, enzalutamide, or apalutamide for ≥ 12 weeks.

Participants who received chemotherapy for castration-sensitive prostate cancer are still eligible provided chemotherapy was completed ≥ 28 days prior to start of study treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Talazoparib with enzalutamide

    Drug

    Talazoparib (0.5 mg PO QD) and enzalutamide (160 mg PO QD) will be administered in continuous 28-day cycles.

  • Talazoparib

    Drug

    Talazoparib (1 mg PO QD) will be administered in continuous 28-day cycles.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Arm AActive comparator 1 intervention
Group B: Arm BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

radiographic progression free survival (rPFS)

To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by rPFS as assessed by the Investigator.

Time frame
From treatment initiation until documented disease progression, death, lost to follow-up, withdrawal, administrative censoring at the time of final analysis, assessed at approximately 42 months from the start of enrollment.

Secondary outcomes

1

Time to PSA50

To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by time to prostate specific antigen (PSA) ≥ 50% decline, summarized using median time-to-event and landmark response rates at 9 and 12 months.

Time frame
Time from treatment initiation until observed PSA50, assessed at approximately 42 months from the start of enrollment.
2

Time to PSA Progression

To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by time to PSA progression.

Time frame
From treatment initiation until documented PSA progression, assessed at approximately 42 months from the start of enrollment.
3

Quality of Life (QoL) by Functional Assessment of Cancer Therapy-Prostate (FACT-P)

Overall QoL measured by FACT-P. Scales: FACT-P Total score (range 0-156), FACT-General (G) Total score (range 0-108), FACT-P Trial Outcome Index (TOI) score (range 0-104). The higher the score, the better the QOL.

Time frame
From prior to treatment initiation (screening) until treatment discontinuation, assessed at approximately 42 months from the start of enrollment.
4

Quality of Life (QoL) by Functional Assessment of Cancer Intervention Therapy-Fatigue Scale (FACIT-Fatigue)

Fatigue measured by FACIT-Fatigue. Scales: FACIT-F Total score (range 0-160), FACT-General (G) Total score (range 0-108), FACIT-F Trial Outcome Index (TOI) score (range 0-108). The higher the score, the better the QOL.

Time frame
From prior to treatment initiation (screening) until treatment discontinuation, assessed at approximately 42 months from the start of enrollment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prostate Cancer Clinical Trials Consortium

Lead sponsor

Pfizer

Collaborator

Dana-Farber Cancer Institute

Collaborator

Memorial Sloan Kettering Cancer Center

Collaborator

Source ClinicalTrials.gov
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