The VISION study is a phase 3 research study of the investigational drug, 177Lu-PSMA-617.

The purpose of this study is to evaluate the anti-tumor and safety effects, and quality of life, of 177Lu-PSMA-617 in combination with best supportive/best standard of care compared to best supportive/standard of care alone in men with progressive, metastatic castration-resistant prostate cancer which has a protein called PSMA on the surface of the tumor cells. Approximately 750 qualifying men are expected to participate in the study.

The therapy we will be using in this study is called “radioligand therapy”. PSMA-617 is a molecule that attaches to a protein on the surface of prostate cancer cells called PSMA. A radioactive atom (Lutetium-177) is attached to PSMA-617 which then takes it directly to the prostate cancer cells. The safety profile and how well 177Lu-PSMA-617 works in relation to other treatments for prostate cancer has not been studied. The VISION study will directly compare 177Lu-PSMA-617 to those standard treatments. 177Lu-PSMA-617 is not approved for treatment of prostate cancer at this time and is still considered to be experimental treatment.

The VISION study is a prospective, randomized, open-label study. “Randomized” means that men in this study will be assigned at random (by chance alone) to one of two treatment groups. All patients in the study will receive the best standard of care decided by their physician for the kind of prostate cancer being studied. In addition, one group of men will receive the experimental treatment, 177Lu-PSMA-617 in addition to the best standard of care. The other group will still receive best standard of care that is currently available and decided by their treating physician. “Open-label” means that patients and their physicians will know which of the two treatment groups the patient is assigned. Two-thirds of the patients participating in the VISION trial will receive 177Lu-PSMA-617 and the best standard of care. One third of the patients participating in the clinical trial will receive best standard of care currently available.

All patients will be screened initially with a PSMA-targeted positron emission tomography (PET)/computed tomography (CT) scan to see if their prostate cancer has cells with a protein called PSMA on their surface. Only patients with prostate cancer that contains the PSMA protein, which is the intended target of the therapy, can participate in this study. About 85% of prostate cancer patients have this PSMA protein expressed.

Eligibility

To participate in the VISION study, you must be at least 18 years of age and have progressive metastatic castration-resistant prostate cancer.

You are potentially eligible if all the following are true, according to your treating physician:

  • Your prostate cancer progressed despite being treated with one or two courses of taxane-based chemotherapy.
  • You previously received at least one prior novel androgen-axis drug (such as abiraterone or enzalutamide) and still your cancer progressed.
  • You have at least one tumor that can be seen on a CT scan, MRI or bone scan that can be followed for response to treatment.
  • Your cancer has been defined as “PSMA-positive” by an imaging scan

You are potentially not eligible if any of the following are true:

  • You were previously treated with PSMA-targeted radioligand therapy.
  • In the previous 6 months, you were treated with radium therapy.

If you are interested in participating in the VISION study, please contact your doctor to discuss additional eligibility requirements and if this study might be appropriate for you.

VISION Treatment Schedule

Participants will receive Best Supportive/Best Standard of care as directed by their physician. 177Lu-PSMA-617 will be administered as an intravenous injection once during each six-week cycle. Because this treatment is radioactive, participants will be monitored closely after treatment as determined by their study doctor.

Common Questions and Answers

Will all patients in the study receive an approved standard therapy to treat mCRPC?

Yes. All men in the study will receive the best standard treatment available at the treating institution which their physician determines to be most appropriate for their care. Two out of three patients will also, in addition, receive 177Lu-PSMA-617 in combination with this best supportive or best standard of care, and one out of three patients will receive the best supportive or best standard of care alone.

Will study patients need to pay out of pocket costs?

Participants in this clinical trial will not be charged for study-specific tests and procedures. The study medication, 177Lu-PSMA-617, will be provided at no charge. Payment of costs for tests and procedures performed as standard of care (tests that would be performed as part of regular medical care) for participants in clinical trials varies by insurance coverage and is the responsibility of the patient.

Are there side effects of the study drugs?

As with any experimental drug, it is not always possible to predict all the potential risks of treatment with it. There are side effects associated with any medicine that a physician may prescribe as part of the best standard of care or best supportive care as well as the investigational drug, 177Lu-PSMA-617. Before any patient elects to participate in a clinical trial, they should speak with their doctor about the potential risks and benefits associated with getting the experimental therapy.