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Antiandrogen
Talazoparib + Enzalutamide for Prostate Cancer
Phase 2
Waitlist Available
Led By Amado Zurita-Saavedra, MD
Research Sponsored by M.D. Anderson Cancer Center
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 through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial will study if adding talazoparib to standard prostate cancer treatment can improve outcomes.
Who is the study for?
Men with prostate cancer that has spread to lymph nodes can join this trial if they're in good enough health for surgery, have not had certain other treatments or conditions, and agree to use contraception. They must also be willing to provide tissue samples and follow the study's procedures.Check my eligibility
What is being tested?
The trial is testing how well talazoparib works when added to standard hormone therapy (ADT) and enzalutamide before surgery in men with prostate cancer. It aims to see if this combination helps reduce the cancer more effectively.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, potential liver issues indicated by abnormal tests, and possibly others depending on individual health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: ADT plus Enzalutamide plus TalazoparibExperimental Treatment5 Interventions
Participant will recive ADT plus Enzalutamide for a total of 8 weeks. After about 8 weeks of ADT and Enzalutamide treatment, participant will begin taking Talazoparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Degarelix
2002
Completed Phase 3
~3600
ADT
2009
Completed Phase 3
~5120
Enzalutamide
2014
Completed Phase 4
~2760
Talazoparib
2021
Completed Phase 2
~2770
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,772 Total Patients Enrolled
95 Trials studying Prostate Cancer
29,710 Patients Enrolled for Prostate Cancer
Amado Zurita-Saavedra, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confirmed to be small cell or sarcomatoid through a biopsy.My cancer has spread to my bones or other areas beyond the original site.I am considered fit for surgery and plan to have a radical prostatectomy after pre-surgery treatment.I have active or symptomatic viral hepatitis or chronic liver disease.I've had hormone therapy for up to 6 weeks and can provide a tumor sample from before starting it.I haven't taken estrogens, cyproterone, or high-dose steroids in the last 4 weeks.I am allergic to certain drug ingredients, including those in talazoparib and enzalutamide.My prostate cancer is considered removable after treatment, including ductal adenocarcinoma.I can walk and take care of myself without help.I stopped taking any medication that could increase my risk of seizures 4 weeks ago.I have not had a gut perforation or abnormal connection in my belly in the last 6 months.I have or had MDS/AML or another cancer with a high chance of returning, except for certain skin, cervical, or bladder cancers.I do not have an infection that could worsen with the trial treatment.I have a condition or history that might increase my risk of seizures.I haven't had serious heart issues or blood clots in the last 6 months.I have not had chemotherapy, experimental treatments, or more than 4 weeks of hormone therapy for prostate cancer.My cancer has been staged.My cancer stage follows the 2018 AJCC guidelines.I do not have a bleeding disorder or significant blood clotting issues.I am mentally capable and compliant with medical advice.I have consulted with both a surgeon and a medical oncologist before agreeing to participate.My high blood pressure is not controlled by medication, or I've had brain issues due to high blood pressure before.My prostate cancer has spread to my lymph nodes.I do not have active lung inflammation or widespread lung disease not caused by cancer.I have a long QT syndrome or my heart's electrical activity takes longer than normal.My scans show small lymph nodes less than 5 cm, and I may need a biopsy.I can take pills and don't have major stomach or intestine issues.I have diabetes or HIV that is not well-controlled.I do not expect to need major surgery during the study, except what's planned in the protocol.
Research Study Groups:
This trial has the following groups:- Group 1: ADT plus Enzalutamide plus Talazoparib
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity to enroll in this investigation?
"The research study detailed on clinicaltrials.gov is currently not recruiting volunteers, as the latest update was made July 26th 2023. Despite this fact, there are presently 1333 other medical studies actively seeking enrolment."
Answered by AI
What potential risks are associated with ADT in combination with Enzalutamide and Talazoparib?
"Although data is still being collected on the efficacy of ADT plus Enzalutamide plus Talazoparib, there is already some evidence to support its safety; thus it was given a rating of 2."
Answered by AI
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