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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite radiographic progression-free survival(rPFS) and biochemical (PSA) progression-free survival (PFS)

Secondary outcome measures

Eugonadal progression-free survival

Incidence and severity of adverse events (AEs)

Incidence and severity of serious adverse events (SAEs)

+2 more

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

~10

Apalutamide

FDA approved

Biopsy

2014

Completed Phase 4

~1090

Niraparib

FDA approved

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,196 Total Patients Enrolled

95 Trials studying Prostate Cancer

29,540 Patients Enrolled for Prostate Cancer

Patrick G PiliePrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Abiraterone Acetate (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04947254 — Phase 2

Prostate Cancer Research Study Groups: Group A (Apa, ADT, XRT), Group B (Apa, ADT, XRT, AAP, niraparib)

Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT04947254 — Phase 2

Abiraterone Acetate (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04947254 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what illnesses or conditions is Radiation Therapy often prescribed?

"Radiotherapy is frequently used to manage scalp structure, as well as thyroiditis, prostate cancer non-metastatic issues, and ulcerative colitis."

Answered by AI

Is enrollment available for this investigation yet?

"As per information on clinicaltrials.gov, this medical experiment is actively seeking volunteers to participate. It was initially posted in August 2021 and the latest update occurred just over a year later on 8/10/2022."

Answered by AI

What measurable outcomes have researchers observed from previous Radiation Therapy research studies?

"At present, 549 trials related to radiation therapy are underway. Out of those studies, 139 have advanced to the third phase of clinical testing. Most research is conducted at one center in Duarte, California; however a total 21460 other medical centres also host radiation therapy experiments."

Answered by AI

How many participants are being tracked in this research project?

"Affirmative. As per the records on clinicaltrials.gov, this research project is actively recruiting patients at 1 site and has a target enrolment of 200 participants since it was first posted in August 5th 2021 and last updated in August 10th 2022."

Answered by AI

What degree of risk is associated with Radiation Therapy for patients?

"The safety of Radiation Therapy was rated a 2 out of 3 by our staff due to the fact that this Phase 2 trial has only acquired limited evidence on its safeguarding."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer

2021. "Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04947254.

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