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Hormone Therapy

Combination Therapies for Metastatic Prostate Cancer (KNIGHTS Trial)

Phase 2

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone, soft tissue, or extra-pelvic nodal region each < 5 cm or < 250 cm3 that develop within the past 6-months that are seen on imaging

Histologic confirmation of prostate adenocarcinoma (primary or metastatic tumor)

Must not have

Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy

Suspected intracranial and/or liver metastases (>10 mm in largest axis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two treatments for recurrent metastatic prostate cancer. One treatment is the standard of care, which includes hormonal therapy and radiation to the metastatic lesions. The other treatment adds a combination of

Who is the study for?

This trial is for individuals with recurrent metastatic prostate cancer, specifically those who have a small number of secondary tumors (oligometastatic). Participants should be suitable for hormonal therapy and targeted radiation (SABR), but details on specific inclusion and exclusion criteria are not provided.

What is being tested?

The study compares standard treatment (hormonal therapy + SABR) to the same standard care plus a 6-month course of niraparib/abiraterone acetate pills and prednisone. The goal is to see if adding these medications improves outcomes.

What are the potential side effects?

Potential side effects may include issues related to hormonal changes from ADT, such as fatigue or sexual dysfunction; radiation side effects like skin irritation; and drug-related effects from niraparib/abiraterone like nausea, heart problems, or blood pressure changes.

Eligibility Criteria

Inclusion Criteria

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

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I have 1-3 small, symptom-free tumors outside the pelvis seen on scans in the last 6 months.

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My prostate cancer diagnosis was confirmed through a tissue sample.

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My prostate cancer is not responding to hormone therapy.

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I have a high-risk genetic mutation linked to cancer.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

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

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I've had radiation on the same spot where my cancer is now, preventing more radiation.

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I might have cancer spread to my brain or liver, larger than 10 mm.

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I cannot lie flat for scans or certain cancer treatments.

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I haven't had a heart attack, uncontrolled high blood pressure, or heart failure in the last 6 months.

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My prostate cancer is of the small cell or neuroendocrine type.

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I have had issues with my adrenal glands.

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I am not on long-term steroids higher than 5mg of prednisone.

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I have no other cancers needing treatment changes in the last 2 years.

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I am allergic to ingredients in niraparib/abiraterone tablets.

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I have another active cancer or a history of AML/MDS.

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I have or had myelodysplastic syndrome or acute myeloid leukemia.

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My high blood pressure is not controlled.

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I have a condition that makes it unsafe for me to take prednisone.

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I am on HIV medication that might affect the study drug.

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My liver is not working well (moderate to severe issues).

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I have been treated with a PARP inhibitor before.

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I have or am at risk of having spinal cord compression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

PSA (Prostate Specific Antigen) evaluation at the 18-month progression of both treatment arms

Secondary study objectives

Local control at 18 months after ADT+ SABR MDT (6-mos) vs ADT + SABR MDT + niraparib/abiraterone acetate and prednisone (6-mos) in patients with metachronous oligometastatic Castrate Specific Prostate Cancer (CSPC) disease.

Quality-of-life measured through EPIC tool following completion of ADT+ SABR MDT (6-mos) vs ADT + SABR MDT + niraparib/abiraterone acetate and prednisone (6-mos).

Time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival and duration of response after randomization

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