A Phase 0 Study of the Pharmacokinetics and Biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds With and Without PTI-122 in Patients With Metastatic Prostate Cancer to Inform Future Phase 1 Dosing With [Ac-225]-Trillium-PSMA Radionuclide Therapy

Exploratory study in adult males with metastatic prostate cancer intended to characterize the pharmacokinetics and biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds with and without the cytoprotective agent PTI-122. Up to 36 eligible subjects will be enrolled. Additional subjects may be enrolled if there is insufficient data for evaluation, for example if the original study subjects do not complete required imaging studies for reasons unrelated to adverse events.
Up to four PSMA-Targeted [In-111]-Labeled Trillium Compounds will be evaluated. Each compound will be evaluated first without the cytoprotective agent, PTI-122, then the [In-111]-labeled Trillium Compound may be co-administered with PTI-122.

开始日期2022-12-08

申办/合作机构

Ratio Therapeutics, Inc.初创企业

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2007-11-20·Journal of clinical oncology : official journal of the American Society of Clinical Oncology1区 · 医学

American Society of Clinical Oncology Endorsement of the Cancer Care Ontario Practice Guideline on Nonhormonal Therapy for Men With Metastatic Hormone-Refractory (castration-resistant) Prostate Cancer

1区 · 医学

Review

作者: Basch, Ethan M. ; Scher, Howard I. ; Beer, Tomasz M. ; Carducci, Michael A. ; Higano, Celestia S. ; Hussain, Maha H.A. ; Somerfield, Mark R.

Purpose:

In 2006, the American Society of Clinical Oncology (ASCO) Board of Directors (BOD) approved a policy and a set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations.

Methods:

The Cancer Care Ontario (CCO) Guideline on Non-Hormonal Therapy for Men With Metastatic Hormone-Refractory Prostate Cancer (HRPC) was reviewed for developmental rigor by methodologists. An ad hoc prostate cancer guideline review panel consisting of prostate cancer experts reviewed the content.

Results:

The ASCO ad hoc prostate cancer guideline review panel concurred that the recommendations are clear, thorough, based on the most relevant scientific evidence in this content area, and present options that will be acceptable to patients. The CCO guideline was subsequently endorsed by the ASCO BOD. The guideline recommends the use of docetaxel, prednisone/hydrocortisone, and/or mitoxantrone in specific settings. Docetaxel-based chemotherapy is the only treatment that has demonstrated an overall survival benefit in men with HRPC. The use of estramustine in combination with other cytotoxic agents is not recommended. Continued gonadal androgen suppression and discontinuance of antiandrogens is recommended for men receiving chemotherapy.

Conclusion:

The review panel agreed with the recommendations as stated in the CCO guideline, with the following qualifications: two of the ASCO content reviewers noted the importance of considering other, nonhormonal therapies in this context that are beyond the scope of this guideline. The review panel notes that CCO has published separate guidelines on radiopharmaceuticals and bisphosphonates in men with castration-resistant (ie, hormone-refractory) metastatic prostate cancer.

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