RYZ711 Diagnostic Platform for Prostate Cancer

AA
RC
Overseen ByRayzeBio Clinical Trials
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: RayzeBio, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new diagnostic tool, RYZ711, to better understand prostate cancer in men. It uses a special imaging technique, PET/CT, to observe cancer behavior. The trial includes three groups: those with high-risk localized cancer, those whose cancer has returned after treatment, and those with metastatic cancer. Men diagnosed with prostate cancer who have specific plans for further treatment or imaging might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to benefit from this innovative diagnostic approach.

What prior data suggests that the RYZ711 diagnostic platform is safe for prostate cancer imaging?

Research has shown that RYZ711, a substance used in PET/CT scans, is still under evaluation for safety in humans. As the study is in its early stages, limited information is available about its safety. Researchers are currently focused on ensuring safety before proceeding to larger studies, closely monitoring for any side effects or unexpected reactions.

While specific safety data from past studies on RYZ711 is not available, reaching this stage indicates it has passed some initial safety checks. Participants should discuss any concerns with the research team, who can explain potential side effects and the safety measures in place during the study.12345

Why are researchers excited about this trial?

Researchers are excited about the RYZ711 diagnostic platform for prostate cancer because it offers a cutting-edge approach to detecting and monitoring the disease. Unlike current standard treatments, which often involve invasive procedures and generalized therapies, RYZ711 utilizes advanced molecular imaging techniques that could provide more precise and earlier detection of high-risk localized prostate cancer, biochemical recurrence, and metastatic disease. This platform aims to personalize treatment plans by accurately assessing the cancer's progression and response, potentially leading to better outcomes and fewer side effects. By targeting specific cancer markers, RYZ711 could revolutionize the way clinicians approach prostate cancer management, offering a more tailored and effective strategy.

What evidence suggests that the RYZ711 diagnostic platform is effective for prostate cancer?

Research has shown that RYZ711, which participants in this trial will receive, could aid in diagnosing prostate cancer. Although limited data exists on RYZ711's effectiveness, it employs PET/CT scans to locate cancer in the prostate. PET/CT scans use a special dye to highlight areas of potential cancer activity. Early results suggest that PET/CT scans can identify cancer cells more accurately than traditional methods. This accuracy may help doctors detect prostate cancer earlier, which is crucial for successful treatment.678910

Are You a Good Fit for This Trial?

This trial is for men with confirmed prostate cancer. Participants must be well enough to carry out daily activities, need a PSMA PET/CT scan, and fit into one of these groups: newly diagnosed higher-risk cases, those whose PSA levels are rising after treatment, or those with advanced disease that has spread.

Inclusion Criteria

My PSA levels are rising after I finished prostate cancer treatment.
Planned or scheduled PSMA PET/CT scan
I am able to care for myself and do light activities.
See 3 more

Exclusion Criteria

I have reduced kidney, heart, or liver function.
My prostate cancer is neuroendocrine, sarcomatoid, or spindle cell type.
I have cancer that has spread, and it is not prostate cancer.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo RYZ711 PET/CT imaging to evaluate safety, tolerability, and diagnostic performance

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • RYZ711

Trial Overview

The study is testing the safety and effectiveness of a new imaging agent called RYZ711 used during PET/CT scans to detect prostate cancer. The goal is to see how well it works compared to standard methods in different patient groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Cohort 3 - RYZ711Experimental Treatment2 Interventions
Group II: Cohort 2 - RYZ711Experimental Treatment2 Interventions
Group III: Cohort 1 - RYZ711Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

RayzeBio, Inc.

Lead Sponsor

Trials
6
Recruited
540+

Citations

Significant impact of biochemical recurrence on overall ... - PMC

Significant impact of biochemical recurrence on overall mortality in patients with high‐risk prostate cancer after carbon‐ion radiotherapy ...

Optimizing the Management of High-Risk, Localized Prostate ...

After RP for high-risk disease, 10-year outcomes reported by Loeb et al. [23] include a 32% rate of biochemical recurrence, 16% rate of metastasis, and 8% rate ...

Are biochemical recurrence outcomes similar after radical ...

EBRT patients with similar nomogram-predicted 5Y-PFP appear to have a significantly increased risk of PCSM compared with those treated by RP.

Comparison of biochemical recurrence in prostate cancer ...

The 5-year BCR free survival rate was also significantly different; 74.2% for the RP group and 27.7% for the RT group (log-rank test p=0.032) (Fig. 2). Fig. 2.

Comparison of biochemical recurrence in prostate cancer ...

We evaluated the biochemical recurrence (BCR) of prostate cancer patients treated by radical prostatectomy (RP) or radiotherapy (RT).

Treating Biochemical Recurrence of Prostate Cancer with ...

A prostate cancer expert reviews the treatment approach in the presented case of biochemical recurrence of prostate cancer with high-volume ...

Radical prostatectomy for high-risk prostate cancer

Radical prostatectomy is feasible in high-risk prostate cancer patients, only if they have a pathologically organ-confined disease.

Statins Prevent Biochemical Recurrence of Prostate ...

Approximately 45.7% approximately 40% reduction in risk of biochemical recurrence at a median follow-up time of 51.2 months (HR 0.599, p< 0.05).

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28070166/

Biochemical Recurrence Prediction in High-Risk Prostate ...

High-risk prostate cancer patients with 1 NCCN high-risk factor can be considered for robot-assisted radical prostatectomy treatment only.