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The purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.
External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | Stereotactic Body Radiation Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | Stereotactic Body Radiation Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute and late genitourinary and lower gastrointestinal toxicity will be evaluated using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales, which range from 0-5, where a high score corresponds to a worse outcome/worse toxicity. Toxicity will be measured weekly during radiation, and every 6-12 months following radiation through patient interview. The acute toxicity score will be defined as the highest score obtained from measurements taken during radiation for each participant. The late toxicity score will be defined as the highest score obtained from measurements taken following completion of radiation for each participant. | Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Biochemical Disease-free Status | Patients will be followed after completion of treatment with PSA tests every 6-12 months Patients will be deemed to have "biochemical failure" if the post-treatment PSA increases by 2 ng/ml or more above the post-radiation nadir PSA. Patients who do not qualify as having "biochemical failure" will be deemed as "biochemically disease-free". | mean 41 months (range 3-84 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Weinstein, M.D. | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
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Between 2011 and 2018 patients with prostate cancer were enrolled from the Radiation Oncology clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy: Stereotactic Body Radiation Therapy | All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Between 2011 and 2018, 12 patients were enrolled and received treatment as per protocol specifications.
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 12 patients received treatment as per protocol specifications. |
| 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 | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute and late genitourinary and lower gastrointestinal toxicity will be evaluated using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales, which range from 0-5, where a high score corresponds to a worse outcome/worse toxicity. Toxicity will be measured weekly during radiation, and every 6-12 months following radiation through patient interview. The acute toxicity score will be defined as the highest score obtained from measurements taken during radiation for each participant. The late toxicity score will be defined as the highest score obtained from measurements taken following completion of radiation for each participant. | 12 participants who were enrolled in the study | Posted | Number | participants | Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity. |
|
Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.
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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 Therapy: Prostate Stereotactic Body Radiation Therapy | All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal bleeding | Gastrointestinal disorders | Systematic Assessment | One patient hospitalized for rectal bleeding after completion of XRT, but colonoscopy showed diverticulitis without evidence of radiation changes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Late Genitourinary Toxicity (Grade 1) | Renal and urinary disorders | Systematic Assessment | Frequency of urination or nocturia twice pretreatment habit/dysuria, urgency not requiring medication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geoffrey Weinstein | Sharp Healthcare | 858-939-5010 | geoffrey.weinstein@sharp.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2018 | Mar 7, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| D014565 | Urogenital Neoplasms |
| D005834 | Genital Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Radiotherapy: phase 1/2 (but no drug, biological/vaccine or combination product used)
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| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy |
All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization. |
|
|
| Secondary | Rate of Biochemical Disease-free Status | Patients will be followed after completion of treatment with PSA tests every 6-12 months Patients will be deemed to have "biochemical failure" if the post-treatment PSA increases by 2 ng/ml or more above the post-radiation nadir PSA. Patients who do not qualify as having "biochemical failure" will be deemed as "biochemically disease-free". | 12 participants who were enrolled in the study | Posted | Number | participants | mean 41 months (range 3-84 months) |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| 6 |
| 12 |
|
| Acute Genitourinary Toxicity (Grade 4) | Renal and urinary disorders | Systematic Assessment | Bladder outlet obstruction requiring temporary foley catheter placement. |
|
|
| Late Gastrointestinal Toxicity (Grade 2) | Gastrointestinal disorders | Systematic Assessment | Moderate diarrhea and colic; bowel movement > 5 times daily; excessive rectal mucus or intermittent bleeding |
|
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| D011469 |
| Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |