A research team at the University of California, Los Angeles (UCLA) is seeking participants for a randomized, Phase III, clinical trial of the utility of 68Ga-PSMA-11 PET/CT molecular imaging for planning of salvage radiotherapy after first-line treatment for localized prostate cancer.
Fuller details about this trial are available here on the ClinicalTrials.gov web site, but here’s the basic scoop.
The trial is exclusively open to men with prostate cancer who are candidates for and/or scheduled to have salvage radiation therapy (SRT) after a radical prostatectomy and whose PSA level has risen from a nadir level to ≥ 0.1 ng/ml (or whose PSA never dropped to < 0.1 ng/ml post-surgery).
The patients will be randomly assigned to one or other of two arms:
- About 95 patients will be given a free 68Ga-PSMA-11 PET/CT scan at UCLA (the experimental arm)
- Another 95 or so patients will just be followed but will not receive a 68Ga-PSMA-11 PET/CT scan (the control arm)
Patients can have any other forms of standard of care imaging in either arm of the study (Axumin PET/CT scans included).
The patients who are assigned to the control arm
- Will never have to come to UCLA
- Will simply be followed over time by the research team in association with their local radiation oncologist, wherever it is that they have their SRT
The patients who are assigned to the experimental arm
- Will be asked to come to the UCLA nuclear medicine division only to get the free 68Ga-PSMA-11 PET/CT scan
- Will not need to see a radiation oncologist at UCLA
- Will be given SRT at the discretion of their own, local radiation oncologist at his or her institution (but with the benefit of the PSMA scan results up front)
What do you need to do to find out more?
- Just make one phone call to the study coordinators: either Jeannine Gartmann (Tel: 310 206 0596; e-mail: JGartmann@mednet.ucla.edu) or Kiara Booker (Tel: 310 206 7372; e-mail: KMBooker@mednet.ucla.edu)
- Individual patients are consented before randomization remotely by phone and will need to send us the signed, consent form by e-mail or fax.
- The research team will work with your local doctor who does your SRT for 5 years post-treatment.
So yes, if you are due to have salvage radiation therapy after a radical prostatectomy, you can get a free 68Ga-PSMA-11 PET/CT scan. The catch is that you have to participate in this clinical trial — and then you have to get lucky and be among the 50% of the patients who are randomized to having a scan.
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: CT, free, gallium-68, PET, PSMA-11, radiation, salvage, scan, SRT, therapy |
THE "NEW" PROSTATE CANCER INFOLINK 
In the Los Angeles area, they are competing for patients. City of Hope and Tower Urology are offering the DCFPyL PET/CT without randomization. I don’t know what, if any, the cost is.
Patients who don’t want to be randomized can also buy the 68Ga-PSMA-11 scan at UCLA for $2,650.
You get a 50% chance for gallium-68 PET/CT. It is not FDA approved. What will you gain? You will get a top restaging of the site of the recurrence. Will you gain from the information? Perhaps, but your doctor has to be aware with what to do to make most benefit for you for the information. So your doctor should be very good on developments in prostate cancer.
The downside is you are offered only a 50% chance of the free gallium-68 scan. That does not guarantee that that option is optimal, just that the option is standard care in USA. So if you feel you need a gallium-68 scan anyway, you have to pay to be sure to get it. And if you choose to pay for the gallium scan, you have to be sure that the physician responsible for your care has insight into using the information to the best of cutting edge treatment of today.
Still confused? Of course. Treatment of prostate cancer is advancing and many trials are helping patients to get more and more treatment early in the course of the disease. But be sure, we have many sources of information, so standard care of yesterday will soon be updated so patients of today have a better life than patients of the past. Best advice for the confused — don’t stop asking for information. Many persons are available for giving updates. Just keep asking.
Let’s be very clear. This is actually a very good deal for (say) a man on Medicare who is probably going to get high quality SRT somewhere in the Los Angeles area or nearby but who doesn’t have a spare $2,650 in ready money (which is true for most Americans).
It is also my reasonable assumption that the results of the gallium-68 PET/CT scan that will be done at UCLA are going to be sent to the treating radiation oncologist with some very specific guidance as to how to use this information in the management of the specific patient. It would be pretty pointless to send the results of the gallium-68 scan out without such specific guidance to someone who may never have seen one before in his or her life!
I just heard back from Progenics about the trial of DCFPyL. They wrote:
“This research study is sponsored and funded by Progenics. The study drug will be provided by Progenics at no cost to you. No payment will be made to you for taking part in this research study. As with any medical care you might receive, you and/or your insurance company will be responsible for the payment of any doctor’s visits, procedures including surgery or prostate cancer treatments that would be part of your routine cancer care.
“There will be no cost to you for the procedures and tests that are being done solely for this research study and would not normally be performed as part of your standard care for prostate cancer. You may also be reimbursed for any reasonable and pre-approved travel costs incurred as a result of your participation in the research study. This will be reimbursed to your study center in order to protect your confidentiality upon receipt of invoice and supporting documentation.”
There are 15 sites — only two have begun recruitment so far.