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enrollment goals not met
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation + 24mo luteinizing hormone-releasing hormone (LHRH) | Active Comparator | Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). |
|
| Radiation + Chemo + 6mo luteinizing hormone-releasing hormone | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luteinizing hormone-releasing hormone (LHRH) | Drug | Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events | Assessment will be performed using CTCAE v 4 criteria. | at 6 months |
| Assessment of Number of GI and GU Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Vargas, MD | Proton Collaborative Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CDH Proton Center | Warrenville | Illinois | 60555 | United States | ||
| Procure Proton Therapy Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24423462 | Derived | Guttilla A, Bortolus R, Giannarini G, Ghadjar P, Zattoni F, Gnech M, Palumbo V, Valent F, Garbeglio A, Zattoni F. Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial. Radiat Oncol. 2014 Jan 14;9:24. doi: 10.1186/1748-717X-9-24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation + 24mo LHRH | Conformal 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). |
| FG001 | Radiation + Chemo + 6mo LHRH | 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). 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation + 24mo LHRH | Conformal 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Number | failure events | 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. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiation + 24mo LHRH | Conformal 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary retention | Renal and urinary disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corey Woods | The Proton Collaborative Group | 630-836-8668 | cwoods@pcgresearch.org |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D017273 | Goserelin |
| D016729 | Leuprolide |
| C493311 | luprolide acetate gel depot |
| D000077143 | Docetaxel |
| D050397 | Radiotherapy, Intensity-Modulated |
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Docetaxel | Drug | Docetaxel 20mg/m2 IV every 7 days x 8 weeks. |
|
|
| Conformal Radiation Therapy (RT) | Other | 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). |
|
|
| at 5 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.
| at 3 years |
| Assessment of Total Number of Local/Distant Failures | The total number of local/distant failures will be assessed. | 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 | 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. | 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. | 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. | 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 | Up to 10 years |
| Oklahoma City |
| Oklahoma |
| 73142 |
| United States |
| Hampton University Proton Therapy Institute | Hampton | Virginia | 23666 | United States |
| BG001 |
| Radiation + Chemo + 6mo LHRH |
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). 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH) |
Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Conformal Radiation Therapy (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). |
| OG001 | 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). Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. Conformal Radiation Therapy (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). |
|
|
| Primary | 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. | Posted | at 5 years |
|
|
| Primary | 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). | 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). | Posted | Number | events | 2 years |
|
|
|
| Primary | 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. | This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed. | Posted | at 5 years |
|
|
| Secondary | Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events | Assessment will be performed using CTCAE v 4 criteria. | Posted | Number | incidences | at 6 months |
|
|
|
| Secondary | 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. | Posted | at 3 years |
|
|
| Secondary | Assessment of Total Number of Local/Distant Failures | The total number of local/distant failures will be assessed. | Posted | Number | participants | at time of study closure (22 months) |
|
|
|
| Secondary | 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 | unable to assess due to study termination | Posted | Up to 10 years |
|
|
| Secondary | 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. | Posted | Number | participants | At study closure (22 months) |
|
|
|
| Secondary | Assessment of Total Number of Survival Events With Comparison of Group Arms | The number of deaths in both arms will be assessed. | Posted | Number | participants | at study closure (22 months) |
|
|
|
| Secondary | Assessment of Total Number of Biochemical Failure Events | The number of biochemical failure events will be assessed on both arms. | Posted | Number | participants | at study closure (22 months) |
|
|
|
| Secondary | Assessment of Quality of Life - Summation of Relative Scores From the EPIC Instrument. | unable to assess due to lack of data | unable to assess due to study termination | Posted | Up to 10 years |
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Radiation + Chemo + 6mo LHRH | 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). 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 |
| agitation | Psychiatric disorders |
|
| fatigue | General disorders |
|
| hot flashes | Vascular disorders |
|
| dermatitis radiation | Skin and subcutaneous tissue disorders |
|
| urinary incontinence | Renal and urinary disorders |
|
| urinary tract pain | Renal and urinary disorders |
|
| hematuria | Renal and urinary disorders |
|
| diarrhea | Gastrointestinal disorders |
|
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| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D063193 | Heavy Ion Radiotherapy |