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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00041474 | Other Identifier | University of Michigan Medical School IRB |
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| Name | Class |
|---|---|
| Fox Chase Cancer Center | OTHER |
| Cedars-Sinai Medical Center | OTHER |
| Washington University School of Medicine | OTHER |
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The purpose of this study is to evaluate the safety and tolerability of using radiation therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5 radiation fraction to treat prostate cancer over 2-3 weeks as compared to the typical treatment which would involve 40-42 smaller radiation fractions over 8-9 weeks. This type of radiation using a smaller number of treatments has been called hypofractionated radiation therapy.
The Calypso is a new technique which uses beacons implanted into the prostate which using radio signals are able to localize and track the position of the prostate continuously during radiation therapy. The Calypso system has been approved by the United States Food and Drug Administration (FDA) for guidance of radiation therapy during the treatment of prostate cancer and is being utilized all across the United States. However, it has not been tested for hypofractionated radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL) | To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks. Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months | To estimate one year prostate specific antigen (PSA)control of prostate cancer when treated with stereotactic body radiotherapy (SBRT) using continuous real-time evaluation of prostate motion. | 1 Year |
| Relation Between Dose Distribution and Toxicities. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Spratt, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Radiological Associates of Sacremento | Sacramento | California | 95815 | United States | ||
| University of Michigan Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Treatment | Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Treatment | Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL) | To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks. Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months. | Posted | Number | percentage of patients | 24 months |
|
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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 Treatment | Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Spratt, M.D. | University of Michigan Comprehensive Cancer Center | 734-936-9630 | sprattda@med.umich.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
To look at the relation between dose distribution and toxicities and to determine if reconstructed delivered doses are more predictive of toxicity than planned doses. |
| 5 years |
| Relation Between Reconstructed Delivered Dose Distributions. | To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities. | 5 years |
| Frequency of Required Interventions. | To assess the frequency of required interventions (interruptions) based on real-time prostate translations and rotations to verify that the proposed planning target volume(PTV) margins and action level are appropriate and practical. This will be assessed by the percentage of patients with no interventions for any fraction, the percentage of patients with 1-2 fractions interrupted and the percentage of patients with more than two fractions interrupted and the percentage of patients that had an interruption of the beam at least once for all 5 fractions. | 5 years |
| Ann Arbor |
| Michigan |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months | To estimate one year prostate specific antigen (PSA)control of prostate cancer when treated with stereotactic body radiotherapy (SBRT) using continuous real-time evaluation of prostate motion. | Posted | Number | percentage of patients | 1 Year |
|
|
|
| Secondary | Relation Between Dose Distribution and Toxicities. | To look at the relation between dose distribution and toxicities and to determine if reconstructed delivered doses are more predictive of toxicity than planned doses. | Data was not collected in full by some centers for their patients and these endpoints couldn't be analyzed. | Posted | 5 years |
|
|
| Secondary | Relation Between Reconstructed Delivered Dose Distributions. | To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities. | Data was not collected in full by some centers for their patients and these endpoints couldn't be analyzed | Posted | 5 years |
|
|
| Secondary | Frequency of Required Interventions. | To assess the frequency of required interventions (interruptions) based on real-time prostate translations and rotations to verify that the proposed planning target volume(PTV) margins and action level are appropriate and practical. This will be assessed by the percentage of patients with no interventions for any fraction, the percentage of patients with 1-2 fractions interrupted and the percentage of patients with more than two fractions interrupted and the percentage of patients that had an interruption of the beam at least once for all 5 fractions. | Posted | Number | percentage of participants | 5 years |
|
|
|
| 5 |
| 68 |
| 62 |
| 68 |
| Cardiac disorders - Other | Cardiac disorders |
|
| Restrictive cardiomyopathy | Cardiac disorders |
|
| Gastric ulcer | Gastrointestinal disorders |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders |
|
| Fracture | Injury, poisoning and procedural complications |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders |
|
| Constipation | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
|
| Fecal incontinence | Gastrointestinal disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders |
|
| Hemorrhoidal hemorrhage | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
|
| Proctitis | Gastrointestinal disorders |
|
| Rectal hemorrhage | Gastrointestinal disorders |
|
| Fatigue | General disorders |
|
| Arthritis | Musculoskeletal and connective tissue disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Libido decreased | Psychiatric disorders |
|
| Cystitis noninfective | Renal and urinary disorders |
|
| Hematuria | Renal and urinary disorders |
|
| Renal and urinary disorders - Other | Renal and urinary disorders |
|
| Urinary frequency | Renal and urinary disorders |
|
| Urinary incontinence | Renal and urinary disorders |
|
| Urinary retention | Renal and urinary disorders |
|
| Urinary tract pain | Renal and urinary disorders |
|
| Urinary urgency | Renal and urinary disorders |
|
| Erectile dysfunction | Reproductive system and breast disorders |
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| Genital edema | Reproductive system and breast disorders |
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| Perineal pain | Reproductive system and breast disorders |
|
| Prostatic pain | Reproductive system and breast disorders |
|
| Reproductive system and breast disorders - Other | Reproductive system and breast disorders |
|
| Testicular pain | Reproductive system and breast disorders |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| At least 1 interruption for all 5 fractions |
|