Actively Recruiting
Talazoparib Plus Enzalutamide After Progression to Abiraterone in Metastatic Prostate Cancer: (TEAM PC)
Led by Fundacion Oncosur · Updated on 2024-12-02
78
Participants Needed
12
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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? * What is the time to disease progression \[radiographic, Prostate Specific Antigen (PSA), clinical\] in participants treated with talazoparib plus enzalutamide after progression on abiraterone? * What medical problems do participants have when receiving talazoparib plus enzalutamide? Researchers will compare the combination of talazoparib and enzalutamide as a first-line treatment for mCRPC to see if the combination improves the PSA response rate and delays progression compared to enzalutamide alone. The safety and tolerability of the combination (talazoparib and enzalutamide) will also be studied
CONDITIONS
Official Title
Talazoparib Plus Enzalutamide After Progression to Abiraterone in Metastatic Prostate Cancer: (TEAM PC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 before registration
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Willing to provide tumor biopsies during the study, including post-treatment biopsy
- Willing to provide blood samples for biomarker analysis
- Consent to DNA damage repair gene sequencing
- Metastatic (M1) prostate cancer documented by bone scan, CT, or MRI
- Asymptomatic or minimally symptomatic prostate cancer at screening
- Estimated life expectancy of at least 6 months from screening
- Ongoing androgen deprivation therapy with GnRH agonist or antagonist if no bilateral orchiectomy
- Disease progression after at least 12 weeks of abiraterone treatment for metastatic hormone-sensitive prostate cancer
- Prior docetaxel allowed if no more than 6 cycles for mHSPC and last dose >6 months before randomization
- Adequate organ function within 28 days before first treatment (specified blood counts, kidney, liver parameters)
- Ability to swallow study medication and comply with study requirements
- Agrees to use effective contraception during study and for 3 months after treatment if sexually active with women of childbearing potential
- Agrees not to donate sperm during study and for 3 months after final abiraterone administration
- Not participating in another interventional study during treatment
- Willing and able to comply with all scheduled visits and procedures
You will not qualify if you...
- Prior abiraterone treatment less than 12 weeks or disease progression within 6 months of starting abiraterone
- Disease progression less than 6 months after last docetaxel dose for mHSPC
- Known or suspected brain metastasis or active leptomeningeal disease
- Superscan on bone scan at screening
- Symptomatic or impending spinal cord compression or cauda equina syndrome
- Use of opiate analgesia for prostate cancer pain with high pain score or uncontrolled pain requiring increasing doses within 4 weeks prior to randomization
- Prior treatment with AR-targeted therapies other than abiraterone, chemotherapy besides docetaxel, immunotherapy, or radiopharmaceuticals
- Recent therapeutic radiation therapy or unresolved radiotherapy toxicities
- Major surgery within 4 weeks prior to randomization or unresolved side effects
- Recent investigational therapeutic or invasive surgical procedures within 30 days
- History of seizures or conditions predisposing to seizures or unexplained loss of consciousness within 1 year
- Congenital long QT syndrome or QTcF greater than 500 milliseconds at screening
- Significant cardiovascular disease including stroke, unstable angina, heart failure NYHA III-IV, uncontrolled hypertension
- Cardiac conduction abnormalities requiring pacemaker or not controlled with medication
- Clinically significant gastrointestinal disorders affecting absorption
- Active or symptomatic viral hepatitis or chronic liver disease
- Known allergies to enzalutamide, talazoparib, or capsule excipients
- Other malignancies except certain in situ or treated cancers with no recurrence
- Any condition that may risk participant safety, confound results, or interfere with study participation
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Institut Català d'Oncologia (ICO)
Badalona, Barcelona, Spain, 08916
Actively Recruiting
2
Consorcio Corporación Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
3
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
4
Hospital Universitario de Jerez de la Frontera
Cadiz, Cádiz, Spain, 11407
Actively Recruiting
5
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain, 48903
Actively Recruiting
6
Hospital Universitario Del Mar.
Barcelona, Spain, 08003
Actively Recruiting
7
Hospital Clínico y Provincial de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
8
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
9
Hospital 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
10
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
11
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
12
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009,
Actively Recruiting
Research Team
L
Luis Gonzaga Paz-Ares Rodríguez
CONTACT
E
Elena Castro, Dra.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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