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Androgen Deprivation Therapy
Talazoparib + ADT + Abiraterone for Prostate Cancer
Phase 2
Recruiting
Led By Tanya B Dorff
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients must have metastatic disease: either soft tissue and/or bony metastases prior to initiation of androgen. Measurable disease is not required
Calculated creatinine clearance >= 30 mL/min using a serum creatinine obtained within 28 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying the effect of talazoparib with androgen deprivation therapy and abiraterone in treating patients with castration sensitive prostate cancer.
Who is the study for?
This trial is for men with castration sensitive prostate cancer that has spread, and who have not had certain treatments. They must be able to perform daily activities without significant assistance (Karnofsky performance status of 60-100). Participants need normal liver function tests, a creatinine clearance >=30 mL/min, and agree to use contraception or abstain from intercourse during the study.Check my eligibility
What is being tested?
The trial is testing talazoparib combined with androgen deprivation therapy (ADT) and abiraterone. Talazoparib blocks an enzyme called PARP which helps repair DNA in tumor cells; ADT lowers body's production of androgens that can promote tumor growth; abiraterone works alongside ADT to further reduce androgen levels.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, heart issues like high blood pressure or heart failure symptoms worsening if pre-existing conditions are present. Allergic reactions could occur based on individual sensitivities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to other parts of my body, including bones or soft tissues.
Select...
My kidney function, measured by creatinine clearance, is adequate.
Select...
I am willing to stop taking bicalutamide if I join the trial.
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I can care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate specific antigen (PSA) nadir < 0.2
Secondary outcome measures
Androgen receptor (AR) genetic variations
Objective response rate
PSA responses
+2 moreOther outcome measures
Circulating tumor deoxyribonucleic acid (ctDNA)
Side effects data
From 2018 Phase 1 & 2 trial • 40 Patients • NCT0211677789%
Anemia
78%
Alkaline phosphatase increased
78%
Nausea
78%
White blood cell decreased
67%
Fatigue
67%
Lymphocyte count decreased
56%
Aspartate aminotransferase increased
56%
Hypermagnesemia
56%
Headache
56%
Neutrophil count decreased
56%
Platelet count decreased
56%
Pain in extremity
44%
Constipation
44%
Hypoalbuminemia
44%
Non-cardiac chest pain
44%
Hyponatremia
33%
Creatinine increased
33%
Hypocalcemia
33%
Anorexia
33%
Back pain
33%
Diarrhea
33%
Alanine aminotransferase increased
33%
Alopecia
33%
Blood bilirubin increased
33%
Dizziness
33%
Fever
33%
Hyperglycemia
33%
Pain
33%
Proteinuria
33%
Sinus tachycardia
33%
Vomiting
22%
Hypokalemia
22%
Cough
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Weight loss
11%
Periorbital infection
11%
Bone pain
11%
Allergic reaction
11%
Tumor pain
11%
Febrile neutropenia
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Edema limbs
11%
Irregular menstruation
11%
Dysgeusia
11%
Hemoglobin increased
11%
Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT
11%
Skin and subcutaneous tissue disorders - Other, ERYTHEMA
11%
Urinary urgency
11%
Renal and urinary disorders - Other, BLADDER PAIN
11%
Anxiety
11%
Avascular necrosis
11%
Depression
11%
Hypomagnesemia
11%
Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA
11%
Edema face
11%
Hematuria
11%
Lymphocyte count increased
11%
Activated partial thromboplastin time prolonged
11%
Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY
11%
Cystitis noninfective
11%
Epistaxis
11%
Gait disturbance
11%
Gastroesophageal reflux disease
11%
Hypertension
11%
Infections and infestations - Other, SHINGLES ZOSTER
11%
Insomnia
11%
Investigations - Other, BICARBONATE DECREASED
11%
Investigations - Other, BICARBONATE INCREASED
11%
Investigations - Other, BICARBONATE LOW
11%
Metabolism and nutrition disorders - Other, CHLORIDE LEVEL
11%
Mucosal infection
11%
Muscle weakness right-sided
11%
Pericardial effusion
11%
Pleural effusion
11%
Rash acneiform
11%
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA
11%
Skin hyperpigmentation
11%
Skin ulceration
11%
Stomach pain
11%
Thromboembolic event
11%
Tinnitus
11%
Urinary retention
11%
Obesity
100%
80%
60%
40%
20%
0%
Study treatment Arm
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (talazoparib, androgen deprivation therapy)Experimental Treatment8 Interventions
