Prostate cancer study pulled before it began
NCT ID NCT06527690
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to see if a person's race or ethnicity changes how well a combination of drugs (niraparib, abiraterone acetate, and prednisone) works for a specific type of advanced prostate cancer. It planned to compare Black or Hispanic participants with White or Native American participants. However, the study was withdrawn before any patients were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
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Apr 2025
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Eligibility criteria - Prescreening Inclusion Age: ≥18 years of age (or the local legal age of consent) Participant Origin: Participants of the following origins: \- COHORT A: Participants self-identified as with black origin as defined as having origins in any of the black racial groups of Africa, as per the FDA Guidance on Collection of Race and Ethnicity Data in Clinical Trials, and irrespective of ethnicity. This includes participants with more than one race, including pardos. \- COHORT B: Participants self-identified from Native Indigenous American origins as per the FDA Guidance on Collection of Race and Ethnicity Data in Clinical Trials, irrespective of ethnicity. This includes participants with more than one race, including mestizos. OR \- Participants self-identified from White origin as per the FDA Guidance on Collection of Race and Ethnicity Data in Clinical Trials, and ethnically self-identified as Latinos. Participant and Disease Characteristics * ECOG Performance Status 0-1 * Histologically or cytologically confirmed metastatic prostate adenocarcinoma * Metastatic disease documented by conventional imaging with CT or MRI (for soft tissue lesions) or 99mTc bone scan (for bone lesions) 1. Participants with a single bone lesion on 99mTc bone scan with no other non-nodal metastatic disease must have confirmation of bone metastasis by CT or MRI. 2. Participants with lymph node-only disease are not eligible. * Willing to provide tumor tissue (archival) for determination of deleterious germline or somatic HRR gene alterations, if no local (testing done at investigator center or commercial testing) or prior sponsor-approved test result is available. 1.Testing must demonstrate pathogenic gene alterations in ≥1 of the following genes to proceed to screening: ATM, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, HDAC2, or PALB2. * Castration-resistant disease, defined by the PCWG3 as any of the following criteria while on castrate levels of testosterone (less than or equal to 50 ng/dL): 1. Visceral Progression OR 2. Bone progression (2 or more new prostate-cancer related new lesions compared to baseline) OR 3. PSA Progression, as defined by an increase in two consecutive measurements that fulfills all the following criteria: 1. The evaluations were performed with a minimum interval of 1 week. 2. Progressive worsening with an increase of at least 50% compared to baseline. 3. The minimum value of PSA is ≥ 1 ng/ml.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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