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New treatment option for Prostate Carcinoma
Official title Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT04947254
What this study is testing
What is Abiraterone Acetate?
Abiraterone Acetate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for prostate carcinoma.
Also referred to as CB7630, Zytiga.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Androgen ablation therapy (also known as hormone therapy) lowers the levels of male hormones called androgens in the body.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Completion of informed consent prior to any study specific procedures. Consent may be done remotely.
- Patients must agree to tissue collection for correlative studies at the specified timepoints
- Male aged 18 years and above
- Histologically or cytologically confirmed prostate carcinoma
- Localized or regional high-risk disease as defined by at least one of the following features: Prostate specific antigen (PSA) \> 20 ng/mL, T3a or...
You likely can't join if
- Any prior systemic treatment for prostate cancer with the exception of ADT started within 6 months of trial enrollment. Any prior PARP inhibitor...
- Patients who have prostate cancer with distant metastatic disease
- Patients who have had prior major surgery (prostatectomy) or radiotherapy for the treatment of prostate cancer
- Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade ≥ 2) from previous anti-cancer therapies
- History or current diagnosis of MDS/AML, and/or history of any malignancy [other than the one treated in this study] which has a ≥ 30% probability of...
- Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be...
See the full eligibility criteria
Who can join
- Completion of informed consent prior to any study specific procedures. Consent may be done remotely.
- Patients must agree to tissue collection for correlative studies at the specified timepoints
- Male aged 18 years and above
- Histologically or cytologically confirmed prostate carcinoma
- Localized or regional high-risk disease as defined by at least one of the following features: Prostate specific antigen (PSA) \> 20 ng/mL, T3a or higher, grade group 4-5 (i.e. Gleason score ≥ 8) as per National...
- Planned for definitive treatment of local regional prostate cancer using XRT and androgen ablation
- Willing to undergo ongoing medical castration to maintain testosterone levels of ≤ 50 ng/dL (≤ 2.0 nM) throughout systemic treatment or have undergone bilateral orchiectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. Patients must have adequate organ and bone marrow function measured within 7 days prior to treatment registration as defined below:
- Hemoglobin ≥ 10.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
- White blood cells (WBC) \> 3 x 10\^9/L
- No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear
- Platelet count ≥ 100 x 10\^9/L
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert's disease). (Note: In people with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and...
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal
- Calculated creatinine clearance (Cockcroft-Gault Equation) ≥ 30 mL/min
- Serum Albumin ≥ 3.0
- Serum potassium ≥ 3.5 mmol/L
- Able to swallow study drugs whole as a tablet/capsule
- Patients who have partners of childbearing potential (e.g. female that has not been surgically sterilized or who are not amenorrheic for ≥ 12 months) must be willing to use two methods of birth control including...
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
What rules you out
- Any prior systemic treatment for prostate cancer with the exception of ADT started within 6 months of trial enrollment. Any prior PARP inhibitor therapy
- Patients who have prostate cancer with distant metastatic disease
- Patients who have had prior major surgery (prostatectomy) or radiotherapy for the treatment of prostate cancer
- Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade ≥ 2) from previous anti-cancer therapies
- History or current diagnosis of MDS/AML, and/or history of any malignancy [other than the one treated in this study] which has a ≥ 30% probability of recurrence within 24 months (except for adequately treated...
- Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be allowed on study after discussion with the principal investigator [PI]...
- Active or symptomatic viral hepatitis or chronic liver disease
- Active pneumonitis or extensive bilateral lung disease of non-malignant etiology
- Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples include, but are...
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of study medication
- Patients with a known hypersensitivity to niraparib, apalutamide, and/or abiraterone acetate
- Prisoners or people who are involuntarily incarcerated
- people who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
- Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or...
- Severe or unstable angina, myocardial infarction (within 6 months prior to enrollment), symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident...
- Current evidence of any of the following:
- Gastrointestinal disorder affecting absorption
- Active uncontrolled infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)
- Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
- Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency
- Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant...
- Baseline moderate and severe hepatic impairment (Child-Pugh class B \& C)
- Any condition that in the opinion of the investigator, would preclude participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.