laser focal ablation trial, HALO dx, Palm Desert, seeking reviews, feedback from patients

[markolcott]

I am new here.

I wish i had done a better job on the net earlier but happy to have found this site now. I was diagnosed with prostate cancer May 2021. Intermediate, Gleason 3+3, 3+4, PSA up and down between 5.7 and 9. Most recent 6.7. Urologist's is known for his skills with DaVinci, removing the prostate. He recommended radiation treatment for me. In the course of my due diligence, I have met with doctors at UCLA, The Mayo Clinic, a "CyberKnife" group, and other consulting urologists regarding treatments other than radiation modalities. The radiation treatment options all required many months of hormone treatment because of the size of my prostate, 130cc.

I have read numerous studies, independent and advocacy papers, watched industry presentations by various groups on the net, etc./ In the course of this I cam across a group in Palm Desert. I read their material, tracked down some studies, etc. I had consultations with their team. Very Impressive many ways. I am seriously considering going this route and I recommend others check it out. The Group is HALOdx. They have a Houston Office.

In the second half of a 20 year trial, this treatment is not covered by Insurance. However, if it is as good an option as it seems, it would be worth it. The reported results are excellent, compararable to radiation in kiiling the cancer cells with a much much lower rate of the kinds of side effects possible using radiation.

I am reaching out to see if anyone has considered or participated in this trial.

Thank you vey much,

Mark

[Tall_Allen]

The reason insurance does not cover it is because it doesn't work. Job #1 of any prostate cancer treatment for any localized prostate cancer is curing you of your prostate cancer. Focal laser ablation does not do this. In fact, 40% of favorable risk treated men still had cancer in their prostates after paying out of pocket for these expensive treatments.

What is your risk level? Gleason score, PSA and stage? Are you having urinary problems because of your enlarged prostate?

If you have low risk prostate cancer, is there any reason you can't be on active surveillance?

If you are intermediate risk, 120 cc is still possible for SBRT or HDR brachytherapy. ADT will, of course shrink your prostate, a 5ARi medicine will shrink it more slowly, but has fewer side effects.

[markolcott in reply to Tall_Allen]

Thank you very much for taking the time to respond and recommend.

I have met with Cyberknife and with low dose radiation providers, inc Mayo and UCLA. The need to shrink my prostate by means of hormone treatment over many months encouraged me to at least look at other solutions. In regards to Focal Laser Ablation and HALO Dx, I think the lack of insurance coverage may be related to the fact that the treatment is too new to have enough time and patient outcomes to validate its efficacy.

I think that my attraction or interest in it is related to the idea that the adverse attendant outcomes sometimes resulting from the radiation treatments are theoretically reduced. Their findings seem to support this idea. Also, as a percentage, the number of patients who have had a recurrence of cancer seem to be no greater as a percentage than patients who had various forms of radiation therapy. Thing is, the numbers of patients are very low at this point, and I don't know if the data is apples to apples, ages, stages, etc.

It looks good on a blackboard to me. The consultations have been informative. I read a chinese study based on thousands of cases who did not dispute the potential of FLT but concluded that Radiation is still the best option until many more numbers come in.

I have scheduling another MpRI and MRI Biopsy and will send the results to places like the Cleveland Clinic and others for second opinions and recommendations.

I appreciate your input.

Thanks Again.

I still hope to hear from anyone who has been a patient of HALO Dx.

[Tall_Allen in reply to markolcott]

There is a sure way to avert ALL side effects of treatment -- don't get treated. There is no point in undertaking any therapy that doesn't do job #1 - cure the cancer.

You are quite incorrect when you write: "Also, as a percentage, the number of patients who have had a recurrence of cancer seem to be no greater as a percentage than patients who had various forms of radiation therapy. " The biochemical recurrence rate for, say, SBRT for favorable intermediate risk patients is 3%, not 40%.

John Fuller's 10 year FLA trial is the longest-running one. As you see, the results are pretty poor.

