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Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of British Columbia

About this trial

The objective of this study is to see if providing an appropriate therapy based on the genomic testing of prostate tumour tissue will result in an improved clinical response.

Each participant will be treated with 8 weeks of a luteinizing hormone-releasing hormone agonist (LHRHa) plus apalutamide (APA) while genome sequence characterization is being done. Participants with biopsy specimens deemed unevaluable for genomic testing will remain on LHRHa plus APA for an additional 16 weeks.

Participants with evaluable tissue will be assigned to one of the open-label sub-studies on the basis of genomic profiling results. Within each group, they will be randomized to a specific treatment arm either LHRHa plus APA alone or adding abiraterone acetate and prednisone, docetaxel or niraparib.

The study will evaluate the response rate and outcomes after radical prostatectomy in each arm of the trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any combination of Gleason Score 4+3=7 and Gleason Score 8 (4+4 or 5+3) in ≥6 systematic cores (with ≥1 core Gleason Score 8 [4+4 or 5+3] included);

Any combination of Gleason Score 4+3 and Gleason Score 8 (4+4 or 5+3) in ≥3 systematic cores and PSA ≥20 ng/mL (with at least 1 core Gleason Score 8 [4+4 or 5+3] included);

Gleason Score ≥9 in at least 1 systematic or targeted core;

At least 2 systematic or targeted cores with Gleason Score ≥8, each with at least 80% involvement"; or

Disqualifiers

Active infection or chronic liver disease requiring systemic therapy;

Active or known human immunodeficiency virus (HIV) with detectable viral load;

Participants with uncontrolled hypertension or diabetes.

Severe or unstable angina, symptomatic pericarditis, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease, coronary artery bypass grafting, coronary angioplasty, stenting, or myocardial infarction; uncomplicated deep vein thrombosis is not considered exclusionary).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Apalutamide 60mg Tab

    Drug

    4 tablets by mouth once a day for 24 weeks

  • Abiraterone Acetate 250mg

    Drug

    4 tablets by mouth on an empty stomach once a day for 16 weeks

  • Prednisone 5mg Tab

    Drug

    1 tablet by mouth once daily while taking abiraterone acetate

  • Docetaxel

    Drug

    Infusion every 3 weeks for 6 cycles (each cycle has 3 weeks)

  • Niraparib 100mg Oral Capsule

    Drug

    3 capsules by mouth once daily for 16 weeks

  • Atezolizumab

    Drug

    1200mg infusion every 3 weeks for 6 cycles

  • Tazemetostat Pill

    Drug

    200 mg 4 tablets by mouth twice daily with or without food for 16 weeks

  • Capivasertib

    Drug

    200 mg 2 tablets by mouth twice a day with or without food on an intermittent dosing schedule (days 1-4, then 3 days off) each week for 16 weeks

Treatment groups

315 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Group 1aActive comparator 1 intervention
Group B: Group 1bActive comparator 3 interventions
Group C: Group 2aActive comparator 2 interventions
Group D: Group 2bActive comparator 3 interventions
Group E: Group 3Active comparator 3 interventions
Group F: Group 4Active comparator 2 interventions
Group G: Group 5Active comparator 3 interventions
Group H: Group 6Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Complete Pathologic Response (pCR)

Pathological Minimal Residual Disease (pMRD): pathological minimal residual disease (pMRD) is defined as residual tumour 5mm or less.

Time frame
6 years
2

Pathological Minimal Residual Disease (pMRD)

Pathological minimal residual disease is defined as residual tumour 5 mm or less.

Time frame
6 years

Secondary outcomes

1

Pain level assessment

The Brief Pain Inventory-Short Form (BPI-SF) is a 9-item, self administered questionnaire which evaluates the severity of a participant's level of pain and impact on daily functioning. This questionnaire will be administered at screening, prior to receiving master protocol therapy (0 weeks), the end of receiving therapy (8 weeks), as well as the End of Treatment (EoT) visit.

Time frame
6 years
2

Generic Quality of Life (QoL)

The EQ-5D-5L is a widely used instrument developed in Europe to evaluate the generic quality of life. The EQ-5D-5L has two components: the EQ-5D descriptive system and the EQ visual analogue scale. This questionnaire will be administered at screening, prior to receiving master protocol therapy (0 weeks), the end of receiving therapy (8 weeks) as well as at the EoT visit.

Time frame
6 years
3

Quality of Life-Prostate Cancer Patients

This will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with patients who have prostate cancer. This questionnaire will be administered at screening, prior to receiving master protocol therapy (0 weeks), the end of receiving therapy (8 weeks) as well as at the EoT visit.

Time frame
6 years

Other outcomes

Sponsors and contacts

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

University of British Columbia

Lead sponsor

Janssen Inc.

Collaborator

University Health Network, Toronto

Collaborator

Source ClinicalTrials.gov
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