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Proteasome Inhibitor

Bortezomib for Prostate Cancer (BORXPTEN Trial)

Q: How does the safety profile of Bortezomib compare to other medications?

<p>The safety of Bortezomib, as evaluated by our team at Power scored a 2. This rating is due to Phase 2 data indicating the drug's low risk profile but lack of efficacy evidence.</p>

Q: Is participation in this research project available to the public currently?

<p>Information posted on clinicaltrials.gov reveals that, while initially published in December 1st 2023 and last modified on September 7th 2023, this trial is currently not recruiting new patients. However, 1281 other trials are actively enrolling participants at the present moment.</p>

Phase 2

Recruiting

Led By Umang Swami, MD, MS

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status ≤ 2

Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until end of study. study anticipated to be about 4 years.

Awards & highlights

BORXPTEN Trial Summary

This trial tests if a drug, bortezomib, can help treat prostate cancer in those with PTEN deletion. Patients receive 8 cycles of injections to see if it helps reduce PSA.

Who is the study for?

Men over 18 with advanced prostate cancer resistant to hormone therapy and no prior mCRPC treatments can join. They must have a life expectancy over 3 months, treated or stable other cancers, good organ function, and agree to use contraception. Excluded are those with severe heart issues, active infections like TB or hepatitis B/C, recent major surgery or therapies, brain metastases, uncontrolled blood pressure or HIV.Check my eligibility

What is being tested?

The trial tests bortezomib's effectiveness in reducing PSA levels in men with metastatic castration-resistant prostate cancer that has a specific genetic change (PTEN deletion). Participants will receive subcutaneous injections of bortezomib for up to eight cycles lasting about three weeks each.See study design

What are the potential side effects?

Bortezomib may cause side effects such as nerve damage (neuropathy), fatigue, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding problems. Heart rhythm issues could also occur.

BORXPTEN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My prostate cancer is confirmed without being a small cell type.

Select...

I have undergone orchiectomy or am on hormone therapy with low testosterone levels.

Select...

My cancer has a PTEN gene deletion.

Select...

I have been treated with medications like abiraterone or enzalutamide for my cancer.

Select...

I am a man aged 18 or older.

BORXPTEN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until end of study. study anticipated to be about 4 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until end of study. study anticipated to be about 4 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and until end of study. study anticipated to be about 4 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The proportion of patients achieving PSA decline of ≥ 30% from baseline will be considered a response.

Secondary outcome measures

DoR as defined as the interval of time from the date of initial documented response (PR or better per PCWG3-modified RECIST 1.1) to the time of progression, the start of a new therapy, or death from any cause.

Duration of PSA response as defined as the interval of time from PSA decline of ≥ 50% to PSA progression as defined by PCWG3 criteria.

ORR as defined as the proportion of patients with measurable disease achieving a confirmed partial response (PR) and complete response (CR) as assessed by PCWG3-modified RECIST

+10 more

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00006184

100%

Injection site reaction

40%

Fatigue (asthenia, lethargy, malaise)

30%

Pruritus

30%

Platelets

30%

Chest pain (non-cardiac and non-pleuritic)

30%

Bone pain

30%

Headache

30%

Myalgia (muscle ache)

30%

SGPT (ALT)

30%

Abdominal pain or cramping

20%

Alkaline phosphatase

20%

Hypokalemia

20%

Dizziness/lightheadedness

20%

Arthralgia (joint pain)

20%

Hypomagnesemia

20%

Pain - Other

20%

Rash/desquamation

20%

Rigors/chills

20%

SGOT (AST)

10%

Hypoalbuminemia

10%

Hypocalcemia

10%

Hot flashes/flushes

10%

Hypophosphatemia

10%

Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)

10%

Lymphopenia

10%

Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis

10%

Dry skin

10%

Constipation

10%

Hypotension

10%

Joint, muscle, or bone (osseous)- Other (Calf cramping)

10%

Hypercalcemia

10%

Skin-Other (Drug reaction face, hands, neck)

10%

Hematologic-Other (Splenomegaly in donor-resolved)

10%

Dyspnea (shortness of breath)

10%

Rash/desquamation for BMT

10%

Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)

100%

80%

60%

40%

20%

Study treatment Arm

Donor - Vaccination Generation Group

Recipient - Chemotherapy Group

BORXPTEN Trial Design

1Treatment groups

Experimental Treatment

Group I: BortezomibExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 2

~1090

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,778,879 Total Patients Enrolled

8 Trials studying Prostate Cancer

5,349 Patients Enrolled for Prostate Cancer

Umang Swami, MD, MSPrincipal InvestigatorUniversity of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does the safety profile of Bortezomib compare to other medications?

"The safety of Bortezomib, as evaluated by our team at Power scored a 2. This rating is due to Phase 2 data indicating the drug's low risk profile but lack of efficacy evidence."

Answered by AI

Is participation in this research project available to the public currently?

"Information posted on clinicaltrials.gov reveals that, while initially published in December 1st 2023 and last modified on September 7th 2023, this trial is currently not recruiting new patients. However, 1281 other trials are actively enrolling participants at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN Deletion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029998.