Patients receive talazoparib PO QD, abiraterone acetate PO QD, and prednisone PO QD on days 1-28. Patients also receive androgen deprivation therapy consisting of degarelix SC on day 1; leuprolide acetate IM on day 1 and bicalutamide PO QD on days 1-28 of cycle 1 and then leuprolide acetate IM on day 1 of subsequent cycles; leuprolide acetate IM on day 1 and bicalutamide PO QD on days 1-28 of cycle 1 and then leuprolide acetate IM on day 1 of cycles 2, 5, 8, and 11; or goserelin acetate SC monthly or every 3 months. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
FDA approved
Abiraterone
FDA approved
Bicalutamide
FDA approved
Degarelix
FDA approved
Goserelin
FDA approved
Lidocaine
FDA approved
Talazoparib
FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,390 Total Patients Enrolled
14 Trials studying Prostate Cancer
5,613 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,835 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
Tanya B DorffPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a history of adrenal insufficiency.My cancer has spread to other parts of my body, including bones or soft tissues.I finished chemotherapy aimed at curing my cancer more than 2 years ago.I have not had chemotherapy for metastatic prostate cancer.I am taking or plan to take bone-strengthening drugs that don't affect PSA levels.My cancer was imaged close to when I started hormone therapy.I had surgery over 2 weeks ago and have recovered from major side effects.I agree to use contraception or abstain from sex during and for 4 months after treatment.I've had hormone therapy for prostate cancer, but not longer than 36 months and it's been over 6 months since my last treatment.I do not have brain metastases.It's been over a year since my last LHRH injection and my testosterone is above 150 ng/dL.I do not have any stomach or intestine problems that affect how I absorb medicine.I started hormone therapy for prostate cancer less than 60 days ago and am not on abiraterone, enzalutamide, or apalutamide.My blood pressure is controlled under 160/90 mmHg with medication.I started LHRH therapy for my prostate cancer less than 60 days ago.I am not currently on any experimental treatments or other cancer therapies.I do not have HIV, chronic hepatitis B or C, or any severe illness that could affect my study participation.My kidney function, measured by creatinine clearance, is adequate.I have no cancer history except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.I don't have severe heart failure or recent serious heart problems.I am willing to stop taking bicalutamide if I join the trial.My prostate cancer diagnosis was confirmed through a biopsy.I can care for myself but may not be able to do active work.I am allergic to drugs similar to those used in the study.I have not and will not receive treatment with ketoconazole, aminoglutethimide, or enzalutamide.I've had radiotherapy for cancer spread to bone or organs and recovered from side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (talazoparib, androgen deprivation therapy)
Awards:
This trial has 2 awards, including:- Approved for 50 Other Conditions - This treatment demonstrated efficacy for 50 other conditions.
- 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.
Has the FDA given its approval to Talazoparib?
"Talazoparib has been assigned a safety rating of 2 due to its Phase 2 trial status, which indicates that while there is evidence supporting the drug's security, no such data exists for efficacy."
Answered by AI
What medical conditions can be alleviated by the use of Talazoparib?
"Talazoparib is commonly prescribed to manage superficial burns, but it's also effective at treating ulcerative colitis and viral infections like varicella-zoster virus acute retinal necrosis."
Answered by AI
Are there any present opportunities for involvement in this trial?
"Affirmative. On clinicaltrials.gov, the data implies that this research project is actively searching for patients to join in its study. It was first launched on May 4th 2021 and last modified on October 7th 2022. The trial necessitates 70 participants from a single location."
Answered by AI
What is the enrollment quota for this investigation?
"Affirmative. As per the information available on clinicaltrials.gov, this medical experiment is actively seeking participants since it was first published on May 4th 2021 and last updated October 7th 2022. 70 individuals are sought for enrolment at a single research centre."
Answered by AI
What precedent has been set with regard to Talazopaributilization in clinical studies?
"At this time, 703 Talazoparib studies are taking place with 186 of them in the final phase. Although most trials for this drug are based out of Scottsdale, Arizona, 28661 sites across the world have research devoted to it."
Answered by AI
Does this research hold any unprecedented features?
"Since 2000, AstraZeneca has sponsored the study of Talazoparib. In the year 2000 600 participants were involved in Phase 1 and approval was attained after completion. Currently there are 703 ongoing trials for this drug across 74 nations and 2512 cities."
Answered by AI
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