HC-1119 for refractory, metastatic hormone-refractory Prostate cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Royal Marsden Hospital - London, London, United Kingdom
refractory, metastatic hormone-refractory Prostate cancer+2 More
HC-1119 - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

See full description

Eligible Conditions

  • refractory, metastatic hormone-refractory Prostate cancer
  • Castration-resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for refractory, metastatic hormone-refractory Prostate cancer

Study Objectives

This trial is evaluating whether HC-1119 will improve 1 primary outcome and 4 secondary outcomes in patients with refractory, metastatic hormone-refractory Prostate cancer. Measurement will happen over the course of Week 24.

Week 24
Overall Response Rate (ORR)
Overall Survival (OS)
PSA decline of ≥50% from baseline
Radiographic Progression-free Survival (rPFS)
Safety and Tolerability (based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for refractory, metastatic hormone-refractory Prostate cancer

Trial Design

2 Treatment Groups

enzalutamide
1 of 2
HC-1119
1 of 2
Active Control
Experimental Treatment

This trial requires 430 total participants across 2 different treatment groups

This trial involves 2 different treatments. HC-1119 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

HC-1119
Drug
Oral dose of 80 mg/day
enzalutamide
Drug
Oral dose of 160 mg/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HC-1119
2017
Completed Phase 1
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 24 for reporting.

Closest Location

First Urology PSC, 101 Hospital Boulevard - Jeffersonville, IN

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:
Bone disease progression defined by PCWG3 with two or more new lesions on bone scan
Metastatic disease documented by measurable soft tissue disease by CT/MRI per RECIST 1.1 criteria. Patients are allowed to have any metastatic disease (i.e. bone metastasis) as long as they also have measurable soft tissue lesions per RECIST 1.1..
PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen agent must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 µg/L (2 ng/mL)
Age 18 or older and willing and able to give informed consent.
Histologically or cytologically confirmed adenocarcinoma of the prostate without significant and relevant neuroendocrine differentiation or small cell features, per investigator's judgment.
Ongoing ADT with a GnRH analogue, antagonist or bilateral orchiectomy (i.e., surgical or medical castration).
For patients who have not had a bilateral orchiectomy, there must be a plan to maintain effective GnRH analogue or antagonist therapy for the duration of the trial.
Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the Screening visit.
Patients receiving bisphosphonate or denosumab therapy must have been on stable doses for at least four weeks (from Day 1 visit).
Soft tissue disease progression defined by RECIST 1.1

Patient Q&A Section

What are the signs of prostate cancer?

"In general, symptoms with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) appear similar to more benign or potentially cancerous conditions such as prostatitis. Prostate-disease symptoms often involve the urinary tract, though these symptoms are nonspecific and may be indicative of prostate cancer. Physicians may be unsure whether a physical examination and PSA test for prostate cancer result in a patient being prescribed a biopsy if clinical suspicion remains low. However, clinicians must still be mindful of the signs and symptoms of prostate cancer and consider referral to urology." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"The combination of surgery, radiation, and androgen deprivation therapy remain the standard of care in the treatment of prostate cancer. There is very little evidence that alternative treatment modalities offer advantages compared to current practices." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"The study suggests that the prognosis for patients with prostate cancer is highly variable; however, the number of potential treatment cures is substantial. Based on current data, we do not support the view that all patients with prostate cancer will become incurable." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"Prostate cancer is a cancer that forms in the prostate gland and usually begins in men in their 70s. Symptoms include frequent, painful or bloody urination or painful ejaculation in more than three-quarters of men. It affects younger men and those who smoke more often than men who do not. The risk factors for prostate cancer are not well documented but are thought to include smoking and male hormone levels. Prostate cancer is usually diagnosed through a biopsy which is an examination of a sample of the prostate gland." - Anonymous Online Contributor

Unverified Answer

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

"how many people get prostate cancer a year in the United States? \nThe number of prostate cancer cases have declined since the 1970s due to the promotion and acceptance of the prostate cancer screening, particularly PSA. This change has led to the shift of the prevalence of prostate cancer from the older men to the young, of which about 10-40% of men in most of the developed countries are aged between 20 and 49. In Japan, prostate cancer prevalence among those who have been on or off androgen deprivation therapy for more than 5 years had a significant decrease in the last 19 years, while androgen-deprivation therapy decreased androgen-dependent prostate cancer prevalence even if testosterone replacement therapy was added to the existing treatment." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"There is still a lack of good evidence for environmental exposures as a cause. Identifying modifiers of the overall environmental effects is necessary to advance the understanding of prostate cancer risk. Many studies have been performed in populations with low rates of prostate cancer in whom a genetic predisposition may be more important than a lack of risk factors from lifestyle." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in hc-1119 for therapeutic use?

"Data from a recent study show the latest developments in the use of hc-1119 in the therapeutic setting and suggest it as a more effective therapeutic option." - Anonymous Online Contributor

Unverified Answer

Does hc-1119 improve quality of life for those with prostate cancer?

"hc-1119 is being used at a number of sites in a clinical trial to help improve prostate cancer patients' quality of life. The main aim of this trial is to compare the impact of hc-1119 with other available treatments for prostate cancer. In addition, the side effects will be recorded and reported to make prescribing as easy as possible. hc-1119 is injected locally. Patients receive a number of injections of the drug, usually once every week (not 2 to 4 weeks as some doctors recommend), at varying dosages. This trial will investigate whether the drug is effective for preventing deterioration of quality of life for those with prostate cancer." - Anonymous Online Contributor

Unverified Answer

Does prostate cancer run in families?

"The familial occurrence of PCa has been estimated to be 2%. However, the presence of an affected member in a kindred indicates that the family history of PCa cannot be simply discounted." - Anonymous Online Contributor

Unverified Answer

How does hc-1119 work?

"Based on the data presented above, our results provide strong evidence for an effective and selective antiandrogenic action of HC-1119 which may contribute to its ability to inhibit metastatic growth of hormone-refractory prostate tumors and metastasized tumor-derived bones." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for prostate cancer?

"Older men should be more strongly cautioned against participation in clinical trials. In general, there have been few trials where age has not been an exclusionary criterion, and older men can be offered therapeutic options that are not yet widely available." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of prostate cancer?

"The majority of cases of prostate cancer have no clear etiology. However, a large proportion of prostate cancers seem to be linked to a prior history of exposure to environmental factors." - Anonymous Online Contributor

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