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Anti-tumor antibiotic

Androgen Ablation + Niraparib for Prostate Cancer

Phase 2

Recruiting

Led By Patrick G Pilie

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed prostate carcinoma

Able to swallow study drugs whole as a tablet/capsule

Must not have

Unresolved toxicity from previous anti-cancer therapies

Seizure disorders or conditions predisposing to seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Approved for 50 Other Conditions

Summary

This trial is studying androgen ablation therapy with or without niraparib after radiation therapy in treating patients with prostate cancer.

Who is the study for?

Men over 18 with high-risk localized or locally advanced prostate cancer, who haven't had systemic treatment for it (except ADT within 3 months), can join. They need normal blood counts and organ function, agree to use birth control, and be able to take oral meds. Those with prior major surgery for prostate cancer or certain medical conditions are excluded.

What is being tested?

The trial is testing if adding the drug Niraparib to standard hormone therapy after radiation helps control prostate cancer better than hormone therapy alone. Participants will receive either AAP + ADT or Apa + ADT hormone therapies along with radiation, then possibly Niraparib.

What are the potential side effects?

Possible side effects include fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems, heart issues like hypertension or arrhythmias, liver dysfunction indicated by abnormal tests results, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has been confirmed by lab tests.

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I can swallow pills without any difficulty.

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I am a man aged 18 or older.

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I am willing to continue treatments that lower my testosterone levels.

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I can take care of myself and perform daily activities.

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I am scheduled for prostate cancer treatment with radiation and hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no lasting side effects from past cancer treatments.

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I have a condition that can cause seizures.

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I have had major surgery or radiotherapy for prostate cancer.

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I cannot swallow pills or have a digestive condition affecting drug absorption.

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My prostate cancer has spread to distant parts of my body.

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I do not have active lung inflammation or widespread lung disease.

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I do not have an active, uncontrolled infection or viral hepatitis.

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I have a history or current diagnosis of specific health conditions or cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Eugonadal progression-free survival

Incidence and severity of adverse events (AEs)

Incidence and severity of serious adverse events (SAEs)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 50 Other Conditions

This treatment demonstrated efficacy for 50 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group B (Apa, ADT, XRT, AAP, niraparib)Experimental Treatment7 Interventions

PART 1 NEOADJUVANT PHASE (CYCLES 1-3): Patients receive PO QD on days 1-28, and physician's choice ADT. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. PART 2 RADIATION PHASE (CYCLES 4-6): Within 30 days of completing Part 1, patients undergo radiation therapy. Patients also receive apalutamide PO QD on days 1-28 and physician's choice ADT. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. PART 3 ADJUVANT PHASE (CYCLES 7 AND BEYOND): Patients receive abiraterone acetate PO QD, prednisone PO BID, physician's choice ADT, and niraparib PO QD. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Group A (Apa, ADT, XRT)Active Control4 Interventions

PART 1 NEOADJUVANT PHASE (CYCLES 1-3): Patients receive PO QD on days 1-28, and physician's choice ADT. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. PART 2 RADIATION PHASE (CYCLES 4-6): Within 30 days of completing Part 1, patients undergo radiation therapy. Patients also receive apalutamide PO QD on days 1-28 and physician's choice ADT. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. PART 3 ADJUVANT PHASE (CYCLES 7 AND BEYOND): Patients receive apalutamide PO QD on days 1-28 and physician's choice ADT. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cortisone

Not yet FDA approved

Abiraterone

FDA approved

Antiandrogen Therapy

2015

Completed Phase 1

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