A Phase 2/3 interventional study of Luteinizing hormone-releasing hormone (LHRH) and Docetaxel in Prostate Cancer, sponsored by Proton Collaborative Group. Terminated at 3 sites in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-14.
Sponsored by Proton Collaborative Group · Phase 2/3, Interventional, and Treatment
The purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy.
The recommended treatment for a high risk prostate cancer consists of a combination of radiation therapy and androgen suppression for 2-3 years. Recent studies have shown a survival advantage for chemotherapy for prostate cancer. Chemotherapy has already been successfully integrated in the treatment of other cancer types and is our belief that chemotherapy will prove to be beneficial for patients with high risk prostate cancer. However, a clinical study is necessary to compare the results good or bad of chemotherapy with radiation therapy.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 2 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Proton Collaborative Group is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Drug: Luteinizing hormone-releasing hormone (LHRH) · Other: Conformal Radiation Therapy (RT)
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).
Drug: Luteinizing hormone-releasing hormone (LHRH) · Drug: Docetaxel · Other: Conformal Radiation Therapy (RT)
Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Also known as: -Androgen Suppression, -Androgen Deprivation, -Zoladex, -Lupron, -Eligard, -Viadur
Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
Also known as: -taxotere, -docetaxel
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).
Also known as: Intensity-modulated Radiation Therapy (IMRT), Proton Therapy, Particle Therapy
Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm
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).
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.
Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm
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.
Time frame: at 5 years
Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.
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).
Time frame: 2 years
Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.
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.
Time frame: at 5 years
Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events
Assessment will be performed using CTCAE v 4 criteria.
Time frame: at 6 months
Assessment of Number of GI and GU Adverse Events
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.
Time frame: at 3 years
Assessment of Total Number of Local/Distant Failures
The total number of local/distant failures will be assessed.
Time frame: at time of study closure (22 months)
Assessment of Impotence by Summation of Relative Scores for Sexual Function From the EPIC Quality of Life Instrument.
unable to assess due to lack of data
Time frame: Up to 10 years
Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.
The total number of subjects with salvage androgen deprivation use will be assessed.
Time frame: At study closure (22 months)
Assessment of Total Number of Survival Events With Comparison of Group Arms
The number of deaths in both arms will be assessed.
Time frame: at study closure (22 months)
Assessment of Total Number of Biochemical Failure Events
The number of biochemical failure events will be assessed on both arms.
Time frame: at study closure (22 months)
Assessment of Quality of Life - Summation of Relative Scores From the EPIC Instrument.
unable to assess due to lack of data
Time frame: Up to 10 years
| Milestone | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
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).
| failure events | Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) | Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone |
|---|---|---|
| Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm | 0 | 0 |
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.
No measurements were reported for this outcome.
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).
| events | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH |
|---|---|---|
| Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events. | 0 | 0 |
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.
No measurements were reported for this outcome.
Assessment will be performed using CTCAE v 4 criteria.
| incidences | Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) | Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone |
|---|---|---|
| Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events | 0 | 1 |
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.
No measurements were reported for this outcome.
The total number of local/distant failures will be assessed.
| participants | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH |
|---|---|---|
| Assessment of Total Number of Local/Distant Failures | 0 | 0 |
unable to assess due to lack of data
No measurements were reported for this outcome.
The total number of subjects with salvage androgen deprivation use will be assessed.
| participants | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH |
|---|---|---|
| Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms. | 0 | 0 |
The number of deaths in both arms will be assessed.
| participants | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH |
|---|---|---|
| Assessment of Total Number of Survival Events With Comparison of Group Arms | 0 | 0 |
The number of biochemical failure events will be assessed on both arms.
| participants | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH |
|---|---|---|
| Assessment of Total Number of Biochemical Failure Events | 0 | 0 |
unable to assess due to lack of data
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiation + 24mo LHRH | — | 0/1 (0%) | 1/1 (100%) |
| Radiation + Chemo + 6mo LHRH | — | 0/1 (0%) | 1/1 (100%) |
| Event | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH |
|---|---|---|
| urinary retentionRenal and urinary disorders | 1/1 | 0/1 |
| agitationPsychiatric disorders | 1/1 | 0/1 |
| fatigueGeneral disorders | 1/1 | 0/1 |
| hot flashesVascular disorders | 1/1 | 0/1 |
| dermatitis radiationSkin and subcutaneous tissue disorders | 1/1 | 1/1 |
| urinary incontinenceRenal and urinary disorders | 1/1 | 1/1 |
| urinary tract painRenal and urinary disorders | 0/1 | 1/1 |
| hematuriaRenal and urinary disorders | 0/1 | 1/1 |
| diarrheaGastrointestinal disorders | 0/1 | 1/1 |
| Age, Categorical(Participants) | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH | Total |
|---|---|---|---|
| Mean | 53 (53 to 53) | 72 (72 to 72) | 62.5 (53 to 72) |
| Sex: Female, Male(Participants) | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 0 | 1 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Radiation + 24mo LHRH | Radiation + Chemo + 6mo LHRH | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Proton Collaborative Group