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Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN Deletion | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN Deletion

A Phase II Study of Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN Deletion

NCT06029998•University of Utah

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the anti-tumor activity of bortezomib in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) with PTEN Deletion. The main question\[s\] it aims to answer is if the use of bortezomib will result in a decline in PSA for participants. Participants will receive a sub-cutaneous injection of bortezomib for up 8 cycles. Each cycle is about 21 days.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Male subject aged ≥ 18 years
•Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
•Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL or \<1.7 nmol/L)
•Prior treatment with at least one prior Androgen Receptor Pathway Inhibitor (ARPI), defined as second-generation anti-androgen therapies that include, but are not limited to, abiraterone acetate, enzalutamide, apalutamide, and darolutamide.
•No prior systemic chemotherapy treatment for mCRPC disease (e.g., docetaxel, or cabazitaxel).
•Available tumor tissue (archival tissue, or, if no archival tissue is available, must be able to undergo biopsy for fresh tumor tissue). If tumor tissue is unavailable, results of ATAD1 immunohistochemistry must be available.
•PTEN deletion on next generation sequencing
•Must have progressive mCRPC per the treating investigator
•ECOG Performance Status ≤ 2.
•Adequate organ function as defined as:
+10 more criteria

Exclusion Criteria

•Neuropathy grade ≥ 2
•Receiving other investigational agents.
•Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter. Patients can continue ADT and bone strengthening agents while on treatment.
•Prior radiotherapy within 14 days prior to the first dose of study treatment.
•--Note: Palliative radiation therapy may be completed up to 14 days prior to starting study therapy provided that no clinically significant treatment related toxicities are present at the time of study therapy initiation per treating investigator.
•Major surgery within 14 days prior to starting study drug or who have not fully recovered from major surgery per treating investigator.
•The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration per treating investigator (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix).
•Known brain metastases or cranial epidural disease.
•--Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment.
•Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
+15 more criteria

Locations (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

March 11, 2024

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2028

Last Updated

November 28, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

Bortezomib

DRUG

Contacts

Susan Sharry

CONTACT

801-585-3453 susan.sharry@hci.utah.edu

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN Deletion

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer