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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MC0652 | Other Identifier | Mayo Clinic Cancer Center | |
| 08-001451 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying the side effects of internal radiation therapy when given with or without external-beam radiation therapy and to see how well it works in treating patients with localized prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo high dose-rate (HDR) brachytherapy (2 fractions ≥ 5 hours apart). Beginning 2-4 weeks after completion of the first HDR brachytherapy session, patients undergo either a second session of HDR brachytherapy (2 fractions ≥ 5 hours apart) OR image-guided intensity-modulated hypofractionated external beam radiotherapy once daily 5 days a week for 3 weeks.
Quality of life is assessed at baseline, prior to the second treatment session, at 1 and 6 months after completion of treatment, every 6 months for 3 years, and then annually for 2 years.
After completion of study treatment, patients are followed at 1 and 6 months, every 6 months for 3 years, and then annually for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brachytherapy | Radiation |
| ||
| hypofractionated radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events) | Separately evaluate the tolerance of 2 radiotherapeutic regimens (HDR alone and HDR followed by hypofractionated EBRT) using the Common Terminology Criteria for Adverse Events (CTCAE v3.0). The specific adverse events (AEs) are early (i.e., within 270 days of treatment completion) grade >3 genitourinary (GU) and/or gastrointestinal (GI) AEs, late grade 2 GU and GI AEs, and late grade ≥3 GU and GI AEs. | From baseline to 3 years after registration |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events | Dose-volume limitations for organs at risk will be analyzed byassociating GU or GI AEs (both rate and severity) with dosimetric parameters using simple correlational methods. These parameters will include (1) bladder V80, V60, V50, and Dmax; (2) penile bulb median dose; (3) rectum V80, V60, V50 and Dmax; and (4) urethra V120, V110, V100, and Dmax. |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate, meeting one of the following criteria:
No known nodal (N0 or NX) or distant (M0 or MX) metastases
No pubic arch interference, as defined by either of the following:
Prostate planimetry volume ≤ 60 cc as determined by step-section transrectal ultrasound
American Urological Association voiding symptom index ≤ 12
Peak uroflow rate (Q_max) ≥ 12 cc/second
Post-void ultrasound bladder residual volume ≤ 100 cc
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas M. Pisansky, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 (HDR ± EBRT) | Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Radiation |
|
| image-guided radiation therapy | Radiation |
|
| intensity-modulated radiation therapy | Radiation |
|
| From baseline to 5 years after registration |
| Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session) | Patient preference for second treatment (group 1 or group 2) will be assessed using a Treatment Preference Questionnaire (Appendix IX) developed specifically for this study. Qualitative and quantitative analyses will be performed on patient responses to the questions posed after choosing their second treatment in an exploratory fashion. | From baseline until the end of the first treatment |
| Changes in Health-related Quality of Life Scores | A pretest-posttest design will be employed to detect changes in HRQOL scores over time. The HRQOL scores will be calculated per assessment, as appropriate. Each construct will be standardized to a range of 0-100 so that comparison across constructs is facilitated. Sets of difference scores will be computed: 1) differences between baseline and treatment completion (at 1 month post treatment follow up), and 2) differences between treatment completion and all post-treatment follow-up examinations for up to five years after finishing the protocol treatment (see Section 4.1 for specific HRQOL instruments to be completed at follow-up visits). The first analysis will allow for determination of the short-term impact of treatment on HRQOL, while the second will investigate the long-term treatment effect. Student's t-test methodology will be applied to the differences at end of treatment (1 month post treatment follow up) and at each follow-up. | From baseline to 5 years after registration |
| Freedom From Biochemical and Clinical Failure | Freedom from biochemical and clinical failure, will be analyzed using Kaplan-Meier procedures. Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from biochemical and clinical failure. | From baseline to 5 years after registration |
| Freedom From Salvage Androgen Suppression Treatment | Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from salvage androgen suppression therapy. | From baseline to 5 years after registration |
| HDR Brachytherapy |
|
| External Beam Radiotherapy (EBRT) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
