CLINICAL TRIAL

11C-YJH08 for Prostate Cancer

Metastatic
Recruiting · 18+ · Male · San Francisco, CA

This study is evaluating if PET imaging using 11C-YJH08 can be useful for detecting certain cell receptor expression in tumor cells in patients with prostate cancer that has spread to other parts of the body (metastatic).

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About the trial for Prostate Cancer

Eligible Conditions
Castration-Resistant Prostate Carcinoma · refractory, metastatic hormone-refractory Prostate cancer · Carcinoma · Stage IV Prostate Cancer AJCC v8 · Stage IVB Prostate Cancer AJCC v8 · Prostatic Neoplasms · Stage IVA Prostate Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. 11C-YJH08 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 and are in the first stage of evaluation with people.

Experimental Group 1
Computed Tomography
PROCEDURE
+
Positron Emission Tomography
PROCEDURE
+
Magnetic Resonance Imaging
PROCEDURE
+
11C-YJH08
DRUG
Experimental Group 2
Computed Tomography
PROCEDURE
+
Positron Emission Tomography
PROCEDURE
+
Magnetic Resonance Imaging
PROCEDURE
+
11C-YJH08
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3460
Positron Emission Tomography
2019
Completed Phase 2
~2950
Magnetic Resonance Imaging
2017
Completed Phase 2
~1120

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
COHORT A: Histologically-confirmed progressive metastatic castration resistant prostate cancer with evidence of progression by the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) on current enzalutamide or apalutamide treatment at the time of study entry
The subject is able and willing to comply with study procedures and provide signed and dated informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Age 18 years or older at the time of study entry
COHORT B: Metastatic castration-resistant prostate cancer with planned treatment with enzalutamide or apalutamide as next line of systemic therapy at the time of study entry. Patients must not have received first dose of enzalutamide or apalutamide prior to baseline 11C-YJH08 PET
Patients in Cohort A and B must have serum testosterone level < 50 ng/dL and must remain on luteinizing hormone-releasing hormone (LHRH) analog therapy for the duration of study participation, in the absence of prior bilateral orchiectomy
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR estimated creatinine clearance > 50 ml/min
Total bilirubin =< 1.5 x ULN
Hemoglobin >= 8.0 g/dL
Platelet count >= 50,000/microliter
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 24 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether 11C-YJH08 will improve 3 primary outcomes and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to day 1 follow-up.

Sensitivity of 11C-YJH08 PET in metastatic lesion detection (Cohort A only)
UP TO DAY 1 FOLLOW-UP
Will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including computed tomography or magnetic resonance imaging of the chest/abdomen/pelvis and whole body bone scan.
UP TO DAY 1 FOLLOW-UP
Incidence of adverse events
UP TO DAY 1 FOLLOW-UP
As recorded by Common Terminology Criteria for Adverse Events Version 5.0 criteria and organ dosimetry of 11C-YJH08 PET. Will be descriptively reported.
UP TO DAY 1 FOLLOW-UP
Association between baseline uptake on 11C-YJH08 PET and objective response rate (Cohort B only)
UP TO 24 MONTHS
Will be compared between dichotomized groups using the chi-squared test.
UP TO 24 MONTHS
Association between baseline uptake on 11C-YJH08 PET with progression-free survival (Cohort B only)
UP TO 24 MONTHS
The log rank test will be used to compare progression-free survival between dichotomized subgroups.
UP TO 24 MONTHS
Association between baseline uptake on 11C-YJH08 PET with prostate specific antigen (PSA50) response (Cohort B only)
UP TO 24 MONTHS
Will be compared between dichotomized groups using the chi-squared test.
UP TO 24 MONTHS
Mean percent change from baseline at the time of progression in standardized uptake value (SUV)max-ave on paired 11C-YJH08 PET per-lesion (Cohort B only)
UP TO 24 MONTHS
Will be descriptively reported along with range on a per-lesion basis. Wilcoxon signed rank test will be used to compare the follow up to baseline PET scan values at lesion level.
UP TO 24 MONTHS
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Patient Q & A Section

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

Does prostate cancer run in families?

Findings from a recent study suggest that sporadic PCa has a familial component. PCa could be involved in many genes. We hypothesize a genetic model for BRCA1 mutation carriers, which might explain the age at onset and the familial occurrence of PCa and warrant further investigation.

Anonymous Patient Answer

Is 11c-yjh08 safe for people?

Although 11C-YJH08 was well tolerated and associated with no significant adverse events, this study did not show superiority over placebo on primary outcomes, and thus merits further investigation.

Anonymous Patient Answer

Have there been any new discoveries for treating prostate cancer?

Despite the large number of published research articles on treatment of prostate cancer, many questions remain unanswered. There are no data on the cost effectiveness of these treatments, nor have they been proven effective in all aspects of the disease. A better understanding of the biology of prostate cancer can lead to improved treatment options.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

To our knowledge, this is the largest database study to report average age of onset of PCa. The findings suggest that the mean age at time of diagnosis of PCa increased steadily from 1990 to 2006; however, the age distribution remained skewed toward younger ages, with 7.4% of all diagnoses occurring at age <40 years.

Anonymous Patient Answer

What is the latest research for prostate cancer?

There are many topics in the biomedical sciences that have benefited from the development and application of advanced technologies and concepts. Novel approaches that aim at identifying early and aggressive forms of prostate cancer will hopefully lead to better outcomes for patients with this disease. Scientists have also been able to identify possible biomarkers that may guide the diagnosis and treatment of prostate cancer. Prospective trials evaluating innovative diagnostic tools and therapies are now being conducted on a regular basis.

Anonymous Patient Answer

What are common treatments for prostate cancer?

The use of AAS for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) prevention should be discouraged because it does not improve survival but increases the rate of non-organ-confined cancers. Radical therapy is preferable to watchful waiting ± salvage radiation therapy after failure of radical therapy.

Anonymous Patient Answer

How does 11c-yjh08 work?

Findings from a recent study suggest that yjh08 exerts its antitumoral properties via inhibition of angiogenesis, potentiation of apoptosis and modulation of cell cycle progression. Findings from a recent study highlights the therapeutic potential of 11C-yjh08 in urological malignancies.

Anonymous Patient Answer

What does 11c-yjh08 usually treat?

The treatment outcome of patients with T1N0M0 prostate cancer was similar to that observed for patients with locally advanced prostate cancer treated with standard therapy including external beam radiotherapy and/or brachytherapy. Recent findings suggest that 11c-yjh08 can be proposed as a therapeutic option for patients with localized prostate cancer.

Anonymous Patient Answer

How quickly does prostate cancer spread?

Recent findings suggest that prostate cancer may be more likely to spread if it first arises in the peripheral zone rather than the transitional zone. Further studies are needed to determine whether this finding can be exploited to improve treatment strategies.

Anonymous Patient Answer

What are the common side effects of 11c-yjh08?

11C-yjh08 is well tolerated with clinically relevant adverse events. For example, headache occurred in 25% of patients who received 11C-yjh08; however, this does not appear to have resulted in any serious consequences in those patients. Further studies are required to clarify the full range of adverse events associated with 11C-yjh08.

Anonymous Patient Answer

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

• About 1 in 6 men will develop prostate cancer during their lifetime. • About 1 in 10 men will die of prostate cancer. • Rates differ considerably among racial groups. • Men are more likely to develop prostate cancer at younger ages, in higher socioeconomic groups, and in cities.

Anonymous Patient Answer
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