Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm
| Group | Value (failure events) |
|---|---|
| Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) | 0 |
| Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone | 0 |
Trial · Interventional
TerminatedPhase 2/3Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: enrollment goals not met
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
External Beam Radiation With or Without Chemotherapy to Treat High Risk Prostate Cancer
NCT01603420Jul 2012 to May 2014
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy.
Active comparator
Radiation + 24mo luteinizing hormone-releasing hormone (LHRH)
Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Experimental
Radiation + Chemo + 6mo luteinizing hormone-releasing hormone
Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Outcomes the sponsor listed as primary.
Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm
Time frame · No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.
Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (Prostate Specific Antigen \[PSA\] \> = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation. This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).
Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm
Time frame · at 5 years
This endpoint will be examined if decision is made to not move forward with phase 3 study. This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.
Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.
Time frame · 2 years
Assessment will be performed using CTCAE v4 criteria. This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).
Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.
Time frame · at 5 years
The events for FFF will be the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA \> = ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage androgen deprivation. This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.
Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events
Time frame · at 6 months
Assessment will be performed using CTCAE v 4 criteria.
Assessment of Number of GI and GU Adverse Events
Time frame · at 3 years
Descriptive measurements of frequency will be compiled. This study was terminated prior to the time frame of 3 years being reached. Therefore, this outcome was not assessed. Data were collected on toxicities up until study closure at 22 months. However, this timepoint was not indicated as a secondary objective in the protocol. Therefore, data was not analyzed at time of study closure.
Assessment of Total Number of Local/Distant Failures
Time frame · at time of study closure (22 months)
The total number of local/distant failures will be assessed.
Assessment of Impotence by Summation of Relative Scores for Sexual Function From the EPIC Quality of Life Instrument.
Time frame · Up to 10 years
unable to assess due to lack of data
Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.
Time frame · At study closure (22 months)
The total number of subjects with salvage androgen deprivation use will be assessed.
Assessment of Total Number of Survival Events With Comparison of Group Arms
Time frame · at study closure (22 months)
The number of deaths in both arms will be assessed.
Assessment of Total Number of Biochemical Failure Events
Time frame · at study closure (22 months)
The number of biochemical failure events will be assessed on both arms.
Assessment of Quality of Life - Summation of Relative Scores From the EPIC Instrument.
Time frame · Up to 10 years
unable to assess due to lack of data
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (failure events) |
|---|---|
| Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) | 0 |
| Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone | 0 |
| Group | Value |
|---|---|
| Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) | not posted |
| Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone | not posted |
| Group | Value (events) |
|---|---|
| Radiation + 24mo LHRH | 0 |
| Radiation + Chemo + 6mo LHRH | 0 |
| Group | Value |
|---|---|
| Radiation + 24mo LHRH | not posted |
| Radiation + Chemo + 6mo LHRH | not posted |
| Group | Value (incidences) |
|---|---|
| Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) | 0 |
| Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone | 1 |
| Group | Value |
|---|---|
| Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) | not posted |
| Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone | not posted |
| Group | Value (participants) |
|---|---|
| Radiation + 24mo LHRH | 0 |
| Radiation + Chemo + 6mo LHRH | 0 |
| Group | Value |
|---|---|
| Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) | not posted |
| Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Radiation + 24mo LHRHConformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy). | – | 0 / 1 | 1 / 1 |
| Radiation + Chemo + 6mo LHRHConformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression). Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy). | – | 0 / 1 | 1 / 1 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
No study cites this trial.
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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