Poly-ICLC (Cohort B) for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Mount Sinai, New York, NY
Prostate Cancer+1 More
Poly-ICLC (Cohort B) - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a combination of immunotherapy drugs may help treat prostate cancer.

See full description

Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms
  • Metastatic Castration-resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Poly-ICLC (Cohort B) will improve 1 primary outcome and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of At 12 months.

At 12 months
Overall survival (OS) at 12 months
At 9 months
Disease control rate
Up to 2.5 years
Incidence and severity of adverse events
Objective response rate (ORR)
Overall survival (OS)
Radiographic progression-free survival (rPFS)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

3 Treatment Groups

No Control Group
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab

This trial requires 45 total participants across 3 different treatment groups

This trial involves 3 different treatments. Poly-ICLC (Cohort B) is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
Cohort A: NKTR-214 + Nivolumab
Cohort C: CDX-301 + INO-5151 + Nivolumab

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2.5 years for reporting.

Closest Location

Mount Sinai - New York, NY

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
We recommend a fresh pre-treatment biopsy of a metastatic tumor lesion that has not previously been irradiated show original
If a pre-treatment biopsy is not medically feasible, a tumor specimen in a paraffin block (preferred) or at least 10 slides containing unstained, freshly cut, serial sections must be provided. show original
In order to participate in the study, all participants must provide consent for their pre-treatment biopsy to be archived. show original
The patient must be willing to have tumor biopsies during treatment if it is medically feasible. show original
The patient has received prior therapy with an androgen receptor signaling inhibitor (abiraterone, enzalutamide, apalutamide) and has progressed on that therapy. show original
In order to participate in this study, participants must stop taking antiandrogen medication (such as bicalutamide, flutamide, and nilutamide) for at least 4-6 weeks and have no evidence of PSA decline after the washout period. show original
At least 6 weeks must elapse between the time bicalutamide is discontinued and the start of radiation therapy. show original
between these 2 agents Flutamide and nilutamide should not be taken at the same time and there should be a four-week washout period between the two medications. show original
The person has prostate cancer that has spread and is resistant to treatment that lowers testosterone levels to 50 ng/dL or less. show original
The progression of prostate cancer can be classified using the PCWG3 criteria. show original

Patient Q&A Section

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

What are common treatments for prostate cancer?

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Treatment plans for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) should focus on high risk disease due to the risks posed by radical prostatectomy (radical prostatectomy is the treatment of choice for those with intermediate risk prostate cancer), but with conservative local treatment options given the risks and benefits involved and the limited life expectancy. The benefits of androgen ablation and radiotherapy remain undefined.

Unverified Answer

What causes prostate cancer?

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The role of infectious agents triggering cancers of the lung and prostate is still being debated. The risk of prostate cancer has been linked to occupational exposure to asbestos, which is known to cause lung cancer. Although the relation between the prostate and other chronic infectious diseases is unclear, current scientific evidence does not support a role for bacterial or viral infections as causative factors.

Unverified Answer

Can prostate cancer be cured?

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Prostate cancer cannot be cured. Although the tumour may be killed, this is not always the case. Although some patients have no symptoms, others may have symptoms which are unimportant. Symptoms can be reduced or eliminated by a variety of means and patients should always be treated to the best of their ability. The likelihood of death varies significantly amongst patients, and so is the treatment they receive. These data need to be carefully examined in clinical trials and other studies, to produce realistic and practical treatments. Copyright © 2008 John Wiley & Sons, Ltd.

Unverified Answer

What is prostate cancer?

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Prostate cancer is the major cancer of the prostate gland, and the third leading cause of cancer related death in men. Prostate cancer is a heterogeneous disease that is characterised by its cellular origin, heterogeneity, and heterogeneity in the disease phenotype. It remains a challenge for the identification of biomarker and biological targets in prostate cancer.

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How many people get prostate cancer a year in the United States?

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The combined incidence of all forms of invasive cancer of the prostate, lung, colo-pancreas, and breast, and bladder for the year 1999 in the U.S. is 476,000 and that of prostate cancer (combined forms) is 124,000 which is 4.2% of all cancers. This equals the combined incidence of all forms of lung cancer, colon-pancreas cancer, and breast cancer a year in the United States.

Unverified Answer

What are the signs of prostate cancer?

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Most men over 75 years of age can see the signs of progressive enlargement of the prostate, and may want to have their prostate monitored.

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What is the primary cause of prostate cancer?

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The primary cause of prostate cancer is thought to be environmental factors in some men and genetic factors in others. The association of prostate cancer with chronic inflammation, chronic exposure to xylenes such as wood preservatives (such as aromatic solvents and styrene monomer), and the association of prostate cancer with a family history of the disease suggests a common etiology that involves some combination of environmental cause, genetic cause, and individual risk factors. Because prostate cancer is associated with a number of occupational exposures, studies have evaluated the relationship between occupational exposures and prostate cancer. However, a causal relationship between prostate cancer and most occupational exposures has not been established. Occupational exposure to some agents, including benzene, have been shown to worsen urinary tract inflammation.

Unverified Answer

What is the survival rate for prostate cancer?

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Although mortality is a serious problem for men diagnosed with prostate cancer, they may have a good prognosis when treated in hospitals with a high number of prostate cancer patients. It seems that the rate of mortality is higher in patients who receive treatment using the “wait and see” approach.

Unverified Answer

Has poly-iclc (cohort b) proven to be more effective than a placebo?

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Cohort B of the MRC2-trial was found to be more effective than placebo for lowering prostate-specific antigen level. The combination of 4 mg tamsulosin plus placebo or 4 mg tamsulosin plus 40 mg poly-Iclc was also more effective than placebo and 4 mg tamsulosin only in lowering prostate-specific antigen. It is suggested that these treatments should be further evaluated in a placebo-controlled study.

Unverified Answer

Is poly-iclc (cohort b) typically used in combination with any other treatments?

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The benefit of adding androgen deprivation therapy to brachytherapy in men with localized prostate cancer appears to be modest; but, there were no specific adverse prognostic characteristics associated with combined radiation therapy.

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What are the latest developments in poly-iclc (cohort b) for therapeutic use?

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There is an increasing amount of clinical and laboratory data supporting the role of omega-3 PUFAs in suppressing prostate cancer tumors. Additionally, there is an increasing amount of clinical work demonstrating the ability of omega-3 PUFA's to help reverse prostate cancer cell growth and the development of a more aggressive form of the disease.

Unverified Answer

How does poly-iclc (cohort b) work?

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The data suggest that poly-aciclc (Cohort B) does not have a protective effect against [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). The use of the test does not result in a reduction in radical prostatectomy rates for prostate cancer.

Unverified Answer
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