All enrolled patients who were eligible and began treatment. Only 1 patient was registered to the HDR+EBRT arm. Due to protected health information, listing only 1 patient's results is contraindicated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 (HDR ± EBRT) | Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events) | Separately evaluate the tolerance of 2 radiotherapeutic regimens (HDR alone and HDR followed by hypofractionated EBRT) using the Common Terminology Criteria for Adverse Events (CTCAE v3.0). The specific adverse events (AEs) are early (i.e., within 270 days of treatment completion) grade >3 genitourinary (GU) and/or gastrointestinal (GI) AEs, late grade 2 GU and GI AEs, and late grade ≥3 GU and GI AEs. | All patients registered to a dose escalation Phase I group were analyzed for this endpoint. Only 1 patient was registered to the HDR+EBRT arm. Due to protected health information, listing only 1 patient's results is contraindicated. | Posted | Number | events | From baseline to 3 years after registration |
|
|
| ||||||||||||||||||||||||||
| Secondary | Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events | Dose-volume limitations for organs at risk will be analyzed byassociating GU or GI AEs (both rate and severity) with dosimetric parameters using simple correlational methods. These parameters will include (1) bladder V80, V60, V50, and Dmax; (2) penile bulb median dose; (3) rectum V80, V60, V50 and Dmax; and (4) urethra V120, V110, V100, and Dmax. | No patients registered to a dose escalation Phase I group were analyzed for this endpoint. With only 5 patients, the study team deemed that the information would be unsuitable. | Posted | From baseline to 5 years after registration |
|
| |||||||||||||||||||||||||||||
| Secondary | Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session) | Patient preference for second treatment (group 1 or group 2) will be assessed using a Treatment Preference Questionnaire (Appendix IX) developed specifically for this study. Qualitative and quantitative analyses will be performed on patient responses to the questions posed after choosing their second treatment in an exploratory fashion. | None of the enrolled patients were analyzed for this endpoint due to too few patients. | Posted | From baseline until the end of the first treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Changes in Health-related Quality of Life Scores | A pretest-posttest design will be employed to detect changes in HRQOL scores over time. The HRQOL scores will be calculated per assessment, as appropriate. Each construct will be standardized to a range of 0-100 so that comparison across constructs is facilitated. Sets of difference scores will be computed: 1) differences between baseline and treatment completion (at 1 month post treatment follow up), and 2) differences between treatment completion and all post-treatment follow-up examinations for up to five years after finishing the protocol treatment (see Section 4.1 for specific HRQOL instruments to be completed at follow-up visits). The first analysis will allow for determination of the short-term impact of treatment on HRQOL, while the second will investigate the long-term treatment effect. Student's t-test methodology will be applied to the differences at end of treatment (1 month post treatment follow up) and at each follow-up. | None of the enrolled patients were analyzed for this endpoint due to too few patients. | Posted | From baseline to 5 years after registration |
| ||||||||||||||||||||||||||||||
| Secondary | Freedom From Biochemical and Clinical Failure | Freedom from biochemical and clinical failure, will be analyzed using Kaplan-Meier procedures. Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from biochemical and clinical failure. | With only 5 patients, the study team deemed that the information would be unsuitable. | Posted | From baseline to 5 years after registration |
|
| |||||||||||||||||||||||||||||
| Secondary | Freedom From Salvage Androgen Suppression Treatment | Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from salvage androgen suppression therapy. | With only 5 patients, the study team deemed that this information would be unsuitable. | Posted | From baseline to 5 years after registration |
|
|
Adverse events were assessed within 7 days of High Dose-Rate Radiation (HDR) and External beam radiation therapy (EBRT), and at one month after completion of therapy, 6 months after registration, then every 6 months x 5 (through year 3), then every 12 months for years 4-5, then off study. Up to 5 years.
CTCAE term & grade: The descriptions & grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation & scientific analysis & is a single MedDRA Lowest Level Term (LLT). Only 1 patient was registered to the HDR+EBRT arm. Due to protected health information, listing only 1 patient's results is contraindicated.
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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 | Arm 1 (HDR ± EBRT) | Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session. | 0 | 5 | 0 | 5 | 5 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Bladder hemorrhage | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Bladder stenosis | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urethral hemorrhage | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 10 | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA 10 | Systematic Assessment |
| |
| Prostatic hemorrhage | Reproductive system and breast disorders | MedDRA 10 | Systematic Assessment |
| |
| Prostatic pain | Reproductive system and breast disorders | MedDRA 10 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas M. Pisansky, M.D. | Mayo Clinic | Pisansky.Thomas@mayo.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D061089 | Radiotherapy, Image-Guided |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
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| Units | Counts |
|---|---|
| Participants |
|