Free randomized clinical trial of gallium-68-PSMA-11 PET indicator

A randomized clinical trial of the 68Ga-PSMA-11 PET indicator for men with a recurrence after radical prostatectomy has just been initiated at the University of California Los Angeles (UCLA).

Eligible patients must have a PSA level of ≥ 0.1 ng/ml after prostatectomy and be considering salvage radiation therapy (SRT). This new trial is actually an expansion (by the addition of a control arm) to the trial they conducted earlier (see this link) In that earlier trial, the investigators found that the PSMA-based PET scan was able to change treatment decisions in about half the men.

Here is the link to the full trial details for the new trial and the relevant contact information.

UCLA normally charges $2,650 for this PET indicator, so this is an opportunity to save some money. If a patient is randomized to the control group, he may still get an Axumin PET scan when his PSA is confirmed above 0.2 ng/ml, which is covered by Medicare and most insurance. The Axumin PET scan only detects cancer in 38% of patients if their PSA is in the range of 0.2 to 1.0 ng/ml, while the 68Ga-PSMA-11 PET scan detects cancer in about 27 to 58 percent of recurrent men whose PSA is between 0.2 and 0.5 ng/ml. UCLA recently completed another clinical trial comparing Axumin to 68Ga-PSMA.

We’ve been told that the NIH trial of another PSMA PET indicator, DCFPyL, has a waiting list of 2 to 3 months, and they are no longer taking patients whose PSA is below 0.5 ng/ml. It is possible to pay for PSMA-based PET scans in Germany and Australia. The newest and perhaps most accurate PSMA-based PET indicator, 18F-PSMA-1007, is in clinical trials in Germany (see this link).

This trial is not open to men who have already had SRT, have known metastases, have had ADT within the last 3 months, or who cannot have radiation for any reason.

Editorial note: This commentary was written by Allen Edel for The “New” Prostate Cancer InfoLink.

One Response

  1. Thank you, thank you, Allen, for bringing this to our attention. And I believe Dr. Almeida also has a very low cost trial with PSMA R2 in Phoenix.

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