FOR46 for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Prostate Cancer+2 More
FOR46 - Biological
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug that binds to a protein expressed in many cancers can improve the response to a drug that targets a protein expressed in many cancers.

See full description

Eligible Conditions

  • Prostate Cancer
  • Metastatic Castration-resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether FOR46 will improve 3 primary outcomes and 7 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to 3 weeks.

Up to 2 years
Composite response rate (CRR) (Phase 2)
Frequency of treatment-related, adverse events (AE)
Median duration of objective response
Median overall survival survival.
Median radiographic progression-free survival
Median time to PSA progression
Objective response rate (ORR)
Proportion of participants with a greater than or equal to 50% change in PSA (PSA50)
Up to 3 weeks
Maximally tolerated dose (MTD) (Phase 1b)
Number of participants with Dose-Limiting Toxicities (Phase 1b)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Dose Expansion
1 of 2
Does Escalation
1 of 2
Experimental Treatment

This trial requires 36 total participants across 2 different treatment groups

This trial involves 2 different treatments. FOR46 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Dose ExpansionParticipants will receive a lead-in treatment period of enzalutamide monotherapy for 14 days (day -14 to day -1), followed by addition of FOR46 on Cycle 1 Day 1, at the maximum tolerated dose (MTD) as determined in Phase 1b. If participants are on enzalutamide at the time of study entry, and remain on continuous dosing at 160 mg daily, the lead-in treatment period will not be required. Prophylactic Pegfilgrastim (G-CSF) will also be administered on Day 2 during all treatment cycles.
Does EscalationApproximately 3 dose levels of FOR46 will be evaluated. Participants will receive a lead-in treatment period of enzalutamide monotherapy for 14 days (day -14 to day -1), followed by addition of FOR46 on Cycle 1 Day 1. If participants are on enzalutamide at the time of study entry, and remain on continuous dosing at 160 mg daily, the lead-in treatment period will not be required. Prophylactic Pegfilgrastim (G-CSF) will also be administered on Day 2 during all treatment cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved
Pegfilgrastim
2006
Completed Phase 3
~4180
FOR46
2019
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

University of California, San Francisco - San Francisco, CA

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:
The individual has progressive cancer that has gotten worse despite treatment with one or more medications that block androgen signals show original
People who want to participate in this study must be willing to have a biopsy of any metastatic tumors they may have show original
No other systemic anti-cancer therapies must have been administered within 14 days or 5 half-lives of the study drug, whichever is shorter show original
No prior chemotherapy for the treatment of metastatic castration-resistant prostate cancer show original
The patients in the study must be evaluated to see if they meet the requirements for the study's main goal, which is a composite response show original
An individual has an Eastern Cooperative Oncology Group (ECOG) performance status of <= 1 if he or she has a Karnofsky performance status of >= 70 percent. show original
The study found that disease progression by PCWG3 criteria at study entry was very low. show original
Histologically confirmed metastatic prostate adenocarcinoma.
Castrate levels of testosterone will be required at the start of the study show original
Age >=18 years.

Patient Q&A Section

What is the average age someone gets prostate cancer?

"Based on this analysis, the majority of PCa cases are diagnosed at ages 60 years or older. This fact suggests that prostate cancer prevention programs should focus on men aged 60 years or older. Furthermore, the fact that half of PCa cases were diagnosed at ages 55 or younger indicates that men of this age group have many more options for prevention and treatment than men over 60 years old." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"Patients with prostate cancer receive a multitude of treatment options. Consideration of many factors, including age, comorbidities, and health issues, is required before selecting the best treatment option." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"Data from a recent study shows that adjuvant treatment of localized prostate cancer can improve survival rates. Chemotherapy appears to increase survival compared to surgery alone. Preoperative brachytherapy does not seem to have an influence on survival rate. Patients treated with hormonal therapy and brachytherapy did not achieve any further improvement in survival." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"The number of prostate cancers diagnosed each year is expected to rise over the next few years. In this article, we discuss the current knowledge about prostate cancers, including its symptoms, aggressiveness, treatment and prognosis. We also describe how current technologies are being applied to establish expectations for the future." - Anonymous Online Contributor

Unverified Answer

Has for46 proven to be more effective than a placebo?

"Findings from a recent study demonstrates the efficacy of tamsulosin as an add-on treatment with finasteride in improving the urinary symptoms of BPH. In addition, it was found that regardless of the baseline severity of the prostate disease (i.e. nocturia, urgency/incontinence), tamsulosin improved the quality of life in all patients." - Anonymous Online Contributor

Unverified Answer

Is for46 safe for people?

"Recent findings suggests that there are no differences between the risk of death or major adverse events associated with using F46 compared to conventional treatment. Recent findings support current guidelines recommending that F46 should be offered when treating early stage prostate cancer in men with normal functioning kidneys who receive radiotherapy alone." - Anonymous Online Contributor

Unverified Answer

What is the latest research for prostate cancer?

"Current research includes drug discovery, biomarker development, and treatment strategies for prostate cancer. At the same time, the literature contains many articles on the genetics of prostate cancer." - Anonymous Online Contributor

Unverified Answer

How does for46 work?

"Results from a recent paper indicate that treatment with for46 reduces or prevents development of late effects after radiation therapy for prostate cancer. More importantly, it may also provide a means of reducing the side effects of radiotherapy itself. This trial was registered at clinicaltrials.gov as NCT00441848." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for prostate cancer?

"Patients with low risk disease may benefit from adjuvant therapies. However, for patients requiring curative therapy it remains unclear whether they have an improved survival. Although many patients will benefit from adjuvant therapy, only a minority are likely to receive this treatment because most patients undergoing radical prostatectomy do not require it. Data from a recent study suggests that informing these patients about the uncertainties associated with their decision would help them make a more informed choice." - Anonymous Online Contributor

Unverified Answer

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

"The number of new PCa cases detected annually in the U.S. has increased since 1990 and continues to grow each year. This supports the hypothesis that there is an increasing incidence rate for PCa and an increasing prevalence of PCa. Furthermore, age at diagnosis appears to be decreasing over time." - Anonymous Online Contributor

Unverified Answer

What is for46?

"Based on these findings, it appears that 46,XY karyotype should be considered when evaluating patients with FHH, especially in situations where a child's sex assignment is contemplated and in patients who present with signs of hypogonadism; however, the addition of a routine gonadal assessment is not necessary." - 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.
See if you qualify for this trial
Get access to this novel treatment for Prostate Cancer by sharing your contact details with the study coordinator.