NCT00002597 · STUDY IN CONTEXT

Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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 (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method.

All eligible patients.

→

secondary · POSTED

Disease-specific failure is defined as death certified as due to prostate cancer (by central review), death due to complications of treatment (irrespective of malignancy status), death from unknown causes with active malignancy, or death from unknown causes with previously documented relapse (either clinical or biochemical). Survival rates were estimated by means of cumulative incidence functions.

All eligible patients.

→

secondary · POSTED

Local progression defined as documented local progression as determined by clinical exam . Failure rates were estimated by means of cumulative incidence functions.

All eligible patients.

→

secondary · POSTED

Failure is defined as documented metastatic disease. Failure rates were estimated by means of cumulative incidence functions.

All eligible patients.

→

secondary · POSTED

The Phoenix definition of biochemical failure was used - an increase in the prostate-specific antigen (PSA) level of \>2 ng per milliliter above the nadir. Failure rates were estimated by means of cumulative incidence functions.

All eligible patients.

→

secondary · POSTED

Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions.

All eligible patients.

→

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
nct id: NCT00002597
trial label: Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0000
source section id
NCT00002597-om-0000
source outcome index
0
endpoint
Overall Survival Rate (10-year)
endpoint definition
Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method.
time origin
From date of randomization to 10 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients.
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
nct id
NCT00002597
outcome key
om-0001
source section id
NCT00002597-om-0001
source outcome index
1
endpoint
Disease-specific Survival Rate (10 Years)
endpoint definition
Disease-specific failure is defined as death certified as due to prostate cancer (by central review), death due to complications of treatment (irrespective of malignancy status), death from unknown causes with active malignancy, or death from unknown causes with previously documented relapse (either clinical or biochemical). Survival rates were estimated by means of cumulative incidence functions.
time origin
From registration to 10 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients.
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
nct id
NCT00002597
outcome key
om-0002
source section id
NCT00002597-om-0002
source outcome index
2
endpoint
Local Progression Rate (10 Years)
endpoint definition
Local progression defined as documented local progression as determined by clinical exam . Failure rates were estimated by means of cumulative incidence functions.
time origin
From registration to 10 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients.
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
nct id
NCT00002597
outcome key
om-0003
source section id
NCT00002597-om-0003
source outcome index
3
endpoint
Distant Failure Rate (10 Years)
endpoint definition
Failure is defined as documented metastatic disease. Failure rates were estimated by means of cumulative incidence functions.
time origin
From registration to 10 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients.
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
nct id
NCT00002597
outcome key
om-0004
source section id
NCT00002597-om-0004
source outcome index
4
endpoint
Biochemical Failure Rate (10 Years)
endpoint definition
The Phoenix definition of biochemical failure was used - an increase in the prostate-specific antigen (PSA) level of \>2 ng per milliliter above the nadir. Failure rates were estimated by means of cumulative incidence functions.
time origin
From registration to 10 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients.
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
nct id
NCT00002597
outcome key
om-0005
source section id
NCT00002597-om-0005
source outcome index
5
endpoint
Clinical Relapse Rate (10 Years)
endpoint definition
Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions.
time origin
From registration to 10 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients.
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
nct id
NCT00002597
outcome key
om-0000
arm key
OG000
arm label
Hormone Therapy + Radiation Therapy
regimen
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
analyzed count
987
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0000
arm key
OG001
arm label
Radiation Therapy Alone
regimen
Radiation therapy alone
analyzed count
992
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0001
arm key
OG000
arm label
Hormone Therapy + Radiation Therapy
regimen
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
analyzed count
987
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0001
arm key
OG001
arm label
Radiation Therapy Alone
regimen
Radiation therapy alone
analyzed count
992
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0002
arm key
OG000
arm label
Hormone Therapy + Radiation Therapy
regimen
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
analyzed count
987
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0002
arm key
OG001
arm label
Radiation Therapy Alone
regimen
Radiation therapy alone
analyzed count
992
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0003
arm key
OG000
arm label
Hormone Therapy + Radiation Therapy
regimen
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
analyzed count
987
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0003
arm key
OG001
arm label
Radiation Therapy Alone
regimen
Radiation therapy alone
analyzed count
992
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0004
arm key
OG000
arm label
Hormone Therapy + Radiation Therapy
regimen
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
analyzed count
987
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0004
arm key
OG001
arm label
Radiation Therapy Alone
regimen
Radiation therapy alone
analyzed count
992
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0005
arm key
OG000
arm label
Hormone Therapy + Radiation Therapy
regimen
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
analyzed count
987
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
outcome key
om-0005
arm key
OG001
arm label
Radiation Therapy Alone
regimen
Radiation therapy alone
analyzed count
992
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00002597-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00002597
harm key
EG000
source section id
NCT00002597-ae
event group key
EG000
event group label
Neoadjuvant TAS 2 Months Before and During RT
serious affected
33
serious at risk
1003
other affected
975
other at risk
1003
frequency threshold
5
collection period
Source null
event definition
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
undenominated note
Source null
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
nct id
NCT00002597
harm key
EG001
source section id
NCT00002597-ae
event group key
EG001
event group label
Radiation Therapy Alone
serious affected
16
serious at risk
1003
other affected
955
other at risk
1003
frequency threshold
5
collection period
Source null
event definition
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
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