Metastatic Castrate Resistant Prostate Cancer study: Carboplatin vs Olaparib
Official title Carboplatin or Olaparib for BRcA Deficient Prostate Cancer
ClinicalTrials.gov ID: NCT04038502
What this study is testing
What is Carboplatin?
An investigational chemotherapy being studied as a potential treatment for metastatic castrate resistant prostate cancer. It is designed to damage DNA by forming cross‑links that prevent cancer cells from dividing.
Also referred to as Paraplatin.
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
- The study wants to see which drug controls the cancer better and how safe each one is.
- Who it's for
- Men with metastatic castration‑resistant prostate cancer that carries specific DNA‑repair gene mutations.
- What's involved
- Participants are randomly given either carboplatin by IV every 3 weeks or oral olaparib twice a day. They stay on the first drug until side effects or cancer growth, then may switch to the other drug. Regular scans and blood tests are done to check the cancer.
- Time commitment
- Treatment continues until the cancer progresses or side effects force stopping, with clinic visits every 3 weeks for carboplatin or monthly for olaparib, plus periodic imaging appointments.
- 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
- Signed study informed consent form (ICF) and HIPAA authorization form
- Diagnosis of prostate cancer (pure small-cell histology or pure high-grade neuroendocrine histology are excluded
- Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy.
- 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...
- Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
You likely can't join if
- Currently receiving active therapy for other neoplastic disorder(s)
- Concurrent enrollment in another clinical investigational drug or device study
- Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendocrine differentiation without morphologic...
- Prior treatment with platinum, mitoxantrone or PARP inhibitor for castration resistant prostate cancer
- Known parenchymal brain metastasis
- 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...
See the full eligibility criteria
- Signed study informed consent form (ICF) and HIPAA authorization form
- Diagnosis of prostate cancer (pure small-cell histology or pure high-grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed)
- Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy.
- 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
- Prior therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide
- Eastern Cooperative Oncology Group (ECOG) Performance Status of \< 2 (see Appendix 3, ECOG Grading Scale)
- 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)...
- 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...
- 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)
- Currently receiving active therapy for other neoplastic disorder(s)
- Concurrent enrollment in another clinical investigational drug or device study
- Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendocrine differentiation without morphologic evidence is not exclusionary)
- Prior treatment with platinum, mitoxantrone or PARP inhibitor for castration resistant prostate cancer
- Known parenchymal brain metastasis
- 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)
- people with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML
- 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...
- 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.
- people unable to swallow orally administered medication and people with gastrointestinal disorders likely to interfere with absorption of the study medication
- 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...
- Treatment with an investigational therapeutic within 30 days of Cycle-1
- Presence of dementia, psychiatric illness, and/or social situations limiting compliance with study requirements or understanding HIPAA authorization and/or giving of informed consent
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- West Los Angeles, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Orlando, Florida, United States
- Decatur, Georgia, United States
- Boise, Idaho, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Madison, Wisconsin, 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, but 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?
This study is enrolling now at West Los Angeles, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Orlando, Florida, United States; Decatur, Georgia, United States; Boise, Idaho, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.