PSMA-SRT Randomized Phase 3 Trial is now open at UCLA

Every now and again I’m asked to share information on my blog, and this was something that is of personal interest to me given my current situation. It’s from the UCLA Nuclear Medicine department and will likely be of interest to others as well.

They reference a couple of attachments in their email to me, but none were attached.


We have the pleasure to announce the opening of a Randomized Prospective phase 3 trial of PSMA PET/CT based salvage radiation therapy (PSMA-SRT) at UCLA Nuclear Medicine (NCT03582774).

https://clinicaltrials.gov/ct2/show/NCT03582774

This is the first randomized prospective phase 3 trial designed to determine whether PSMA PET/CT can improve outcomes in patients with prostate cancer biochemical recurrence.

PSMA PET/CT will be free of charge for patients (100% sponsored by UCLA Nuclear Medicine).

Patients who are planned for salvage radiation therapy (SRT) for recurrence after primary prostatectomy with PSA ≥ 0.1 ng/ml are candidate.

We will randomize patients to proceed with standard SRT (control arm 1) or undergo a PSMA PET/CT scan prior SRT planning (investigational arm 2).

Patients randomized to control arm 1 will not undergo PSMA PET/CT: SRT will be performed as routinely planned per discretion of the treating radiation oncologist. Any other imaging will be allowed for SRT planning if done per routine care.

Patients assigned to arm 2 will be scheduled to undergo a PSMA PET/CT scan at UCLA Nuclear Medicine (free of charge) prior to radiation therapy planning. DICOM images and reports of PSMA PET/CT scans will be delivered to the treating radiation oncologist.

The radiation oncologist may change the radiation plan depending on the findings of the PSMA PET/CT scan. That is, the treating radiation oncologist may use whatever dose, fractionation, and target volumes they choose, and may use concurrent ADT or not, at their discretion (please see the attached document for the radiation therapy management specifications).

The primary endpoint of the trial is the success rate of SRT measured as 5-year biochemical progression-free survival after initiation of SRT.

Patients will be followed by the UCLA Nuclear medicine research team for up to 5 years after initiation of SRT (phone/fax/secure emails with the treating radiation oncologist team and/or with the patient) every 3-6 months (routine PSA and imaging).

To enroll a patient:

  • All subjects must sign the UCLA IRB approved informed consent form (ICF, attached) before enrollment and randomization.
  • For UCLA patients, this will be done after a consultation with the UCLA Nuclear Medicine Team or the UCLA Radiation Oncology Team.
  • For all other patients outside of UCLA, this will be done after a phone consultation with the UCLA nuclear medicine research team. Signed ICF will then be obtained by fax or email.
  • The randomization number and assigned arm will be communicated by phone or email to treating physicians and patients one day after the enrollment.
  • Patients randomized to control arm 1 will not need to come at UCLA and will receive SRT per routine care at the treating radiation oncologist institution.

This trial represents a good opportunity for all the patients who cannot afford the out-of-pocket costs of a research PSMA PET/CT (at UCLA: around $2700).

Please try to spread the word as much as you can around you.

In advance I thank you very much for your collaboration.

Please don’t hesitate to contact us if you have any question:

Jeaninne Gartmann, Study Coordinator: JGartmann@mednet.ucla.edu
Jeremie Calais, Principal Investigator: JCalais@mednet.ucla.edu
Nicholas Nickols, Co-Principal Investigator: NNickols@mednet.ucla.edu

Best regards

Jeremie Calais MD MSc
Assistant Professor
UCLA Nuclear Medicine

Medical Xpress: Research finds ‘Achilles heel’ for aggressive prostate cancer

Here’s an interesting article that shows promise in the treatment of advanced prostate cancer that popped up in one of my news feeds.

Medical Xpress: Research finds ‘Achilles heel’ for aggressive prostate cancer.

 

NEJM: Quality of Life and Satisfaction with Outcome among Prostate-Cancer Survivors

As you could tell from my last post, I’ve really been focusing on the impact of any salvage treatment options on the quality of life (QOL), both during treatment and longer-term.

