Neoadjuvant 177Lu-PSMA-I&amp;T Radionuclide Treatment in Patients with High-risk Prostate Cancer Before Radical Prostatectomy: A Single-arm Phase 1 Trial

Golan, Shay; Frumer, Michael; Zohar, Yarden; Rosenbaum, Eli; Yakimov, Maxim; Kedar, Daniel; Margel, David; Baniel, Jack; Steinmetz, A.; Groshar, David; Domachevsky, Liran; Bernstine, Hanna

doi:10.1016/j.euo.2022.09.002

Cited by 23 publications

(13 citation statements)

References 34 publications

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“…A phase I trial demonstrated safety of two or three doses of 177 Lu-PSMA-617 prior to RARP and lymph node dissection for high-risk localized disease. 83 None of the 14 patients treated with 177 Lu-PSMA-617 demonstrated grade ⩾3 AEs during treatment and the postoperative and continence recoveries were similar to RARP alone. 83 LuTectomy (NCT04430192) is an ongoing phase II non-randomized trial of 20 patients with high-risk localized prostate cancer, to assess the radiation-absorbed dose in the prostate and lymph nodes after either one or two cycles of 177 Lu-PSMA-617 prior to prostatectomy.…”

Section: Rnt Studies In Combination With Surgerymentioning

confidence: 86%

“…83 None of the 14 patients treated with 177 Lu-PSMA-617 demonstrated grade ⩾3 AEs during treatment and the postoperative and continence recoveries were similar to RARP alone. 83 LuTectomy (NCT04430192) is an ongoing phase II non-randomized trial of 20 patients with high-risk localized prostate cancer, to assess the radiation-absorbed dose in the prostate and lymph nodes after either one or two cycles of 177 Lu-PSMA-617 prior to prostatectomy. 84 Preliminary results reported 177 Lu-PSMA-617 was safe prior to surgery and well-tolerated with no grade 2-5 AEs and no Clavien-Dindo grade 3-5 surgical complications.…”

Section: Rnt Studies In Combination With Surgerymentioning

confidence: 86%

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Novel radionuclide therapy combinations in prostate cancer

et al. 2023

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Prostate cancer remains the commonest cancer diagnosed in males and a leading cause of cancer-related death. Men with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on chemotherapy and androgen receptor pathway inhibitors (ARPI) have limited treatment options, significant morbidity, and poor outcomes. Prostate-specific membrane antigen (PSMA)-directed radionuclide therapy (RNT) is emerging as an efficacious and well-tolerated therapy; however, disease progression is universal. Several ongoing RNT trials focus on combination strategies to improve efficacy and durability of treatment response, including combinations with ARPIs, chemotherapy, immunotherapy, and targeted therapies. Further, efforts are underway to expand the role of PSMA-directed RNT to earlier stages of disease including hormone-sensitive and localized prostate cancer. In this review, we discuss the rationale and ongoing RNT combination therapeutic trials in prostate cancer and summarize the efficacy and toxicity associated with RNT.

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Section: Rnt Studies In Combination With Surgerymentioning

confidence: 86%

Section: Rnt Studies In Combination With Surgerymentioning

confidence: 86%

Novel radionuclide therapy combinations in prostate cancer

et al. 2023

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“…To evaluate the predictive effect after treatment, a trial involving 301 patients demonstrated that the extent of bone metastases and their changes were potential markers for predicting treatment outcomes in patients with mCRPC ( 18 ). A previous single-arm phase I study of 177 Lu-PSMA-I&T neoadjuvant therapy in high-risk prostate cancer before radical prostatectomy included 14 patients with high-critical-limited-stage prostate cancer, defined as PSA >20 ng/ml, biopsy Gleason score ≥8, or clinical T stage ≥3a, who tested positive for PSMA between December 2019 and December 2021( 19 ). Furthermore, two or three doses of 177 Lu-PSMA-I&T (7.4 GBq) were administered at 2-week intervals, and surgery (including lymph node dissection) was performed 4 weeks after the final dose.…”

Section: Application Of 177 Lu In Prostate Cancermentioning

confidence: 99%

Current clinical application of lutetium‑177 in solid tumors (Review)

Niu,

Fan,

Lin

et al. 2024

Exp Ther Med

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Radionuclide-based therapy represents a novel treatment regimen for tumors. Among these therapies, lutetium-177 ( 177 Lu) has gained significant attention due to its stability and safety, as well as its ability to emit both γ and β rays, allowing for both imaging with single photon emission computed tomography and tumor treatment. As a result, 177 Lu can be used for both diagnosis and treatment for diseases such as prostatic and gastric cancer. Therefore, based on the available data, the present review provides a brief overview of the clinical applications of 177 Lu-targeted radionuclide therapy in metastatic prostate cancer, neuroendocrine tumors and other types of solid tumors, and highlights the current therapeutic effect, reduction in damage to normal tissues and future research directions, including the development of new nuclides and the application of more nuclides in different tumors. In the future, such treatments could be used in more tumors.

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“…Participants will be followed up to three years and secondary outcomes such as, pathological response, surgical safety and biochemical recurrence will be evaluated as well. In this context, Golan et al [46 ▪ ] described results from a single-arm phase 1 trial aimed at assessing safety and early outcomes of neoadjuvant Lu-PSMA treatment in high-risk PCa patients. A total of 14 patients received two to three Lu-PSMA doses at two weeks of interval.…”

Section: Prostate-specific Membrane Antigen-targeted Therapiesmentioning

confidence: 99%

The role of nuclear medicine tracers for prostate cancer surgery: from preoperative to intraoperative setting

Barletta,

Ceci,

van den Bergh

et al. 2023

Current Opinion in Urology

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Purpose of review There has been a growing interest in the use of novel molecular imaging modalities for the management of prostate cancer (PCa), spanning from diagnostic to therapeutic settings. The aim of this review is to provide a comprehensive overview of recently published studies investigating the use of novel nuclear medicine tracers across different stages of PCa management. Recent findings Emerging evidence supports the use of molecular imaging for preoperative staging of PCa, where prostate-specific membrane antigen (PSMA) PET has shown superior accuracy compared to conventional imaging for the detection of nodal and distant metastases, which needs to be translated to new risk stratification. A role for PSMA PET has been proposed for PCa diagnosis, with local activity associated with histology. Surgical guidance, using either visual feedback or gamma-ray detectors to identify tissues with accumulated radio-labeled tracers, may improve the ability to resect locoregional diseases and thus maximize oncological control. PSMA targeted therapy (Lu-PSMA) has been mainly investigated in the castration-resistant setting, but might have a role in earlier settings such as neoadjuvant treatment. Summary Novel molecular imaging using PSMA-based tracers could significantly improve PCa management in the diagnosis, staging, and intraoperative guidance settings, potentially leading to personalized and effective treatment decisions.

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Neoadjuvant 177Lu-PSMA-I&T Radionuclide Treatment in Patients with High-risk Prostate Cancer Before Radical Prostatectomy: A Single-arm Phase 1 Trial

Cited by 23 publications

References 34 publications

Novel radionuclide therapy combinations in prostate cancer

Novel radionuclide therapy combinations in prostate cancer

Current clinical application of lutetium‑177 in solid tumors (Review)

The role of nuclear medicine tracers for prostate cancer surgery: from preoperative to intraoperative setting

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