TriangleNCT00005044 · STUDY IN CONTEXT
Hormone Therapy and Radiation Therapy in Treating Patients With 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
Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.
Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.
Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.
Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF \[protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy\], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.
Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported.
Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- qol key
- qol-0006
- source section id
- NCT00005044-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
- measure definition
- Acute drug therapy and radiation (\<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.
- time frame
- From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Eligible patients with adverse event data in corresponding time frame (during hormone therapy and \<=90 days from RT start; \> 90 days from RT start)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- trial label
- Hormone Therapy and Radiation Therapy in Treating Patients With 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
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0000
- source section id
- NCT00005044-om-0000
- source outcome index
- 0
- endpoint
- Disease-specific Survival (DSS) (10-year Rates Reported)
- endpoint definition
- Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.
- time origin
- From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients with follow-up data
- 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
- NCT00005044
- outcome key
- om-0001
- source section id
- NCT00005044-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS) (10-year Rates Reported)
- endpoint definition
- Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.
- time origin
- From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients with follow-up data
- 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
- NCT00005044
- outcome key
- om-0002
- source section id
- NCT00005044-om-0002
- source outcome index
- 2
- endpoint
- Disease-free Survival (DFS) (10-year Rates Reported)
- endpoint definition
- Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.
- time origin
- From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients without follow-up data
- 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
- NCT00005044
- outcome key
- om-0003
- source section id
- NCT00005044-om-0003
- source outcome index
- 3
- endpoint
- Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)
- endpoint definition
- Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF \[protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy\], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.
- time origin
- From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients with follow-up data
- 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
- NCT00005044
- outcome key
- om-0004
- source section id
- NCT00005044-om-0004
- source outcome index
- 4
- endpoint
- Time to First Biochemical Failure (BF) (10-year Rates Reported)
- endpoint definition
- Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported.
- time origin
- From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients with follow-up data
- 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
- NCT00005044
- outcome key
- om-0005
- source section id
- NCT00005044-om-0005
- source outcome index
- 5
- endpoint
- Time to Second Biochemical Failure (SBF) (10-year Rates Reported)
- endpoint definition
- Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.
- time origin
- From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients with follow-up data
- 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
- NCT00005044
- outcome key
- om-0000
- arm key
- OG000
- arm label
- TAS x 8 Weeks
- regimen
- Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 752
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0000
- arm key
- OG001
- arm label
- TAS x 28 Weeks
- regimen
- TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 737
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0001
- arm key
- OG000
- arm label
- TAS x 8 Weeks
- regimen
- Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 752
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0001
- arm key
- OG001
- arm label
- TAS x 28 Weeks
- regimen
- TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 737
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0002
- arm key
- OG000
- arm label
- TAS x 8 Weeks
- regimen
- Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 752
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0002
- arm key
- OG001
- arm label
- TAS x 28 Weeks
- regimen
- TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 737
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0003
- arm key
- OG000
- arm label
- TAS x 8 Weeks
- regimen
- Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 752
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0003
- arm key
- OG001
- arm label
- TAS x 28 Weeks
- regimen
- TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 737
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0004
- arm key
- OG000
- arm label
- TAS x 8 Weeks
- regimen
- Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 752
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0004
- arm key
- OG001
- arm label
- TAS x 28 Weeks
- regimen
- TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 737
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0005
- arm key
- OG000
- arm label
- TAS x 8 Weeks
- regimen
- Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 752
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- outcome key
- om-0005
- arm key
- OG001
- arm label
- TAS x 28 Weeks
- regimen
- TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
- analyzed count
- 737
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00005044-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- harm key
- EG000
- source section id
- NCT00005044-ae
- event group key
- EG000
- event group label
- TAS x 8 Weeks
- serious affected
- 121
- serious at risk
- 747
- other affected
- 695
- other at risk
- 747
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Eligible patients with adverse event data are included. 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
- NCT00005044
- harm key
- EG001
- source section id
- NCT00005044-ae
- event group key
- EG001
- event group label
- TAS x 28 Weeks
- serious affected
- 109
- serious at risk
- 735
- other affected
- 707
- other at risk
- 735
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Eligible patients with adverse event data are included. 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer
- nct id
- NCT00005044
- qol key
- qol-0006
- source section id
- NCT00005044-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
- measure definition
- Acute drug therapy and radiation (\<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.
- time frame
- From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Eligible patients with adverse event data in corresponding time frame (during hormone therapy and \<=90 days from RT start; \> 90 days from RT start)
- 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