NCT02047253 · STUDY IN CONTEXT

Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The study will measure patient survival at 6 months but will continue to monitor overall survival as a secondary objective. The Kaplan-Meier method will be used.

8 patients did not complete treatment and were not included in the analysis.

→

primary · POSTED

Outcome measure was completed by using a count of participants.

8 patients did not complete treatment and were lost to follow up

→

secondary · POSTED

PSA levels were collected at each visit on the day of treatment. Linear regression with PSA as the dependent variable and time as the dependent variable was performed.

We were unable to collect blood specimen for PSA analysis for 1 patient.

→

secondary · POSTED

The CTC marker will be used to evaluate efficacy of response to treatment. CTC changes will include changes from unfavorable (less than or equal to 5/7.5 ml) to favorable and declines by \>30%. Three collections: before study initiation, Day 1 of Cycles 2 and 4

1 patient did not have blood draw. 27 patients had blood draws for CTC enumeration across baseline, Cycle 2 day 1 and cycle 4 day 1.

→

secondary · POSTED

Hematologic and non-hematologic toxicities will be graded. The new international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) will serve as the guideline. On Day 1 of each cycle (4 weeks) for the duration of treatment and then 30 days following the last treatment

All serious adverse events and \> grade 3 toxicities were reported for patients who received treatment with Carfilzomib

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-prostate-cancer-jevtana-f72c24a3
nct id: NCT02047253
trial label: Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 5
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
outcome key
om-0000
source section id
NCT02047253-om-0000
source outcome index
0
endpoint
Progression-free Survival (PFS)
endpoint definition
The study will measure patient survival at 6 months but will continue to monitor overall survival as a secondary objective. The Kaplan-Meier method will be used.
time origin
Baseline through 6 months for evaluating all patients
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
8 patients did not complete treatment and were not included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
outcome key
om-0001
source section id
NCT02047253-om-0001
source outcome index
1
endpoint
Overall Survival
endpoint definition
Outcome measure was completed by using a count of participants.
time origin
From baseline through 36 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
8 patients did not complete treatment and were lost to follow up
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
outcome key
om-0002
source section id
NCT02047253-om-0002
source outcome index
2
endpoint
Number of Participants With Prostate-Specific Antigen (PSA) Changes
endpoint definition
PSA levels were collected at each visit on the day of treatment. Linear regression with PSA as the dependent variable and time as the dependent variable was performed.
time origin
Baseline through 36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
We were unable to collect blood specimen for PSA analysis for 1 patient.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
outcome key
om-0003
source section id
NCT02047253-om-0003
source outcome index
3
endpoint
Number of Participants With Circulating Tumor Cell (CTC) Decline Over Three Time Points (Before Study Initiation, Day 1 of Cycles 2 and 4
endpoint definition
The CTC marker will be used to evaluate efficacy of response to treatment. CTC changes will include changes from unfavorable (less than or equal to 5/7.5 ml) to favorable and declines by \>30%. Three collections: before study initiation, Day 1 of Cycles 2 and 4
time origin
Baseline through 36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
1 patient did not have blood draw. 27 patients had blood draws for CTC enumeration across baseline, Cycle 2 day 1 and cycle 4 day 1.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
outcome key
om-0004
source section id
NCT02047253-om-0004
source outcome index
4
endpoint
Assessment of Toxicities
endpoint definition
Hematologic and non-hematologic toxicities will be graded. The new international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) will serve as the guideline. On Day 1 of each cycle (4 weeks) for the duration of treatment and then 30 days following the last treatment
time origin
Baseline through 36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All serious adverse events and \> grade 3 toxicities were reported for patients who received treatment with Carfilzomib
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
outcome key
om-0000
arm key
OG000
arm label
Carfilzomib
regimen
Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02047253-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
outcome key
om-0001
arm key
OG000
arm label
Carfilzomib
regimen
Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02047253-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
outcome key
om-0002
arm key
OG000
arm label
Carfilzomib
regimen
Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02047253-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
outcome key
om-0003
arm key
OG000
arm label
Carfilzomib
regimen
Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02047253-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
outcome key
om-0004
arm key
OG000
arm label
Carfilzomib
regimen
Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02047253-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02047253
harm key
EG000
source section id
NCT02047253-ae
event group key
EG000
event group label
Carfilzomib
serious affected
5
serious at risk
28
other affected
0
other at risk
28
frequency threshold
0
collection period
Adverse event data were collected over 36 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice