SECuRE Trial Update: Safety Review Committee Approves Continued Progress Without Changes
The SECuRE trial, focusing on the treatment of metastatic castration-resistant prostate cancer (mCRPC), has recently been confirmed to proceed without any modifications to its protocol following an interim review by the Safety Review Committee (SRC). The review highlighted the promising safety and efficacy of 67Cu-SAR-bisPSMA, a targeted radiopharmaceutical being utilized in this clinical study.
The SECuRE trial is a Phase I/IIa study evaluating 67Cu-SAR-bisPSMA for patients whose prostate cancer shows PSMA expression. It involves multiple phases, with the most recent being the Cohort Expansion Phase (Phase II), which aims to gather more data on the treatment's effectiveness and safety. With patient recruitment still actively ongoing, a total of nine patients were reviewed in the SRC's interim analysis, all of whom demonstrated evaluable data as of November 25, 2025.
The participants included in this interim review had significant previous cancer treatment histories, with a notable 55.6% having undergone more than five different anti-cancer therapies. Moreover, a majority, measuring 66.7%, presented with bone metastasis, establishing a challenging background for the trials' efficacy assessment. Treatment involved administering 67Cu-SAR-bisPSMA and in some cases, a combination with enzalutamide, an androgen receptor pathway inhibitor.
The safety analysis of 67Cu-SAR-bisPSMA remains broadly favorable, showing that most adverse events were classified as Grade 1 or 2. Notably, 33.3% of participants experienced nausea and lymphopenia, but there were no severe renal toxicities or ECG changes detected among participants thus far. These results reinforce the treatment’s tolerability, especially among a heavily pre-treated patient population.
Results related to efficacy are even more promising. Six participants had their prostate-specific antigen (PSA) levels monitored post-treatment, all demonstrating a decrease. Remarkably, 66.7% of these patients exhibited a reduction of over 50% in PSA levels, termed PSA50, while 33.3% experienced even greater drops of 80% or more (PSA80). One particular patient, who started with bone metastasis, achieved undetectable PSA levels, corroborated by imaging that reflected no detectable prostate cancer after treatment.
As the trial advances, recruitment for the Cohort Expansion Phase is set to continue throughout 2026, with plans for a Phase III registrational trial already underway based on these promising results. Clarity Pharmaceuticals, the company spearheading this trial, has expressed optimism about the future of 67Cu-SAR-bisPSMA, especially given its strong safety and efficacy profile, as well as its potential impact on the landscape of prostate cancer treatment.
The SECuRE trial findings reaffirm the significance of ongoing research in advancing treatment for prostate cancer. Clarity Pharmaceuticals remains committed to further development of 67Cu-SAR-bisPSMA, aimed at offering enhanced options for patients battling this serious disease. The data collected thus far in the SECuRE trial offers valuable insights that could pave the way for revolutionary changes in prostate cancer diagnostics and therapeutics, signifying a step forward in the fight against cancer.
As the trial progresses, continued monitoring and adaptation based on interim findings will be essential in maximizing patient outcomes and ensuring the efficacy of this promising treatment methodology.
Background of the SECuRE Trial
The SECuRE trial is a Phase I/IIa study evaluating 67Cu-SAR-bisPSMA for patients whose prostate cancer shows PSMA expression. It involves multiple phases, with the most recent being the Cohort Expansion Phase (Phase II), which aims to gather more data on the treatment's effectiveness and safety. With patient recruitment still actively ongoing, a total of nine patients were reviewed in the SRC's interim analysis, all of whom demonstrated evaluable data as of November 25, 2025.
Participant Profile
The participants included in this interim review had significant previous cancer treatment histories, with a notable 55.6% having undergone more than five different anti-cancer therapies. Moreover, a majority, measuring 66.7%, presented with bone metastasis, establishing a challenging background for the trials' efficacy assessment. Treatment involved administering 67Cu-SAR-bisPSMA and in some cases, a combination with enzalutamide, an androgen receptor pathway inhibitor.
Safety Profile
The safety analysis of 67Cu-SAR-bisPSMA remains broadly favorable, showing that most adverse events were classified as Grade 1 or 2. Notably, 33.3% of participants experienced nausea and lymphopenia, but there were no severe renal toxicities or ECG changes detected among participants thus far. These results reinforce the treatment’s tolerability, especially among a heavily pre-treated patient population.
Efficacy And Outcomes
Results related to efficacy are even more promising. Six participants had their prostate-specific antigen (PSA) levels monitored post-treatment, all demonstrating a decrease. Remarkably, 66.7% of these patients exhibited a reduction of over 50% in PSA levels, termed PSA50, while 33.3% experienced even greater drops of 80% or more (PSA80). One particular patient, who started with bone metastasis, achieved undetectable PSA levels, corroborated by imaging that reflected no detectable prostate cancer after treatment.
Future Directions
As the trial advances, recruitment for the Cohort Expansion Phase is set to continue throughout 2026, with plans for a Phase III registrational trial already underway based on these promising results. Clarity Pharmaceuticals, the company spearheading this trial, has expressed optimism about the future of 67Cu-SAR-bisPSMA, especially given its strong safety and efficacy profile, as well as its potential impact on the landscape of prostate cancer treatment.
Conclusion
The SECuRE trial findings reaffirm the significance of ongoing research in advancing treatment for prostate cancer. Clarity Pharmaceuticals remains committed to further development of 67Cu-SAR-bisPSMA, aimed at offering enhanced options for patients battling this serious disease. The data collected thus far in the SECuRE trial offers valuable insights that could pave the way for revolutionary changes in prostate cancer diagnostics and therapeutics, signifying a step forward in the fight against cancer.
As the trial progresses, continued monitoring and adaptation based on interim findings will be essential in maximizing patient outcomes and ensuring the efficacy of this promising treatment methodology.
Topics Health）
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