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← Talzenna: metastatic Prostate Cancer

NCT00309985 · STUDY IN CONTEXT

Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer

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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.

All randomized patients

→

secondary · POSTED

Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.

All randomized patients.

→

secondary · POSTED

Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.

All randomized patients.

→

secondary · POSTED

PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.

All randomized patients

→

secondary · POSTED

PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.

All randomized patients

→

secondary · POSTED

The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.

Patients with both baseline and 3-month QOL assessments are included in this analysis.

→

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

FACT · QOL Change From Baseline to 3 Months

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-talzenna-52aec61d
nct id
NCT00309985
qol key
qol-0005
source section id
NCT00309985-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact-p' in the study's own wording
scale title
QOL Change From Baseline to 3 Months
measure definition
The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
time frame
Assessed at baseline and 3 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores represent better
population note
Patients with both baseline and 3-month QOL assessments are included in this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-talzenna-52aec61d
nct id
NCT00309985
trial label
Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
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
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0000
    source section id
    NCT00309985-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.
    time origin
    Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0001
    source section id
    NCT00309985-om-0001
    source outcome index
    1
    endpoint
    Time to Clinical Progression
    endpoint definition
    Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
    time origin
    Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0002
    source section id
    NCT00309985-om-0002
    source outcome index
    2
    endpoint
    Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)
    endpoint definition
    Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
    time origin
    Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0003
    source section id
    NCT00309985-om-0003
    source outcome index
    3
    endpoint
    Proportion of Patients With PSA Complete Response (CR) at 6 Months
    endpoint definition
    PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.
    time origin
    Assessed at 6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0004
    source section id
    NCT00309985-om-0004
    source outcome index
    4
    endpoint
    Proportion of Patients With PSA Complete Response (CR) at 12 Months
    endpoint definition
    PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.
    time origin
    Assessed at 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0005
    source section id
    NCT00309985-om-0005
    source outcome index
    5
    endpoint
    QOL Change From Baseline to 3 Months
    endpoint definition
    The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
    time origin
    Assessed at baseline and 3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients with both baseline and 3-month QOL assessments are included in this analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Androgen-Deprivation Therapy and Docetaxel
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    397
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Androgen-Deprivation Therapy Alone
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    analyzed count
    393
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Androgen-Deprivation Therapy and Docetaxel
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    397
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Androgen-Deprivation Therapy Alone
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    analyzed count
    393
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Androgen-Deprivation Therapy and Docetaxel
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    397
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Androgen-Deprivation Therapy Alone
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    analyzed count
    393
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Androgen-Deprivation Therapy and Docetaxel
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    397
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Androgen-Deprivation Therapy Alone
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    analyzed count
    393
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Androgen-Deprivation Therapy and Docetaxel
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    397
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Androgen-Deprivation Therapy Alone
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    analyzed count
    393
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Androgen-Deprivation Therapy and Docetaxel
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    334
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Androgen-Deprivation Therapy Alone
    regimen
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    analyzed count
    299
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00309985-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    harm key
    EG000
    source section id
    NCT00309985-ae
    event group key
    EG000
    event group label
    Arm A
    serious affected
    116
    serious at risk
    390
    other affected
    38
    other at risk
    390
    frequency threshold
    5
    collection period
    Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
    event definition
    Submission of late adverse events is required at follow-up visits up to 10 years.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    harm key
    EG001
    source section id
    NCT00309985-ae
    event group key
    EG001
    event group label
    Arm B
    serious affected
    12
    serious at risk
    392
    other affected
    1
    other at risk
    392
    frequency threshold
    5
    collection period
    Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
    event definition
    Submission of late adverse events is required at follow-up visits up to 10 years.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-talzenna-52aec61d
    nct id
    NCT00309985
    qol key
    qol-0005
    source section id
    NCT00309985-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'fact-p' in the study's own wording
    scale title
    QOL Change From Baseline to 3 Months
    measure definition
    The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
    time frame
    Assessed at baseline and 3 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher scores represent better
    population note
    Patients with both baseline and 3-month QOL assessments are included in this analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice