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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06029998
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    sub-cutaneous injection of bortezomib for 6-8 cycles of treatment.

Study Details

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.

Key Dates

Start date
Mar 11, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bortezomib
    bortezomib starting at a dose of 1.3 mg per square meter of the body-surface area (BSA) subcutaneously on days 1, 4, 8, and 11 in a 21-day cycle.

Primary Outcome Measure

The proportion of patients achieving PSA decline of ≥ 30% from baseline will be considered a response. [ Time Frame: Up to 6-8 cycles of treatment. Each cycle is 21 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112
Umang Swami
[email protected]
801-585-0255
Umang Swami (PRINCIPAL_INVESTIGATOR)

Find similar trials in Salt Lake City, UT

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Huntsman Cancer Institute/University of Utah· Salt Lake City, UT

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