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Hormone Therapy
Apalutamide + Abiraterone for Prostate Cancer (PANTHER Trial)
Phase 2
Waitlist Available
Led By Daniel J. George, MD
Research Sponsored by Daniel George, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A minimum of 4 weeks from any major surgery prior to start of study drug.
Karnofsky performance status ≥ 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks, up to 4 years
Awards & highlights
PANTHER Trial Summary
This trial is a non-comparative pilot study of apalutamide and abiraterone acetate in African American and Caucasian men with mCRPC. The study's primary goal is to prospectively estimate the median PFS of the two groups of men. Secondary objectives include: PSA kinetics, radiographic assessments, safety and tolerability, and incidence of hypertension in the two populations.
Who is the study for?
This trial is for African American and Caucasian men with metastatic castrate-resistant prostate cancer. Participants must be over 18, have a life expectancy of at least 12 months, and be able to take oral medication. They should not have had certain previous treatments or conditions that could interfere with the study drugs or pose risks.Check my eligibility
What is being tested?
The trial tests apalutamide, abiraterone acetate, and prednisone in treating prostate cancer. It's an open-label study where both African American and Caucasian men receive the same treatment to compare progression-free survival (PFS) rates, PSA response, radiographic assessments, safety, and tolerability.See study design
What are the potential side effects?
Potential side effects include high blood pressure; liver issues; immune system changes leading to increased infection risk; gastrointestinal disorders affecting drug absorption; hormonal imbalances affecting adrenal or pituitary function; allergic reactions; seizures in predisposed individuals.
PANTHER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
It has been at least 4 weeks since my last major surgery.
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I am able to care for myself but may not be able to do active work.
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I can take pills without crushing or chewing them and on an empty stomach.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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My kidney function is normal or only mildly reduced.
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My prostate cancer is confirmed and not mainly neuroendocrine or small cell type.
Select...
I am continuing hormone therapy for my cancer, unless I've had both testicles surgically removed.
Select...
My prostate cancer is not responding to hormone therapy.
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My PSA levels have been rising consistently.
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I am a man aged 18 or older.
PANTHER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 12 weeks, up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks, up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median radiographic progression free survival (PFS)
Secondary outcome measures
Change in PSA response
Change in radiologic response rates
Number of adverse events
+3 moreSide effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
PANTHER Trial Design
2Treatment groups
Experimental Treatment
Group I: CaucasianExperimental Treatment3 Interventions
Group II: African AmericanExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARN-509
2013
Completed Phase 2
~110
Abiraterone Acetate
2015
Completed Phase 4
~1880
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
Daniel George, MDLead Sponsor
7 Previous Clinical Trials
161 Total Patients Enrolled
3 Trials studying Prostate Cancer
84 Patients Enrolled for Prostate Cancer
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,425 Total Patients Enrolled
10 Trials studying Prostate Cancer
1,250 Patients Enrolled for Prostate Cancer
Daniel J. George, MDPrincipal InvestigatorDuke Cancer Institute
2 Previous Clinical Trials
39 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms due to an irregular heartbeat.It has been at least 4 weeks since my last major surgery.I have had chemotherapy or biological therapy for prostate cancer, but not within the last 2 weeks.I have previously been treated with specific prostate cancer medications.I cannot take steroids like prednisone due to an infection or other medical condition.My prostate cancer is of the small cell type.I haven't had serious heart issues or blood clots in the last 6 months.I am not taking strong medications that increase the breakdown of abiraterone.I am not taking any sensitive medications with abiraterone or can adjust their doses.The investigator thinks that you have a condition that makes you ineligible to participate in this trial.I am able to care for myself but may not be able to do active work.I have a condition or history that might increase my risk of seizures.My liver is not working well (moderate to severe issues).I can take pills without crushing or chewing them and on an empty stomach.I do not have an active infection like HIV, hepatitis, or chronic liver disease.I take more than 5mg of prednisone or similar medication twice a day for a chronic condition.I haven't taken azole anti-fungal drugs in the last 4 weeks.I stopped taking hormone therapy for cancer at least 2 weeks ago.It's been at least 2 weeks since I last had sipuleucel-T or radiation therapy.I am allergic to abiraterone, apalutamide, prednisone, or their ingredients.I have cancer spread to my liver or other organs causing symptoms.I have stomach or intestine problems that could affect medicine absorption.I have cancer that has spread to my brain.I have been treated with ketoconazole for my prostate cancer for more than a week.I stopped taking any seizure-risk increasing meds 4 weeks ago.My blood pressure is controlled with medication.My fasting blood sugar is 200 mg/dL or higher, indicating poorly controlled diabetes.I have had issues with my pituitary or adrenal glands.My blood tests show normal white blood cells, platelets, and hemoglobin levels.My kidney function is normal or only mildly reduced.My prostate cancer is confirmed and not mainly neuroendocrine or small cell type.My scans show cancer has spread, meeting specific criteria.I am continuing hormone therapy for my cancer, unless I've had both testicles surgically removed.My prostate cancer is not responding to hormone therapy.My PSA levels have been rising consistently.You identify yourself as either African American or Caucasian.I'm sorry, but that criterion is incomplete. Please provide me with the full criterion so that I can summarize it for you in simple language.I am not using herbal products that can lower PSA levels.I have a cancer, other than non-melanoma skin cancer, with a high chance of returning within 2 years.I am a man aged 18 or older.
Research Study Groups:
This trial has the following groups:- Group 1: African American
- Group 2: Caucasian
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.
What does the FDA have to say about Prednisone?
"While Phase 2 trials don't have data supporting efficacy, there is some evidence of safety, so we've given it a score of 2."
Answered by AI
Where are the different sites that this experiment is taking place?
"The 15 total clinical sites for this study are UNC Lineberger Cancer Center in Chapel Hill, North carolina; Maria Parham Hospital in Henderson, Louisiana; Tulane University in New Orleans, South carolina as well as 14 other locations."
Answered by AI
Are patients currently being enrolled in this research?
"Unfortunately, this particular clinical trial is not taking any more patients at the moment. According to the website clinicaltrials.gov, which last updated on February 5th, 2022, this study was initially posted on July 10th, 2017. However, there are 1,769 other trials that are currently recruiting candidates."
Answered by AI
Why do people usually take Prednisone?
"Prednisone can help alleviate symptoms caused by thyroiditis, prostate cancer non-metastatic, and ulcerative colitis."
Answered by AI
Could you direct me to other research that has been done on Prednisone?
"As of now, there are 403 ongoing clinical trials studying Prednisone. Out of those, 110 have reached Phase 3. Although the majority of these research studies are based in Duarte, California, 19016 different locations worldwide are running Prednisone-based trials."
Answered by AI
How many individuals are enrolled in this research project?
"This particular clinical trial is not seeking any more participants at the moment. It was initially posted on July 10th, 2017 and edited for the last time on February 5th, 2022. However, there are 1366 other trials currently underway that are actively recruiting patients with prostate cancer and 403 studies involving Prednisone still have open enrollment."
Answered by AI
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