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New treatment option for Metastatic Prostate Cancer
Official title Talazoparib Plus Enzalutamide After Progression to Abiraterone in Metastatic Prostate Cancer: (TEAM PC)
ClinicalTrials.gov ID: NCT06582628
What this study is testing
What is Enzalutamide capsule?
Enzalutamide capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic prostate cancer.
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 purpose of this clinical trial is to determine the anti-tumor activity of talazoparib plus enzalutamide as first line treatment for metastatic castration resistant prostate cancer (mCRPC) in participants whose disease has progressed on abiraterone. The main questions it aims to answer are: Does talazoparib plus enzalutamide improve efficacy in metastatic castration resistant prostate cancer (mCRPC) compared to enzalutamide alone?
- 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
- Male age 18 or older.
- Histological diagnosis of prostate adenocarcinoma without neuroendocrine differentiation or small cell features.
- Willing and able to provide written informed consent to participate in the study. Written consent must be given before registration, according to...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Willing to provide tumor biopsies during the study. Note: At study entry, the pre-treatment fresh tumor biopsy could be replaced by an archived tumor...
You likely can't join if
- Prior abiraterone treatment for less than 12 weeks or disease progression (either PSA or radiographic progression) within 6 months of starting...
- Disease progression less than 6 months after the last administration of docetaxel for mHSPC.
- Known or suspected brain metastasis or active leptomeningeal disease.
- A finding of superscan in a bone scan at screening. Superscan is defined as a bone scan which demonstrates markedly increased skeletal radioisotope...
- Symptomatic or impending spinal cord compression or cauda equina syndrome.
- Use of opiate analgesia for pain from prostate cancer with average Brief pain inventory (BPI) questionnaire score higher than 6 and/or uncontrolled...
See the full eligibility criteria
Who can join
- Male age 18 or older.
- Histological diagnosis of prostate adenocarcinoma without neuroendocrine differentiation or small cell features.
- Willing and able to provide written informed consent to participate in the study. Written consent must be given before registration, according to International Council for Harmonisation of Technical Requirements for...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Willing to provide tumor biopsies during the study. Note: At study entry, the pre-treatment fresh tumor biopsy could be replaced by an archived tumor biopsy upon agreement from the study chief investigator if such...
- Willing to provide blood samples for biomarker analysis.
- Willing to give consent to sequencing of DNA damage repair (DDR) genes for analysis of the prevalence of somatic and germline aberrations in DNA damage repair genes.
- Metastatic (M1) prostate cancer documented by bone scan, or soft tissue disease documented by computed tomography (CT), or magnetic resonance imaging (MRI).
- Asymptomatic or minimally symptomatic prostate cancer at screening.
- Estimated life expectancy of greater than or equal to 6 months from screening.
- Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist or antagonist for participants who have not undergone bilateral orchiectomy must be in place before screening and must...
- Haemoglobin greater than or equal to 10 g/dL, no blood transfusions within 14 days before obtaining the haematology laboratory tests at screening,
- Platelets greater than or equal to 100,000/μL no platelets transfusions within 14 days before obtaining the haematology laboratory tests at screening,
- Neutrophils greater than or equal to 1500/μL, no growth factors given within 14 days before obtaining the haematology laboratory tests at screening,
- Serum creatinine less than1.5X ULN or calculated creatinine clearance greater than or equal to 50 mL/min
- Albumin greater than 3 g/dL,
- AST or ALT less than 2.5 × ULN (less than 5 × ULN if liver function abnormalities are due to hepatic metastasis).
- Total serum bilirubin less than 1.5 × ULN (less than 3 × ULN for participants with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation). 15\. Ability to...
What rules you out
- Prior abiraterone treatment for less than 12 weeks or disease progression (either PSA or radiographic progression) within 6 months of starting abiraterone.
- Disease progression less than 6 months after the last administration of docetaxel for mHSPC.
- Known or suspected brain metastasis or active leptomeningeal disease.
- A finding of superscan in a bone scan at screening. Superscan is defined as a bone scan which demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint...
- Symptomatic or impending spinal cord compression or cauda equina syndrome.
- Use of opiate analgesia for pain from prostate cancer with average Brief pain inventory (BPI) questionnaire score higher than 6 and/or uncontrolled prostate cancer-related pain requiring increasing doses of opiates...
- Prior treatment with an AR-targeted therapy (enzalutamide, apalutamide, darolutamide, ketoconazole) other than abiraterone for mHSPC; chemotherapy other than 6 cycles of docetaxel for mHSPC, immunotherapy or...
- Therapeutic radiation therapy within, 14 days (7 days for limited-field palliative radiotherapy) prior to study enrolment, or participants who have not recovered from radiotherapy-related toxicities to grade less than...
- Major surgery within 4 weeks prior to randomization or participants who have not recovered from the side effects of any major surgery.
- Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 30 days of Cycle 1 Day 1 or currently enrolled in an investigational study.
- History of seizure or any condition that may predispose to seizure (i.e., prior significant brain trauma, brain vascular malformation, etc) or people that have had an unexplained loss of consciousness or transient...
- Congenital long QT syndrome or ECG at screening with QT interval corrected using Fridericia's formula (QTcF) greater than 500 milliseconds.
- articipants with clinically significant cardiovascular disease including but not limited to any of the following:
- Stroke, transient ischemic attack, unstable angina pectoris or documented myocardial infarction within 12 months prior to study entry.
- Symptomatic pericarditis or clinically significant pericardial effusion or myocarditis
- Documented congestive heart failure (New York Heart Association Class, NYHA functional classification III-IV)
- Uncontrolled, persistent hypertension defined as systolic blood pressure less than 170mmHg or diastolic blood pressure less than100mmHg. people with a history of hypertension are allowed provided blood pressure is...
- Participants with any of the following cardiac conduction abnormalities: Ventricular arrhythmias except for benign premature ventricular contractions
- Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication.
- Conduction abnormality requiring a pacemaker.
- Other cardiac arrhythmia not controlled with medication.
- Any clinically significant gastrointestinal disorder affecting absorption (i.e., extensive small bowel resection, active inflammatory bowel disease).
- Active or symptomatic viral hepatitis or chronic liver disease.
- Known/possible hypersensitivity, allergies to enzalutamide, talazoparib or any of capsule excipients.
- Other malignancy except:
- Carcinoma in situ or non-melanoma skin cancer.
- A cancer diagnosed and treated greater than or equal to 5 years before randomization with no subsequent evidence of recurrence.
- Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subject's participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Badalona, Barcelona, Spain
- Sabadell, Barcelona, Spain
- Santander, Cantabria, Spain
- Cadiz, Cádiz, Spain
- Barakaldo, Vizcaya, Spain
- Barcelona, Spain
- Madrid, Spain
- Málaga, Spain
- Zaragoza, Spain
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 Badalona, Barcelona, Spain; Sabadell, Barcelona, Spain; Santander, Cantabria, Spain; Cadiz, Cádiz, Spain; Barakaldo, Vizcaya, Spain; Barcelona, Spain and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.