New Trial of Lu-177-PSMA-617 to begin April 30, 2021.

[Tall_Allen]

Novartis has announced a new multi-institutional randomized clinical trial of Lu-177-PSMA-617 that is scheduled to begin April 30, 2021. This one will focus on men who have not been previously treated with chemo (e.g., Taxotere, Jevtana, carboplatin, etc.), an immunotherapy, or any other PSMA-targeted therapy. Xofigo is allowed if it was used more than 6 months ago. Treatment with and resistance to at least one advanced hormonal therapy is required.

Participants must have progressive metastatic castration-resistant PC. There must be at least 1 metastasis identified in the last month with bone scan/CT/MRI.

Although it is randomized 1:1, patients in the control group (who will receive an untried advanced hormonal) will be allowed to receive the Lu-177-PSMA-617 after there has been radiographic progression.

They haven't yet signed up the institutions that will participate, but I imagine it will include many of the same institutions as the VISION trial.

(edit: I added a link to the other PSMA-targeted radiotherapy trials in the US)

prostatecancer.news/2020/08...

[StayingOptimistic]

Thanks TA for posting and your research. Although I am not qualified at this time but it’s always very nice to know what’s available to patients.

[45yrsDenmark]

Thanks TA... I also wonder what is new compared to the VISION trial...

[Tall_Allen in reply to 45yrsDenmark]

In the VISION trial, one had to have had chemotherapy. This is only for chemo-naive men.

[ronton2 in reply to Tall_Allen]

I have never participated in a clinical trial. Do I contact my MO at SCCA to get information about the Novartis opening for LU 177 PSMA 617. How do I make contact if not through my MO

[Tall_Allen in reply to ronton2]

When they enroll institutions to conduct the trial, they will publish the people to contact and their contact info. At that point, you can call or email directly. They'll tell you how to enroll. They will undoubtedly require your medical records from your doctor.

[Runner4000]

Do you feel that this trial might be a better option than chemo for one who's PSA has begun to rise after being on Lupron but not a second-line ADT drug?

[Tall_Allen in reply to Runner4000]

You are ineligible. You have to have taken and failed one second-line ADT drug.

[Runner4000 in reply to Tall_Allen]

One additional question. Do you feel it might be useful to start chemo when PSA is at .5 or a bit over?

[Tall_Allen in reply to Runner4000]

Where are your metastases?

[Runner4000]

As of last choline PET scan and PSMA scan: Nothing in bones; apparent activity within the mediastinal lymph nodes (a biopsy about a year or so confirmed PC in one node, but not in another); some activity in retroperitoneal lymph nodes in abdomen and pelvis. PSA at .2 on 11/30/2020 and consistently increasing at a rate of 14%/month. I think it will be around .5 by early June, 2021, at which time I am to return to Mayo Rochester for scans and tests. No pain and tolerating Lupron reasonably well. Regular exercise.

[Tall_Allen in reply to Runner4000]

Chemo or a second-line hormonal might be a good idea if the new scan shows progression.

[Runner4000 in reply to Tall_Allen]

Thank you. As you know, Mayo seems now to suggest taxotere first, then Zytiga, then Jevtana, then Xtandi. I'm assuming that's what my MO will suggest, starting right away. We'll see. Thanks for all of your thoughtful inputs on this site. And Happy New Year.

[Tall_Allen in reply to Runner4000]

I agree with that order for men who are metastatic and castration-resistant, and I think there is a good logistical reason to do chemo first.

prostatecancer.news/2019/12...

prostatecancer.news/2019/02...

[Runner4000 in reply to Tall_Allen]

My current thinking is to try taxotere first, since based on STAMPEDE, etc. and extensive real-world experience that seems like a "tried and true approach". Then, if I survive that, after a PSMA scan, I think I should consider Lu177, even if that means trips to Germany or Australia. I think that approach might achieve better results than Xtandi or Jevtana as next steps. Admittedly, however, I don't have either the expertise or data to base that view upon. Perhaps you do. Maybe the VISION trial will add some useful information, although it involves individuals with chemo and second-line ADT. Also, maybe there will be other Lu177 trials by the time I finish chemo.

Lymph node involvement is not considered "high burden" cancer is it? I see that September 2019 STAMPEDE data showed much better overall survival results for "low burden" cancer than "high burden" cancer.

This is my final imposition on your time....at least for some months!