[Tall_Allen in reply to Tall_Allen]

In case it's not clear, John Feller is the Chief Medical Officer of HALO Dx, and the 10-yr trial of FLA with the poor results (41% recurrence) are his.

auajournals.org/doi/pdf/10....

[esperandrich]

I say go back to UCLA or Mayo Clinic and get their opinions. They are NCI cancer centers. I live in the Palm Desert area and I went to UC San Diego and was treated there. It is also an NCI cancer center. I am gleason 8 so a bit different than you but I am very happy with UC San Diego.

Might want to get an opinion from UC San Diego too.

I got five different opinions from City of Hope, Loma Linda, and UC San Diego before deciding on proton, LDR brachy, and at least one year of ADT (Lupron) but everybody is different.

Two urologists(surgeons) and three radiation oncologists.

Also, had the biopsy checked out two times including Johns Hopkins.

Agree with Tall Allen on that suggested treatment you are thinking about is not the way to go.

[Bigm789]

Approved Category III Code: Ultrasound-guided focal laser ablation-prostate tissue0655T: Transperineal focal laser ablation of malignant prostate tissue, including transrectal imaging guidance, with magnetic resonance-fused images or other enhanced ultrasound imaging. (Do not report 0655T in conjunction with 52000, 76376, 76377, 76872, 76940, 76942, or 76998.

Get a Focal Laser Ablation opinion or Tulsa from ,Dr. Eric Walser- UTMB , Houston, TX. Tall Allen , refuses to interview him, hear his side, offer the Malcare community another side , Walser he is a pioneer and innovator. The Divinci community, wont tell you about him. Also Dr. Marks @ UCLA trying to mimic his procedure transrectally and his results but does not do it, the safer route transperineal. The radiation route is available SBRT @ UCLA, probably one of the best but if your tumor size is not huge and G7 grade under 5% you might avoid, the radiation route, determine through Invitae , SF, CA , genetic test, to determine if you do not have a genetic aggressive Profile. Get PSMA pet scan , to feel more confident no mets spread.

The laser ablation requires annual MRI and probably annual or 2 year biopsy. But it may be worth it, 70% + success rates over 5 years does not preclude doing SBRT later if BCR crops up. Substantially less side effects, catheter removed under 4 days and no pain, Tadalafil for 3 months for ED if needed, Semenex , natural supplement post healing, your prostate will shrink 50%, but you will maintain your ejaculate at least 50%. No ED. A strong women will stand by you, it will save your sex life at least 5 yrs. Candel Therapeutics, immunotherapy treatment drug 2409 P3, coming, 2023, could be 1,2 punch, the procedure has very little toxicity. SBRT has urinary and bladder, issues, Dry orgasm , no more ejaculate ever and long term blood inflammation in urine from tissue for some. You may get coverage for this procedure many people are now. Its worth a consult.

[markolcott in reply to Bigm789]

Thanks so very much. I will contact Dr. Walser.

[calavo in reply to Bigm789]

Thanks, this is first I've heard of Candel 2409. The current Phase III study seems to test it as a less toxic replacement to ADT in combination with RT.

Monotherapy is mentioned in press release but not discussed.

"Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings."

globenewswire.com/news-rele...

[calavo in reply to Bigm789]

Interesting information from Candel Therapeutics regarding Candel 2409. A clinical trial is underway for AS patients:

Randomized controlled phase 2 clinical trial of CAN-2409 followed by valacyclovir for patients undergoing active surveillance for localized prostate cancer: the ULYSSES trial (PrTK04)

More than 50% of patients with prostate cancer are diagnosed at early stages of disease with low grade, low volume, asymptomatic disease. Active Surveillance (AS) is an approach to manage patients with regular Prostate-Specific Antigen (PSA) and biopsy-based monitoring of disease status. This approach is aimed at deferring radical treatment, however, within 10 years of diagnosis, between 21 and 38% of men will have developed progressive cancer and require invasive treatments. Oncolytic viral immunotherapy using CAN-2409 may provide these patients with a low-risk local intervention and the opportunity to delay or prevent disease progression without the need for surgery or radiation.

