Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	The proportion of patients achieving PSA decline of ≥ 30% from baseline will be considered a response.	Up to 6-8 cycles of treatment. Each cycle is 21 days.	To evaluate the antitumor activity of bortezomib in patients with metastatic castration-resistant prostate cancer (mCRPC) with PTEN deletion as assessed by prostate-specific antigen (PSA) 30% response rate.
Secondary	The proportion of patients achieving PSA decline of ≥ 50% (PSA50) compared to the baseline value prior to starting study treatment.	Up to 6-8 cycles of treatment. Each cycle is 21 days.	To assess the PSA 50% response rate in the study population.
Secondary	Duration of PSA response as defined as the interval of time from PSA decline of ≥ 50% to PSA progression as defined by PCWG3 criteria.	Until progression or end of study. Study anticipated to be about 4 years.	To assess duration of PSA response in the study population.
Secondary	PSA PFS as defined as the interval of time from study drug initiation to the time of PSA progression as defined by PCWG3 criteria.	Until progression or end of study. Study anticipated to be about 4 years.	To assess the PSA progression-free survival (PSA PFS) in the study population.
Secondary	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	Until progression or end of study. Study anticipated to be about 4 years.	To assess the objective response rate (ORR) in the study population.
Secondary	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.	Until progression or end of study. Study anticipated to be about 4 years.	To assess the duration of response (DoR) in the study population.
Secondary	rPFS as defined as the time from study drug initiation to the time of radiographic disease progression as assessed by PCWG3 modified RECIST 1.1 or death from any cause.	Until progression or end of study. Study anticipated to be about 4 years.	To assess radiographic progression-free survival (rPFS)
Secondary	PFS as defined as the time from study drug initiation to the time of disease progression (clinical or radiological as assessed by PCWG3 modified RECIST 1.1) or death from any cause.	Until progression or end of study. Study anticipated to be about 4 years.	To assess PFS in the study population.
Secondary	OS as defined as the time from study drug initiation until death from any cause.	Until end of study. Study anticipated to be about 4 years.	To assess overall survival (OS) in this study population.
Secondary	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.	Until end of study. Study anticipated to be about 4 years.	To assess the safety of bortezomib in study population.
Secondary	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).	Until end of study. Study anticipated to be about 4 years.	To assess the safety of bortezomib in study population.
Secondary	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.	Until end of study. Study anticipated to be about 4 years.	To assess the safety of bortezomib in study population.
Secondary	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.	Until end of study. Study anticipated to be about 4 years.	To assess the safety of bortezomib in study population.
Secondary	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.	Until end of study. Study anticipated to be about 4 years.	To assess the safety of bortezomib in study population.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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