177Lu-PSMA-R2 / Novartis - LARVOL DELTA

NeoPSMA: Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC (clinicaltrials.gov) - P1/2 | N=228 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Initiation date: Jun 2025 ➔ Jun 2026

Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PROter: 177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=27 | Terminated | Sponsor: Advanced Accelerator Applications | Phase classification: P1/2 ➔ P1

Phase classification • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

NeoPSMA: Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC (clinicaltrials.gov) - P1/2 | N=228 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

NCCN Clinical Practice Guidelines in Prostate Cancer 177-Lutetium PSMA (LuPSMA) Radioligand Therapy - Christopher Wallis and Zachary Klaassen (Urotoday) - "...Zachary Klaassen discuss the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology, specifically focusing on the utilization of Lutetium PSMA in metastatic castration-resistant prostate cancer (mCRPC) patients."

Video

PROter: 177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=27 | Terminated | Sponsor: Advanced Accelerator Applications | Trial completion date: May 2026 ➔ Jun 2022 | Active, not recruiting ➔ Terminated; Recruitment for PROter A206T-G01-001 (NCT03490838) was halted in Phase I by sponsor decision. Phase II expansion portion of the study was never initiated.

Trial completion date • Trial termination • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Choudhury Discusses Sequencing of Therapy in Metastatic Castration-Resistant Prostate Cancer (Targeted Oncology) - "During a Targeted Oncology case-based roundtable event, Atish D. Choudhury, MD, PhD, discussed the CARD trial of cabazitaxel and the VISION trial of lutetium-177 for patients with metastatic castration-resistant prostate cancer."

Media quote

Long Term Use of Lutetium-177-PSMA Therapy for Men With Metastatic Castration-Resistant Prostate Cancer, Journal Club – Christopher Wallis & Zachary Klaassen (Urotoday) - "Zachary Klaassen...In conclusion, this study reported an 18-month overall survival rate of 64% among patients with mCRPC undergoing Lu-PSMA. Serum PSMA responses from baseline after treatment cycle two was an indicator of response and overall survival. Other parameters, which we discussed, including PSA baseline less than 20, SUV max more than 15, and certain metastatic sites, including lymph node only or bone and lymph node metastases were suggestive of improved overall survival. And finally moving forward, this information will be utilized in practice to further improve the evidence basis for Lu-PSMA therapy."

Video

VISION trial - Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer (APCCC 2021) - No abstract available.

PROter: 177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=27; Active, not recruiting; Sponsor: Advanced Accelerator Applications; Recruiting ➔ Active, not recruiting; N=96 ➔ 27; Trial completion date: Dec 2022 ➔ May 2026; Trial primary completion date: Dec 2022 ➔ Jul 2022

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Lutetium 177 PSMA - Problems with the Vision Trial (YouTube) - https://www.youtube.com/watch?v=pAsPzPt2avc

Video

Targeted Radioligand Therapy for PSMA+, Metastatic Castration-Resistant Prostate Cancer (PracticeUpdate) - "Dr. Sartor: We've had the opportunity to view some groundbreaking, game-changing data, and that's for the VISION trial. We had a prospective randomized trial in extremely difficult-to-treat patients. All these patients had metastatic castrate-resistant prostate cancer. All the patients had failed, not only ADT but also one of the novel hormones, like abiraterone or enzalutamide. And they had progressed despite a taxane therapy, typically docetaxel."

Interview • Video

PROter: 177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=96; Recruiting; Sponsor: Advanced Accelerator Applications; Trial completion date: Jun 2022 ➔ Dec 2022; Trial primary completion date: Jun 2022 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CYP17A1

Radiopharmaceuticals in Prostate Cancer Episode 2 (COR2ED) - "Dr. Tanya Dorff...discuss the latest developments in the field of radiopharmaceuticals and their use in Prostate Cancer....This second episode focuses on PSMA-targeted radiopharmaceuticals and how PSMA can be a target for imaging as well as for therapies. Efficacy and safety data from the phase 2 TheraP study are discussed which investigated lutetium-PSMA versus cabazitaxel in patients with mCRPC who had progressed on docetaxel. The experts also discuss the ongoing VISION trial and what the results may mean for clinical practice as well as other ongoing trials looking at lutetium-PSMA in combination with other prostate cancer therapies such as PARP inhibitors, immunotherapies, hormonal therapies and chemotherapy."

Audio

PSMA-directed Therapy - Scott Tagawa and Michael Morris (Urotoday) - "Scott Tagawa...Thank you very much for the invitation to talk about one of my favorite topics which is PSMA-targeted radionuclide therapy. I'm going to give a little bit of background about what is PSMA-TRT. I have a quick comment about efficacy but really focused the talk on once someone's been treated, what to expect....The basis for the therapy is really radiation, and the data that we have is really from external beam, but it basically shows that every organ has a certain dose limit....Probably both comment. I don't know that anyone knows the answer. The dogma has been that worsening disease, so higher grade, higher stage, more AR-targeted therapies, there's more PSMA until [inaudible] and multiple others neither AR nor PSMA."

Video

Radionuclide Targeted Treatment in Progressing Metastatic Prostate Cancer - Michael Hofman (Urotoday) - "Neal Shore: I wanted to delve a little bit into this discordant issue of FDG PET versus PSMA PET as you know and I want to also echo Alicia's comment about the VISION study. Boy, patients just were so enthusiastic about enrolling in that study and it accrued so quickly in the US and we knew that sites were so competitive because we had a pent up demand. Patients were really in need of another line of therapy."

Video

Robert Dreicer, MD, provides results presented concerning PSMA-linked 177Lutethium regarding mCRPC (YouTube) - "Dr. Dreicer...provides results presented concerning PSMA-linked 177Lutethium in the treatment of refractory metastatic CRPC and how will its development proceed."

P2 data • Video

"First preclincal results of 177Lu-PSMA-R2 (@adacap_news) show strong tumour-specific uptake and significant tumour volume reduction in mice inoculated with PSMA-positive PC3-PIP cells #EANM19" (@Cortellis)

Preclinical

PROter: 177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=96; Recruiting; Sponsor: Advanced Accelerator Applications; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open