Primary outcome measure: Disease-free survival

We have completed enrolling a 187-patient phase 2 study in localized prostate cancer patients choosing active surveillance – we call this course of action “Proactive Surveillance.”

candeltx.com/patients/

[Alexandr1]

Tall Allen is a true expert and I defer to him in almost all discussions, but believe the suggestion that “focal ablation does not work” needs to be amended by “focal ablation works for some patients, some of the time.” I am one of those, with Tulsa Pro (Alta Klinik, Germany, September 2019) either eliminating my cancer, or setting it back for a matter of years—after which I would gladly undergo the surgery again, to avoid the possible challenges contained within other approaches. I will continue on an Active Surveillance routine, prepared to either do nothing further, or Tulsa Pro again, or other treatment as needed and indicated…

[markolcott in reply to Alexandr1]

Thanks v much! I appreciate both your respect for Tall Allen and also your different perspective on why you chose Tulsa Pro

[Tony666]

Should you prefer surgery to radiation but have been told you are not a good candidate because of the size of your prostate, there are several trials with 6 months Intensive ADT prior to surgery. In addition to helping control the cancer, the intensive ADT can shrink the prostate considerably (maybe by as much as 50%) and make surgery easier.

[markolcott in reply to Tony666]

Thanks Tony, I am told I'm a good candidate for the different types of radiation therapies but must use hormones/ finasteride, for a few months prior.

[j-o-h-n]

Greetings mark, (some questions are redundant - sorry)

Please tell us your bio. Age? Location? When diagnosed? Treatment(s)? Treatment center(s)? Scores Psa/Gleason? Medications? Doctor's name(s)?

All info is voluntary, but it helps us help you and helps us too. When you respond, copy and paste it in your home page for your use and for other members’ reference.

THANK YOU AND KEEP POSTING!!!

Good Luck, Good Health and Good Humor.

j-o-h-n Sunday 01/23/2022 10:48 PM EST

[markolcott in reply to j-o-h-n]

Age: 73, Married, Active. Golf, Hike, Bike (not since diagnosis).

Diagnosed with moderate risk prostate cancer in May 2021.

Needle Biopsy April 26, 2021. Dr Bernard Bhuerk. 2 cores with cancer, Adenocarcinoma, Gleason Score 7 (3+4) Left Base/ 6 (3+3) Right Mid

PTEN Moderate risk Category

PSA has been elevated with wide swings since 2003. Ignorance of how having sex the night before a test can impact PSA scores may have had something to do with these scores.

In 2003 following a 9.7 PSA score and an MRI, had a biopsy that was negative.

PSA from 2004 to 2010, 4.9 to 7.

PSA from 2011 to 2020, 4.9 to 8.7. Most recent 6.7 July 7, 2021.

In late 2020 had a high score 10.15 went back to low 6 in Jan 2021)

The high score led to other tests and MRI

4K Score: 15% Nov 2021, My PSA on that score was 10.15, PSA, free 1.88, 18% risk range

3t MRI Dec 10 2020

FINDINGS: The prostate gland measures approximately 6.6 x 5.7 x 6.6 cm for an estimated volume of 130 cc. There are changes of BPH in the transition zone. No suspicious lesions. The peripheral zone is diffusely heterogeneous. There is a IO x 7 mm focal T2 hypointense lesion in the left posterior medial peripheral zone at the mid gland which is low in signal on ADC but isointense to slightly hyperintense on diffusion and does not demonstrate focal early enhancement. It is considered a PI RADS 3 lesion. No significant capsular bulging. Seminal vesicles are not well distended but are grossly intact. No pelvic lymphadenopathy.

Bladder demonstrates a diffusely thickened wall likely related to chronic outflow obstruction. Visualized bowel is normal in caliber. No significant free fluid in the pelvis. No suspicious osseous abnormality.

IMPRESSION:

Enlarged prostate with BPH. PI RADS 3 lesion in the left peripheral zone at the mid gland.

