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Anti-androgens
Antibody-Chemotherapy Combo for Prostate Cancer
Phase 2
Recruiting
Led By Jacob Orme
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if using antibodies, hyaluronidase and chemotherapy drugs can treat prostate cancer that has spread. These drugs work to block signals that tell cells to grow and mark cancer cells for destruction.
Who is the study for?
This trial is for adults with metastatic castration-resistant prostate cancer that has spread and are resistant to second-generation antiandrogens. Participants must be able to complete questionnaires, provide consent, have certain blood levels within normal ranges, and a good performance status. Pregnant or nursing individuals, those with severe diseases or infections, recent thromboembolic events, other active cancers (with exceptions), known drug sensitivities related to the study drugs, uncontrolled illnesses like heart failure or arrhythmias can't join.
What is being tested?
The TraPPer Study is testing the combination of pertuzumab, trastuzumab (both monoclonal antibodies targeting HER2 on cancer cells), hyaluronidase-zzxf (to enhance the effect and administration of these antibodies), and enzalutamide (a chemotherapy drug). The goal is to see if this combo works better at killing prostate cancer cells that no longer respond to typical hormone treatments.
What are the potential side effects?
Potential side effects include allergic reactions due to antibody therapy which may cause organ inflammation; issues from injections under the skin; fatigue; digestive problems; blood disorders from chemotherapy agents like enzalutamide; increased risk of infection due to immune system effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate (ORR)
Secondary study objectives
Incidence of adverse events
Overall survival (OS)
Progression-free survival (PFS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (HP, enzalutamide)Experimental Treatment8 Interventions
Patients receive pertuzumab, trastuzumab, and hyaluronidase-zzxf SC and enzalutamide PO on study. Patients undergo ECHO, biopsy, CT, and MRI scans. Patients also undergo collection of blood and tissue samples.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2740
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Echocardiography
2013
Completed Phase 4
~11580
Enzalutamide
2014
Completed Phase 4
~3820
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,150 Total Patients Enrolled
27 Trials studying Prostate Cancer
6,973 Patients Enrolled for Prostate Cancer
Jacob OrmePrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
20 Total Patients Enrolled
Jacob Orme, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.I can take care of myself and am up and about more than half of my waking hours.I have not had a blood clot in the last 60 days.My mild nerve damage has been stable for 3 months after my last treatment.My blood clotting tests are within normal limits, or controlled if I'm on blood thinners.I still have side effects from my last cancer treatment.I do not have any severe illnesses or conditions that would stop me from following the study's requirements.My prostate cancer is resistant to certain hormone therapies and has spread.My kidneys are functioning well enough, with a creatinine clearance of at least 45 ml/min.I have been treated with medications like enzalutamide or abiraterone before.I am immunocompromised or HIV positive and on antiretroviral therapy.I am not on any experimental drugs for my prostate cancer.I am 18 years old or older.I do not have serious heart conditions or uncontrolled high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (HP, enzalutamide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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