I stumbled across this 2008 study, Quality of Life and Satisfaction with Outcome among Prostate Cancer Survivors, published in the New England Journal of Medicine, but it shows the QOL impact after first-line treatment only.

Tables 2 and 4 in the paper are precisely how this data-driven, numbers geek would love to see the information on salvage therapies presented. Obviously, the categories measured may have to be modified and expanded to include the known side effects of the salvage treatments.

If Dr. Martin G. Sanda, et al., stumble across this post and care to build upon their previous excellent work, please feel free to do so! In the interim, I’ll keep searching.

 

PCF Article: New Biomarker Predicts Metastatic Prostate Cancers

Here’s an interesting article from the Prostate Cancer Foundation about a potentially exciting development in the ability to determine which prostate cancer tumors are more likely to metastasize.

New Biomarker Predicts Metastatic Prostate Cancers

Article: Radical revision of treatment for prostate cancer could extend life

Here is a very interesting and perhaps controversial article about shifting how we approach the treatment of prostate cancer:

Radical revision of treatment for prostate cancer could extend life

Article: Defining biochemical recurrence after radical prostatectomy and timing of early salvage radiotherapy

I came across this interesting abstract of a study in Germany that suggests defining biochemical recurrence after radical prostatectomy at the 0.1 ng/ml level instead of the widely accepted 0.2 ng/ml.

The vast majority of patients with PSA ≥0.1 ng/ml after RP will progress to PSA ≥0.2 ng/ml. Additionally, early administration of SRT at post-RP PSA level <0.2 ng/ml might improve freedom from progression. Consequently, we suggest a PSA threshold of 0.1 ng/ml to define biochemical recurrence after RP.

You can read the full abstract here.

Of course, with my latest PSA at 0.08 ng/ml, that’s far closer to 0.1 than 0.2. I know it’s just one study, so I’m not going to get worked up over it for now. Something else to talk with the doctor about in September (gotta keep ’em on their toes!).

Article on PSA and Aggressiveness of Prostate Cancer

An excellent article about PSA and being able to determine the aggressiveness of prostate cancer.

https://www.statnews.com/2017/05/04/prostate-cancer-research-psa/

This Test Can Tell If Your Prostate Cancer Will Come Back

I came across this interesting article late tonight talking about how, if your post-treatment PSA nadir after RT or ADT is greater than 0.5 ng/ml, you’re more likely to have the prostate cancer return.

I’m going to re-read this with a fresh set of eyes tomorrow to better understand the study and its details.

http://nbcnews.to/2jIKECd

Immediate radiation when PSA levels spike after prostate cancer surgery helps reduce risk of recurrence

It’s funny that just 24 hours after having a discussion with my doctor about this very topic, this article appears on one of my social media news feeds.

My medical team seems reluctant to embrace some of the newer studies like this, sticking to the 0.2 ng/ml definition of biochemical recurrence that’s been the standard for years and years. That makes me wonder how long it takes before the medical community accepts the newer data and studies, and shifts treatment regimens to the new guidance.

Don’t get me wrong. I’m not ready to hop on a table and get radiated just because of this paper (or the two others earlier in the year along the same lines), but it is something that I’ll be keeping an eye on going forward.

More than anything at this point, I’m just sharing an observation of how the medical research community and the medical community at large can sometimes be at odds with each other, knowing how conflicting and confusing it can be from a patient’s perspective. It just reinforces my belief that you have to do your own research, be your own advocate, and make decisions that YOU are comfortable with based on what you’ve learned.

—Dan

For men who have had prostate cancer surgery, radiation therapy at the first sign of a rising PSA level can reduce the chances of the cancer recurring.

Source: Immediate radiation when PSA levels spike after prostate cancer surgery helps reduce risk of recurrence

BBC News: Prostate cancer laser treatment ‘truly transformative’

I came across this article on BBC and found it to be an interesting development in yet another potential treatment option. It will be interesting to see how future trials pan out.

Prostate cancer laser treatment ‘truly transformative’ – http://www.bbc.co.uk/news/health-38304076