Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06029998

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

Led by University of Utah · Updated on 2025-11-28

22

Participants Needed

1

Research Sites

246 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male subject aged 6 18 years
  • Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
  • Prior orchiectomy and/or ongoing androgen-deprivation therapy with 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), including abiraterone acetate, enzalutamide, apalutamide, or darolutamide
  • No prior systemic chemotherapy treatment for mCRPC
  • Available tumor tissue for testing or biopsy, or ATAD1 immunohistochemistry results available
  • PTEN deletion confirmed on next generation sequencing
  • Progressive mCRPC as determined by treating investigator
  • ECOG Performance Status of 2 or less
  • Adequate organ function including neutrophil count ≥1500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥10 g/dL, and total bilirubin ≤1.5 times ULN
  • Agreement to use medically accepted contraception during and for 4 months after study treatment if sexually active and fertile
  • Recovery to baseline or grade 1 or less from prior treatment toxicities unless clinically nonsignificant and stable
  • Able and willing to provide informed consent
  • Life expectancy greater than 3 months
Not Eligible

You will not qualify if you...

  • Neuropathy grade 2 or higher
  • Receiving other investigational agents
  • Prior systemic anti-cancer or investigational therapy within 14 days or five half-lives before study treatment
  • Prior radiotherapy within 14 days before starting study treatment except for palliative radiation without significant toxicities
  • Major surgery within 14 days before starting study drug or not fully recovered from major surgery
  • Diagnosis of another malignancy within 2 years before enrollment except adequately treated cancers not requiring therapy
  • Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks without symptoms or corticosteroids
  • Uncontrolled significant illnesses including severe cardiovascular disorders, recent stroke or thromboembolic events, abnormal ECG with QTcF >500 ms, congenital long QT, low ejection fraction, or uncontrolled hypertension
  • Conditions contraindicating participation due to safety or compliance concerns
  • Known HIV infection with detectable viral load within 6 months before treatment (undetectable viral load on therapy allowed)
  • Active systemic infections including tuberculosis, hepatitis B or C unless past/resolved infections as specified
  • Medical, psychiatric, cognitive, or other conditions impairing consent or protocol adherence
  • Known severe hypersensitivity to the investigational product or components
  • Use of prohibited medications without appropriate washout before treatment start

AI-Screening

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Trial Site Locations

Total: 1 location

1

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

S

Susan Sharry

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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