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Hormone Therapy

Androgen Depletion + Targeted Therapies for Prostate Cancer

Q: To what degree has Abiraterone Acetate been proven to be secure for patient use?

<p>Our team at Power rated <a href="https://www.withpower.com/clinical-trials/abiraterone-acetate">Abiraterone acetate</a>'s safety a 2, due to the number of Phase 2 trials that had been conducted and results collected for its security. However, there is currently no data affirming efficacy.</p>

Phase 2

Waitlist Available

Led By Christopher Logothetis, 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 12 weeks

Awards & highlights

Study Summary

This trial is for men with prostate cancer that has spread to other parts of the body. You will be given prednisone, abiraterone acetate, sunitinib malate, and dasatinib. These drugs are all FDA-approved, but their use in prostate cancer and in combination with each other is still being researched. Up to 180 patients will be enrolled at MD Anderson.

Who is the study for?

This trial is for men aged 18+ with advanced prostate cancer that has spread, who are castrated (surgically or medically) with low testosterone levels. They must have tried androgen deprivation without success and can't be on certain medications. Good physical condition, organ function, and blood counts are required. Men must agree to use contraception if their partner could become pregnant.Check my eligibility

What is being tested?

The study tests the combination of Abiraterone Acetate and Prednisone with either Sunitinib or Dasatinib in treating metastatic prostate cancer. These drugs are approved for other cancers but their use together in prostate cancer is experimental. Up to 180 patients at MD Anderson will participate.See study design

What are the potential side effects?

Possible side effects include fatigue, liver issues, changes in blood pressure and heart rhythm, digestive problems, risk of infection due to immune system suppression, skin reactions from drug interactions, and potential bleeding disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Final Failure Time

Side effects data

From 2022 Phase 2 trial • 26 Patients • NCT03043807

81%

fatigue

38%

hot flashes

38%

neuropathy

19%

alopecia;

19%

dysgeusia

15%

hiccups

15%

nausea

15%

skin alterations

12%

diarrhea

12%

gastritis

12%

edema (lower extremity)

12%

rash

12%

constipation

anxiety

xerosis

hematochezia

elevated ALT

xerostomia

cough

elevated AST

general body aches

pruritis

nail discoloration

fever

anemia

epistaxis

infusion related reaction

neutropenia

neutropenic fever

gastrointestinal reflux

pain (bilateral legs)

mucositis

pain (joint);

anorexia

nail ridging

weight gain

hematuria

urinary tract obstruction

oral candidiasis

insomnia

depression

dyspnea

arthritis

pain (pelvis)

memory impairment

heartburn

100%

80%

60%

40%

20%

Study treatment Arm

Chemohormonal and Definitive Therapy After Prostatectomy

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 2: AP + DasatinibExperimental Treatment3 Interventions

AP (Abiraterone Acetate + Prednisone) Plus Dasatinib; Randomized from AP group to receive Dasatinib if disease worsens. Assignment to crossover group AP + Sunitinib with further disease progression.

Group II: Group 1: AP + SunitinibExperimental Treatment3 Interventions

AP (Abiraterone Acetate + Prednisone) Plus Sunitinib; Randomized from AP group to receive Sunitinib if disease worsens. Assignment to crossover group AP + Dasatinib with further disease progression.

Group III: Abiraterone Acetate + Prednisone (AP)Experimental Treatment2 Interventions

Abiraterone Acetate at 1000 mg orally each day, given in combination with 5 mg of Prednisone orally twice daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone Acetate

2015

Completed Phase 4

~1880

Sunitinib

2014

Completed Phase 3

~4380

Prednisone

2014

Completed Phase 4

~2370

Dasatinib

2012

Completed Phase 3

~2320

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,591 Total Patients Enrolled

95 Trials studying Prostate Cancer

29,550 Patients Enrolled for Prostate Cancer

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,324 Total Patients Enrolled

41 Trials studying Prostate Cancer

5,257 Patients Enrolled for Prostate Cancer

Janssen Scientific Affairs, LLCIndustry Sponsor

159 Previous Clinical Trials

580,328 Total Patients Enrolled

10 Trials studying Prostate Cancer

1,153 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01254864 — Phase 2

Prostate Cancer Research Study Groups: Group 1: AP + Sunitinib, Group 2: AP + Dasatinib, Abiraterone Acetate + Prednisone (AP)

Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT01254864 — Phase 2

Abiraterone Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01254864 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions can Abiraterone Acetate be used to treat?

"Abiraterone acetate is a viable clinical intervention for thyroid cancers, lupus erythematosus and other forms of thyroiditis."

Answered by AI

Is there an open enrollment period currently in effect for this research project?

"As per records on clinicaltrials.gov, this specific medical trial is not in need of participants at the moment. The study was posted on March 16th 2011 and last updated December 6th 2022, however there are 1779 other trials that currently require enrolment."

Answered by AI

To what degree has Abiraterone Acetate been proven to be secure for patient use?

"Our team at Power rated Abiraterone acetate's safety a 2, due to the number of Phase 2 trials that had been conducted and results collected for its security. However, there is currently no data affirming efficacy."

Answered by AI

What is the capacity of this research trial?

"Unfortunately, this investigation is not presently taking on new participants. Initially posted in March of 2011 and last updated in December 2022, it has reached the end of its recruitment period. Nonetheless, prostate cancer patients can still participate as 1326 trials are actively recruiting whilst 453 clinical studies seek subjects for Abiraterone acetate treatment."

Answered by AI

Could you provide a summary of prior research on Abiraterone Acetate?

"Currently, 453 clinical trials assessing Abiraterone acetate are ongoing with 117 of those in the third phase. The Duarte area is running several research studies involving this drug, but there are more than 23 thousand locations delivering these experiments worldwide."

Answered by AI

Recent research and studies

European Journal of CancerJournal

A Candidate Androgen Signalling Signature Predictive of Response to Abiraterone Acetate in Men with Metastatic Castration-resistant Prostate Cancer

Boukovala, Myrto, Nicholas Spetsieris, Justin A. Weldon, Alexandros Tsikkinis, Anh Hoang, Ana Aparicio, Shi-Ming Tu, et al.. 2020. “A Candidate Androgen Signalling Signature Predictive of Response to Abiraterone Acetate in Men with Metastatic Castration-resistant Prostate Cancer”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2019.12.027.

Prostate Cancer and Prostatic DiseasesJournal

Characterization of Prostate Cancer Adrenal Metastases: Dependence Upon Androgen Receptor Signaling and Steroid Hormones

Sakellakis, Minas J., Andrew W. Hahn, Sumankalai Ramachandran, Miao Zhang, Anh Hoang, Jian H. Song, Jingjing Liu, et al.. 2022. “Characterization of Prostate Cancer Adrenal Metastases: Dependence Upon Androgen Receptor Signaling and Steroid Hormones”. Prostate Cancer and Prostatic Diseases. Springer Science and Business Media LLC. doi:10.1038/s41391-022-00590-x.

clinicaltrials.govStudy

Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies

2011. "Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01254864.