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Which drug first? trial tests sequence of carboplatin and olaparib in aggressive prostate cancer

NCT ID NCT04038502

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are comparing two sequences of treatment for metastatic castration-resistant prostate cancer that carries certain DNA repair gene mutations. Participants receive either carboplatin first and olaparib second, or olaparib first and carboplatin second, switching after the cancer worsens. The trial measures how long each sequence keeps the cancer from progressing. About 100 people will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
carboplatin and olaparib, two cancer drugs given in a different order
What this could lead to
If one order works better, doctors could plan which drug to give first for prostate cancers with these DNA repair mutations.
What could go wrong
This is a mid-stage trial with about 100 people, so results may not hold in larger groups. Both drugs can cause side effects, and cancers often stop responding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed study informed consent form (ICF) and HIPAA authorization form 2. Diagnosis of prostate cancer (pure small-cell histology or pure high-grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed) 3. Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapy 4. mCRPC as defined by serum testosterone \< 50 nanograms per milliliter (ng/ml) for patients on GnRH analogues or antagonists) and at least one of the following: * Prostate-specific antigen (PSA) level of at least 2 nanograms per milliliter (ng/ml) that has risen on at least 2 successive occasions at least 1 week apart * Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) * Progression of metastatic bone disease on bone scan, CT or MRI with \> 2 new lesions 5. Prior therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of \< 2 (see Appendix 3, ECOG Grading Scale) 7. Results of previous standard DNA testing, or previous research testing, which confirms RAD51B, RAD51C, RAD51D, or RAD54L mutations (see Introduction, Section 2 for study design and previous research on targeted therapy) from primary, metastatic tumor or circulating tumor DNA, or pathogenic/likely pathogenic germline variant as assessed by a CLIA certified laboratory level assay for DNA sequencing. 8. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: * Hemoglobin \> 10.0 grams per deciliter (g/dL) * Absolute neutrophil count (ANC) \> 1.5 x 109/liter (L) * Platelet count \> 100 x 109/L * Total bilirubin \< 1.5 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT) \< 2.5 x institutional upper limit of normal unless liver metastases are present in which case, they must be \< 5x ULN * Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of \>51 mL/min: Estimated creatinine clearance =(140-age \[years\]) x weight (kg)/(serum creatinine (mg/dL) x 72) Exclusion Criteria: 1. Currently receiving active therapy for other neoplastic disorder(s) 2. Concurrent enrollment in another clinical investigational drug or device study 3. Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendocrine differentiation without morphologic evidence is not exclusionary) 4. Prior treatment with platinum, mitoxantrone or PARP inhibitor for castration resistant prostate cancer 5. Known parenchymal brain metastasis 6. Active or symptomatic viral hepatitis or chronic liver disease AST or ALT \> 2.5 x ULN or total bilirubin \> ULN (unless Gilbert's syndrome is the etiology of hyperbilirubinemia) 7. Subjects with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML 8. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks 9. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents 10. Subjects unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with absorption of the study medication 11. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 35 % at baseline 12. Treatment with an investigational therapeutic within 30 days of Cycle-1 13. Presence of dementia, psychiatric illness, and/or social situations limiting compliance with study requirements or understanding HIPAA authorization and/or giving of informed consent 14. Any condition(s), medical or otherwise, which, in the opinion of the Investigators, would jeopardize either the patient or the integrity of the data obtained

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma Fanconi anemia complementation group D1 Fanconi anemia complementation group N hereditary sensory and autonomic neuropathy prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BARD1, BRCA1, BRCA2, BRIP1, CHEK1, fancl, PALB2 Metastatic castrate resistant prostate cancer RAD51B, RAD51C, RAD51D, or RAD54L mutations

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    RECRUITING

    Decatur, Georgia, 30033, United States

  • Bay Pines VA Healthcare System, Pay Pines, FL

    TERMINATED

    Bay Pines, Florida, 33744-0000, United States

  • Boise VA Medical Center, Boise, ID

    RECRUITING

    Boise, Idaho, 83702, United States

  • Durham VA Medical Center, Durham, NC

    RECRUITING

    Durham, North Carolina, 27705-3875, United States

  • James J. Peters VA Medical Center, Bronx, NY

    TERMINATED

    The Bronx, New York, 10468-3904, United States

  • Jesse Brown VA Medical Center, Chicago, IL

    TERMINATED

    Chicago, Illinois, 60612, United States

  • Kansas City VA Medical Center, Kansas City, MO

    RECRUITING

    Kansas City, Missouri, 64128, United States

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

    RECRUITING

    New York, New York, 10010, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    RECRUITING

    Minneapolis, Minnesota, 55417-2309, United States

  • Orlando VA Medical Center, Orlando, FL

    RECRUITING

    Orlando, Florida, 32827, United States

  • Philadelphia MultiService Center, Philadelphia, PA

    RECRUITING

    Philadelphia, Pennsylvania, 19106, United States

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    RECRUITING

    Aurora, Colorado, 80045, United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    RECRUITING

    West Los Angeles, California, 90073, United States

  • VA Portland Health Care System, Portland, OR

    RECRUITING

    Portland, Oregon, 97239, United States

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    RECRUITING

    Seattle, Washington, 98108-1532, United States

  • Washington DC VA Medical Center, Washington, DC

    RECRUITING

    Washington D.C., District of Columbia, 20422-0001, United States

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    RECRUITING

    Madison, Wisconsin, 53705-2254, United States

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