PIRADSTM v2 Assessment Categories

PIRADS I - Very low (clinically significant cancer is highly unlikely to be present) PIRADS 2 - Low (clinically significant cancer is unlikely to be present)

PIRADS 3 - Intermediate (the presence of clinically significant cancer is equivocal) PIRADS 4 - High (clinically significant cancer is likely to be present)

PIRADS 5 - Very high (clinically significant cancer is highly likely to be present)

April 26, 2021 Biopsy, needle, 12 core samples

2 cores with cancer, Adenocarcinoma, Gleason Score 7 (3+4) Left Base/ 6 (3+3) Right Mid

PTEN Moderate risk Category

Infection followed, urination burn, Subsequent Test June 14th/ PSA 11.2/ PSA Total+ % free test / free 2.27/ % 18%

Followed up in July, PSA 6.7

August Scans body and lower body, no sign of cancer outside prostate.

[j-o-h-n]

Thank you sir for your quick and detailed reply. It would be a good idea to copy and paste your response on you home page for future reference by you and by other members.

Now this just a suggestion but if I were you I would post your bio on a separate request (not here, not now) and ask this one question. "Brothers please help and guide me on what should my approach be in fighting the devil".

Good Luck, Good Health and Good Humor.

j-o-h-n Wednesday 01/26/2022 3:19 PM EST

[Bigm789]

Safety and Feasibility of Soractelite Transperineal Focal Laser Ablation for Prostate Cancer and Short-term Quality of Life Analysis from a Multicenter Pilot Study

[Bigm789]

sciencedirect.com/science/a...

[markolcott in reply to Bigm789]

Thank you very much for the link. At the risk of taking your time without benefit to you, I'd like to share my situation and see if you have more info or opinion you'd like to share. It goes without saying, I would share any of my learnings.

After lots of reading and engagement with others, I learned a few weeks ago, via MassiveBio, that there is a FLT trial now at Mayo Rochester.

I'm inclined to believe that there must be logic and data and the potential for good health outcomes and potential commercial benefits that led Mayo to create their trial.

I recently had a second MRI and subsequent MRI guided biopsy. This was with the intention of scheduling FLT at HaloDX soon.

The recent MRI(March 2022) looked different than the one I had 16 months ago (it was less predictably problematic). Additionally, the recent MRI guided biopsy, which focused on the 2 zones previously diagnosed as having cancer, had the samples designated as benign by the pathologist.

I recognize that the odds are very great that I still have cancer and that somehow, the latest biopsy (which seemed expert, diligent and organized) just got samples in the same zones that were free of cancer.

I have decided to have both sets of slides/blocks sent somewhere and get a second opinion on both. I may try to get second opinions that include a review my MRI's and Slides/Blocks.

Given the original pathology report rated my samples as 3+3, 3+4, I've felt I have time to monitor and seek out all my options. However, my prostate is very very large (140) and I'd like to shrink it without using hormones. If it was not s large, I might consider waiting and having another MRI in 6 months.

There are a number of places that provide second opinions. I've taken a quick look at Johns Hopkins and Stanford Medical group. I plan on choosing someone by next week.

I would appreciate any input and of course would be happy to share my experience over the past year after learning I had prostate cancer.

Cheers

Mark

[calavo in reply to markolcott]

miR Scientific has made commercially available in the last 3 weeks a liquid biopsy test they claim 90 percent accuracy in identifying low, intermediate and high risk prostate cancer. I haven't heard from anyone who has taken it. It costs around 1200 dollars. There are positive reports regarding the test from researchers and Doctors in PCa field.

mirscientific.com/

[calavo in reply to markolcott]

I too follow HALO and found the latest patient testimonial marketing video interesting. The patient says he was a radiation oncologist specializing in prostate cancer and loved his job at an important institution in southern California. My question is why didn't he treat his own cancer with his own treatment? I found his email and wrote him a letter but he didn't respond. So it will remain a mystery for now.

halodx.com/blog/focal-laser...