[timotur in reply to Runner4000]

"Low-burden" was <5 mets in the axis of the midline of the body (e.g. spine). "High-burden" was >5 distal mets so many cm's off the midline, (e.g. on the ribs). Congrats on a good 15-yr run!

[Tall_Allen in reply to Runner4000]

No imposition at all. I know it is a tough decision, and there is no clear path right now.

This may only add to the uncertainty: There was a small clinical trial done comparing Lu177PSMA to Jevtana as a third treatment after Taxotere and either Zytiga or Xtandi.

prostatecancer.news/2020/05...

All the other radiopharmaceutical (they aren't all using Lu-177) trials in the US require Taxotere and either Zytiga or Xtandi:

prostatecancer.news/2020/08...

Your mediastinal lymph node is stage M1a. STAMPEDE used the following definition:

"high-burden patients had either four or more bone metastases including one or more outside the vertebral body or pelvis, or any visceral metastases, or both. All other patients metastatic at baseline were categorised as having low metastatic burden according to this definition."

annalsofoncology.org/articl...

So if you had no bone mets (stage M1b) or visceral metastases (stage M1c), you are "low metastatic burden." They detected metastases with a bone scan/CT (not a PET scan), and their analysis was only done on newly diagnosed patients (not recurrent).

"I see that September 2019 STAMPEDE data showed much better overall survival results for "low burden" cancer than "high burden" cancer."

Patients with fewer detected metastases always survive longer than patients with more metastases (in the same places). But STAMPEDE showed that the improvement in survival by using docetaxel was the same regardless of the metastatic burden.

[Runner4000 in reply to Tall_Allen]

That is all very, very helpful. Thank you!

[Hidden]

How do I get on the list TA

[Tall_Allen in reply to Hidden]

When they announce which institutions will be participating in April, they will provide contact info.

[Hidden]

thanks

[pilot52]

Great news TA I just finished my 3rd trip to India....save some travel time...albeit out of 30 patients treated all are doing well except one...so good stuff for being chemo naive.....

[Tall_Allen in reply to pilot52]

I have a new friend who I'm encouraging to follow your lead. Thanks for the update.

[GeorgeGlass in reply to pilot52]

Did you see anyone doing the study who is castration sensitive and only done ADT so far? I'm wondering if LU-177 is advised before 2nd line drugs like xtandi or erleada or is it just recommended for after use and failure on those 2nd line drugs?

[pilot52 in reply to GeorgeGlass]

You need to look at Tagawa at Weill Cornell . If you are PSMA avid and negative on standard scanning they have a trial...2 to 1 get one dose of Lu-177. Being chemo naive seems to offer a better outcome...Blue Skies.

[Tall_Allen in reply to pilot52]

That's because earlier treatment usually has better outcomes than later treatment (not because chemo renders it less effective)

[pilot52 in reply to Tall_Allen]

I have spoken with a couple of Nuclear Medicine Specialist. They say that the science is still out either way on Lu-177 before chemo is only because it is done earlier..Sen is going to forward some papers to me..I will send them to you .. Blue Skies

[Tall_Allen in reply to pilot52]

Thanks.

[GeorgeGlass in reply to pilot52]

OK, thanks Pilot, I'll look into it. Maybe I'll be eligible.

[GeorgeGlass in reply to pilot52]

also, how much does it cost for each session in India?

[pilot52 in reply to GeorgeGlass]

I had 3 sessions. They use a higher dose if you are chemo naive . The hospital and all scans and infusion is around 7500 X3 then you have travel and hotel ect.

[Charles4212 in reply to pilot52]

What was the cost of the India treatment?

[Tall_Allen]

The first trial on the table uses adjuvant Zytiga, Xtandi or Erleada. It is scheduled to begin recruiting May 3.

[slpdvmmd]

I believe it is randomized against apalutamide but the question in my mind is why randomize. Plenty of historical data on lutamide outcome. Also wide worldwide experince with Lutetium at this point. Seems like US is just recreating the wheel.

[Tall_Allen in reply to slpdvmmd]

The only way to determine if there is a real benefit is to randomize among patients currently recruited. Different patient populations will have different results. It is randomized for patients to receive another advanced hormonal therapy (one they haven't yet had). There are actually no other completed randomized trials anywhere in the world for Lu-177-PSMA-617 other than the VISION trial and the Australian trial of Lu-177-PSMA-617 vs Jevtana.