Is anyone in the in the Phase 3 trial going on at UCSF & Stanford that started in 2018 that will conclude August 2022. Any updates as to how it’s going
Clinical trial at UCSF, 177Lu-PSMA-617.
It’s for anyone with castration-Resistant PC
and Mets to distant site a participant??
Link to the trial info:
clinicaltrials.gov/ct2/show...
Inclusion Criteria:
The subject is able and willing to comply with study procedures and provide signed and dated informed consent
Histologically confirmed prostate adenocarcinoma. De novo small cell neuroendocrine prostate cancer will not be allowed due to putative lower PSMA expression in this tumor subtype. Treatment-emergent small cell neuroendocrine prostate cancer detected in metastatic tumor biopsy is not an exclusion
A minimum of three PSMA-avid lesions on baseline 68Ga-PSMA-11 PET, with positive lesions defined as those with maximum standardized uptake value (SUVmax) values greater than liver.
Progressive metastatic castration-resistant prostate cancer by Prostate Cancer Working Group (PCWG)3 criteria at the time of study entry
Castrate level of serum testosterone at study entry (< 50 ng/dL). Patients without prior bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study
Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide
Absolute neutrophil count > 1.5 x 10^9/L
Hemoglobin > 9.0 g/dL
Platelet count > 100,000/microliter
Serum creatinine =< 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (GFR) > 50 ml/min by Cockcroft-Gault or 24 hour urine collection
Total bilirubin =< 1.5 x ULN. In patients with known or suspected Gilbert's disease, direct bilirubin =< ULN
Aspartate aminotransferase and alanine aminotransferase =< 2.5 x ULN (<= 5 x ULN in patients with liver metastases)
No other systemic anti-cancer therapies administered other than LHRH analogue within 14 days, or 5 half-lives, whichever is shorter, prior to initiation of study treatment. Adverse events related to prior anti-cancer treatment other than LHRH analog treatment must have recovered to Grade <= 1 with the exception of any grade alopecia and grade <= 2 neuropathy.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients must use appropriate methods of contraception during study treatment and for at least 60 days after last study treatment
Patients who are sexually active should consider their female partner to be of childbearing potential if she has experienced menarche and is not postmenopausal (defined as amenorrhea > 24 consecutive months) or has not undergone successful surgical sterilization. Even women who use contraceptive hormones (oral, implanted, or injected), an intrauterine device, or barrier methods (diaphragms, condoms, spermicide) should be considered to be of childbearing potential
Patients who have undergone vasectomy themselves should also be considered to be of childbearing potential
Acceptable methods of contraception include continuous total abstinence, or double-barrier method of birth control (e.g. condoms used with spermicide, or condoms used with oral contraceptives). Periodic abstinence and withdrawal are not acceptable methods of contraception
Patients must provide consent to comply to recommended radioprotection precautions during study
Patients willing to undergo tumor biopsy and have at least one lesion safely accessible to tumor biopsy. Bone or soft tissue lesion is allowed
Measurable disease by RECIST 1.1 criteria
San Francisco, California, United States, 94115
Contact: Patricia Li 415-476-5975 GUTrials@ucsf.edu
Contact 877-827-3222 cancertrials@ucsf.edu
Principal Investigator: Rahul R. Aggarwal, MD
So looking at those requirements. It appears any lesion must have an SUV max greater than the liver. Does that mean uptake is not considered metastatic unless it exceeds the uptake of the liver?
Yes, to reduce false positive they may use the SUV of the liver or the bone marrow as a reference.
UCSF has two open Phase I trials. The only Phase 3 trial (VISION) is no longer recruiting. They've published results and we are awaiting FDA approval.
I have a Zoom appointment with Dr. Aggarwal coming up. In looking at the criteria it appears I qualify. Last PSMA PET scan showed one lesion in right seminal vesicle and a half dozen retroperitoneal lymph nodes. If I am accepted I will post my progress.
Hi xpbdb, may I ask - do you feel comfortable with this criteria: “Patients willing to undergo tumor biopsy and have at least one lesion safely accessible to tumor biopsy. ” ...? Do you think this will require surgery, or can a needle biopsy be done in some cases? Obviously a newbie question, sorry.
Have your lesions shown radiographic progression while on ADT? My understanding from the PCWG3 criteria is that rising PSA alone is not sufficient, as per this transcript:
urotoday.com/video-lectures...
I could be misunderstanding this. I ask b/c I’m also very interested in this trial at the point I become CR.
Regardless, good luck - I hope you are accepted.
I am going to see my urologist today. I am going to ask him if the lesion in my seminal vesicle can be surgically removed. I already have had high dose brachytherapy to that area and cannot have more radiation. I had a pelvic lymph node ultrasound guided biopsy a few years ago (positive) and did not feel a thing. On the other hand, I had 2 prostate biopsies 11 years ago when I was diagnosed and those are no picnic, To answer your question, in my opinion a core biopsy is the way to go. Yes my disease progressed after 18 months of ADT. First Lupron and then Orgovyx with Xtandi. I changed from Xtandi to Zytiga and prednisone 3 weeks ago. Too soon to tell if it has slowed the disease progression. 3 years ago, my PSMA PET scan showed 3 lesions. The scan I had 2 months ago showed 7 or 8, so yes radiographically there is progression. The Lu-177 PSMA treatment utilizes beta radiation, which only travels millimeters in human tissue, so previous radiotherapy is not an issue, but you probably know that already.
I also have Zoom appointment with Dr. AggarwalOct 25 Th after next PSMA PET ON Oct 18Th I’ve had RP ,Radiation and ADT and a trial with Dr Aggarwal. Also was in PSMA trial two years ago at UCSF which was clear Current PSA doubling rate every 2 months. I was just trying figure out if
Lu-177 had progressed since I talked about it in 2016 with radiation oncologist at that time at that time. His exact words to me was at that time it was not ready for prime time yeah they still haven’t figured out dosages and timelines. Was hoping to see results it was showing promise. I’ll be looking forward to your results being posted if you are included in trial. Good luck and thanks for responding
Greetings Bub,
Please tell us your bio. Age? Location? When diagnosed? Treatment(s)? Treatment center(s)? Scores Psa/Gleason? Medications? Doctor's name(s)?
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THANK YOU AND KEEP POSTING!!!
Good Luck, Good Health and Good Humor.
j-o-h-n Monday 09/06/2021 10:18 PM DST
Thank you sir........ now we can delete your $750.00 fine. You're now at a zero balance (but watch your step!!!).
Good Luck, Good Health and Good Humor.
j-o-h-n Wednesday 09/15/2021 7:12 PM DST
No, but I’m keen to see and hear any results. I’ve been working with Stanford (and UCSF a for second opinions). and am BCR but am still hormone sensitive.
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