Study on High-Risk Metachronous Oligometastatic Prostate Cancer
Sponsor: University of Maryland, Baltimore
ClinicalTrials ID:NCT06212583
This clinical trial is comparing the effects of standard treatment with hormonal therapy and targeted radiation to metastatic lesions, against the same treatment plus a 6-month course of additional medications (niraparib and abiraterone acetate) and prednisone, for patients with recurrent metastatic prostate cancer.
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Program Overview
The aim of this study is to see if adding a combination of medications (niraparib and abiraterone acetate) and prednisone to the standard treatment of hormonal therapy and targeted radiation can improve outcomes for patients with recurrent metastatic prostate cancer. Participants will be randomly assigned to receive either the standard treatment alone or the standard treatment plus the additional medications. Both groups will undergo various tests, including blood tests and quality-of-life surveys, to monitor their health and the effects of the treatment.
Description
In this study, participants will be divided into two groups by random selection, similar to flipping a coin. One group will receive the standard treatment, which includes hormonal therapy and targeted radiation (SABR) to the cancer that has spread. The other group will receive the same standard treatment plus a 6-month course of additional medications (niraparib and abiraterone acetate) and prednisone.
Both groups will have regular check-ups, including rectal swabs and blood tests, to monitor circulating tumor cells, genetic information, and tumor markers. Participants will also complete surveys about their quality of life during the study.
The study aims to determine if the additional medications can provide better control of the cancer compared to the standard treatment alone.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have 1 to 3 small, painless metastatic tumors in the bone, soft tissue, or outside the pelvic area, each less than 5 cm, that appeared in the last 6 months.
- Have a high-risk genetic mutation (e.g., TP53, BRCA1/2).
- Confirmed diagnosis of prostate adenocarcinoma.
- May have had previous systemic therapy if testosterone levels are above 100 ng/dl.
- PSA levels between 0.5 and 50 at enrollment.
- PSA doubling time less than 15 months.
- Baseline testosterone above 100 ng/dl.
- Life expectancy of at least 12 months.
- ECOG performance status of 0 to 2.
- Adequate blood, kidney, and liver function.
- Able to understand and sign informed consent.
- Able to swallow study medication tablets.
- Agree to use contraception and not donate sperm during and for 4 months after treatment.
Exclusion Criteria
- Have castration-resistant prostate cancer.
- Previous radiation to a target lesion that prevents further radiation.
- Spinal cord compression or risk of it.
- Suspected brain or liver metastases larger than 10 mm.
- Receiving other investigational treatments.
- Unable to receive systemic therapy.
- Cannot lie flat for imaging or radiation.
- Evidence of brain metastasis.
- Active second primary cancer.
- Uncontrolled high blood pressure or recent heart issues.
- Prior treatment with PARP inhibitors.
- Refusal to sign consent.
- Small cell or neuroendocrine prostate cancer.
- History of adrenal issues.
- Long-term use of systemic corticosteroids.
- Active malignancies needing treatment change in the last 24 months.
- Recent severe heart or blood vessel issues.
- Uncontrolled high blood pressure.
- Allergies to study medications.
- Medical conditions contraindicating prednisone.
- Recent investigational treatments or devices.
- HIV positive with certain conditions.
- Active or symptomatic liver disease.
- Moderate or severe liver impairment.
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