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New treatment option for Metastatic Castrate Resistant Prostate Cancer
Official title Carboplatin or Olaparib for BRcA Deficient Prostate Cancer
ClinicalTrials.gov ID: NCT04038502
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic castrate resistant prostate cancer.
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
- This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L inactivating mutations.
- 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
- Male age \> 18 years
- Diagnosis of prostate cancer (pure small-cell histology or pure high-grade neuroendocrine histology are excluded; neuroendocrine differentiation is...
- Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have not...
- mCRPC as defined by serum testosterone \< 50 ng/ml (for patients on GnRH analogues or antagonists) and at least one of the following:
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
- Male age \> 18 years
- 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. Patients who have not had an orchiectomy must be maintained on effective GnRH...
- mCRPC as defined by serum testosterone \< 50 ng/ml (for patients on GnRH analogues or antagonists) and at least one of the following:
- PSA level of at least 2 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)...
- 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 g/dL
- Absolute neutrophil count (ANC) \> 1.5 x 109/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. bosentan, efavirenz...
- 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's taking place
- West Los Angeles, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Bay Pines, Florida, United States
- Orlando, Florida, United States
- Decatur, Georgia, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- The Bronx, 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 - 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?
Study sites include West Los Angeles, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Bay Pines, Florida, United States; Orlando, Florida, United States; Decatur, Georgia, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.