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Anti-tumor antibiotic

Abiraterone + Niclosamide + Prednisone for Prostate Cancer

Q: In what ways is Prednisone typically employed therapeutically?

Prednisone is a viable therapeutic option for managing scalp structure, thyroiditis, and <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>.

Q: Are researchers still accepting volunteers for this research endeavor?

Judging by the information stored on clinicaltrials.gov, this trial is no longer actively seeking participants. It was first posted in October 2016 and last updated in February 2022; however, there are a plethora of other trials recruiting right now with over 4000 options available to potential patients.

Q: Has Prednisone been evaluated in other experiments?

Currently, there are 438 ongoing investigations into Prednisone's efficacy with 122 entering Phase 3. Although Duarte, <a href="https://www.withpower.com/clinical-trials/california">California</a> is home to many of these trials, a total of 18203 locations across the world have studies running.

Q: How many subjects are engaged in this investigation?

This trial is no longer accepting participants. It was initially posted on October 1st 2016 and the latest update came in February 23rd 2022. However, for those seeking to join a clinical study, there are 3649 studies actively enrolling individuals with <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a> and 438 trials recruiting patients taking Prednisone.

Q: To what extent is Prednisone hazardous for individuals taking it?

Prednisone received a score of 2, due to the fact that Phase 2 trials have yielded some safety data but no evidence for efficacy.

Phase 2

Waitlist Available

Research Sponsored by Mamta Parikh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable): - Progression of unidimensionally measurable disease assessed within 42 days prior to initial administration of drug - Progression of evaluable but not measurable disease assessed within 42 days prior to initial administration of drug for PSA evaluation and for imaging studies (e.g, bone scans) - Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (second [2nd] beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure - Measurable disease is not required - Patients who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drug - Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within 28 days prior to initial administration of drug - Soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; as the biology of previously irradiated tumors may be different from non-irradiated tumors, patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease - If PSA is the only indicator of disease and patients do not have any metastatic disease, PSA value must be 5.0 or higher - Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists; serum testosterone must be at castration levels (< 50 ng/dL) within 3 months prior to registration - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) - Life expectancy of greater than 6 months - Leukocytes >= 3,000/mcL - Absolute neutrophil count >= 1,500/mcL - Platelets >= 100,000/mcL - Total bilirubin within normal institutional limits - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 × institutional upper limit of normal - Creatinine =< 1.5 x institutional upper limit of normal - Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of abiraterone and PDMX1001/niclosamide administration - Ability to understand and the willingness to sign a written informed consent document

Patients must have histologically or cytologically confirmed cancer of prostate (CaP); CaP can be recurrent disease after definitive therapy (radical prostatectomy or radiation therapy) for localized CaP, or metastatic CaP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat hormone-resistant prostate cancer. The drugs may work by lowering the amount of androgen in the body or by blocking a signal that can cause prostate cancer cell growth.

Who is the study for?

Men with hormone-resistant prostate cancer, who have not had chemotherapy or radiotherapy in the last 4 weeks and have recovered from previous treatments. They must have a life expectancy over 6 months, be medically castrated with low testosterone levels, and agree to use contraception. Excluded are those with other recent cancers, brain metastases, severe illnesses that could affect study compliance or drug absorption issues.Check my eligibility

What is being tested?

The trial is testing the effectiveness of combining abiraterone acetate (lowers androgen production), niclosamide (blocks cancer cell growth signals), and prednisone (reduces inflammation) for treating hormone-resistant prostate cancer. It's a phase II trial to see how well these drugs work together.See study design

What are the potential side effects?

Possible side effects include allergic reactions similar to those caused by compounds related to abiraterone or niclosamide, gastrointestinal disturbances which may affect drug absorption like nausea or vomiting, as well as potential impacts on liver function indicated by blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My prostate cancer is confirmed by tests and may be recurrent or has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

PSA response rate

Secondary outcome measures

Incidence of dose limiting toxicity defined as any grade III non-hematologic toxicity not reversible to grade II or less within 96 hours, or any grade IV toxicity

Overall response as determined by PCWG2 criteria

Overall survival

+1 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389

98%

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

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Hypoglycemia

Dysphagia-esophageal radiation

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Stanford V)

Arm A (ABVD)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (abiraterone acetate, niclosamide, prednisone)Experimental Treatment3 Interventions

Patients receive abiraterone acetate PO QD, niclosamide PO BID and prednisone PO BID. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone Acetate

2015

Completed Phase 4

~1880

Niclosamide

2017

Completed Phase 3

~2280

Prednisone

2014

Completed Phase 4

~2370

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mamta ParikhLead Sponsor

6 Previous Clinical Trials

173 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,630 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,173 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02807805 — Phase 2

Prostate Cancer Research Study Groups: Treatment (abiraterone acetate, niclosamide, prednisone)

Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT02807805 — Phase 2

Abiraterone Acetate (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02807805 — Phase 2

Frequently Asked Questions

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

In what ways is Prednisone typically employed therapeutically?

"Prednisone is a viable therapeutic option for managing scalp structure, thyroiditis, and ulcerative colitis."

Answered by AI

Are researchers still accepting volunteers for this research endeavor?

"Judging by the information stored on clinicaltrials.gov, this trial is no longer actively seeking participants. It was first posted in October 2016 and last updated in February 2022; however, there are a plethora of other trials recruiting right now with over 4000 options available to potential patients."

Answered by AI

Has Prednisone been evaluated in other experiments?

"Currently, there are 438 ongoing investigations into Prednisone's efficacy with 122 entering Phase 3. Although Duarte, California is home to many of these trials, a total of 18203 locations across the world have studies running."

Answered by AI

How many subjects are engaged in this investigation?

"This trial is no longer accepting participants. It was initially posted on October 1st 2016 and the latest update came in February 23rd 2022. However, for those seeking to join a clinical study, there are 3649 studies actively enrolling individuals with prostate cancer and 438 trials recruiting patients taking Prednisone."

Answered by AI