| ID | Type | Description | Link |
|---|---|---|---|
| 05-C-0191 |
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Study closed due to unanticipated toxicity/risks to subjects.
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BACKGROUND:
-This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain magnetic resonance (MR) biological images and co-register tissue in prostate cancer patients.
OBJECTIVES:
-The scientific objective of this protocol is to determine the maximum tolerated dose (MTD) of external beam radiation to regions of interest within the prostate based acute toxicity.
Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity.
ELIGIBILITY:
-Patients with prostate cancer without evidence of metastasis will be eligible for this study.
DESIGN:
BACKGROUND:
-This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (RO)B protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain magnetic resonance (MR) biological images and co-register tissue in prostate cancer patients.
OBJECTIVES:
ELIGIBILITY:
-Patients with prostate cancer without evidence of metastasis will be eligible for this study.
DESIGN:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy | Experimental | Radiation to tumor area as per protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.[1] |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of External Beam Radiation | Maximum tolerated dose is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experienced a dose limiting toxicity attributed to radiation therapy. | 12 weeks after radiation therapy (RT) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and Non-serious Adverse Events | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTC v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Response With Genomic and Proteomic Analyses | Genomic and proteomic analyses will be conducted on a gene by gene basis using a 2-sample t-test at the 0.001 level and correlated with radiation response. | completion of therapy |
| Correlate Toxicity With Genomic and Proteomic Analyses |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Cognitively impaired patients who cannot give informed consent.
Patients with metastatic disease.
Contraindication to biopsy
Contraindication to magnetic resonance imaging (MRI)
Pre-existing and active prostatitis or proctitis
Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Aradhana Kaushal, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14967428 | Background | Michalski JM, Winter K, Purdy JA, Perez CA, Ryu JK, Parliament MB, Valicenti RK, Roach M 3rd, Sandler HM, Markoe AM, Cox JD. Toxicity after three-dimensional radiotherapy for prostate cancer with RTOG 9406 dose level IV. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):735-42. doi: 10.1016/S0360-3016(03)01578-5. | |
| 12128107 | Background |
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All 6 participants enrolled in this trial received a dose of 7560 cGy and are grouped together in one Arm/Group. An attempt was made to escalate to the next higher dose but we were unable to treat patients and maintain safety standards.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy - 7560 cGY | Radiation to tumor area as per protocol Radiation: Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.[1] |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All 6 participants enrolled in this trial received a dose of 7560 cGy and are grouped together in one Arm/Group. An attempt was made to escalate to the next higher dose but we were unable to treat patients and maintain safety standards.
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy - 7560 cGY | Radiation to tumor area as per protocol Radiation: Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.[1] |
| 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 | Maximum Tolerated Dose (MTD) of External Beam Radiation | Maximum tolerated dose is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experienced a dose limiting toxicity attributed to radiation therapy. | This outcome measure was not done. All 6 participants enrolled in this trial received a dose of 7560 cGy and are grouped together in one Arm/Group. An attempt was made to escalate to the next higher dose but we were unable to treat patients and maintain safety standards. | Posted | 12 weeks after radiation therapy (RT) |
|
53 months and 20 days
All 6 participants enrolled in this trial received a dose of 7560 cGy and are grouped together in one Arm/Group. An attempt was made to escalate to the next higher dose but we were unable to treat patients and maintain safety standards.
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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 - 7560 cGY | Radiation to tumor area as per protocol Radiation: Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.[1] |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mood alteration:: Depression | Nervous system disorders | CTC (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder spasms | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deborah Citrin | National Cancer Institute | 301-496-5457 | Debra_Citrin@nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2015 | Aug 1, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 13, 2009 | Aug 1, 2019 | ICF_001.pdf |
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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 |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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|
| 53 months and 20 days |
Genomic and proteomic analyses will be conducted on a gene by gene basis using a 2-sample t-test at the 0.001 level and correlated with toxicity. |
| Completion of therapy |
| Long-term Effects and Toxicity Following Selective Intra-prostatic Dose Escalation | Acute and late toxicity will be assessed by the Radiation Therapy Oncology Group (RTOG) Acute and Late Toxicity Genitourinary (GI)/Gastrointestinal (GU) scales. | completion of therapy |
| Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8. |
| 12961097 | Background | Pollack A, Hanlon A, Horwitz EM, Feigenberg S, Uzzo RG, Price RA. Radiation therapy dose escalation for prostate cancer: a rationale for IMRT. World J Urol. 2003 Sep;21(4):200-8. doi: 10.1007/s00345-003-0356-x. Epub 2003 Sep 5. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
|
| Secondary | Number of Participants With Serious and Non-serious Adverse Events | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTC v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | All 6 participants enrolled in this trial received a dose of 7560 cGy and are grouped together in one Arm/Group. An attempt was made to escalate to the next higher dose but we were unable to treat patients and maintain safety standards. | Posted | Count of Participants | Participants | 53 months and 20 days |
|
|
|
| Other Pre-specified | Radiation Response With Genomic and Proteomic Analyses | Genomic and proteomic analyses will be conducted on a gene by gene basis using a 2-sample t-test at the 0.001 level and correlated with radiation response. | This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects. | Posted | completion of therapy |
|
|
| Other Pre-specified | Correlate Toxicity With Genomic and Proteomic Analyses | Genomic and proteomic analyses will be conducted on a gene by gene basis using a 2-sample t-test at the 0.001 level and correlated with toxicity. | This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects. | Posted | Completion of therapy |
|
|
| Other Pre-specified | Long-term Effects and Toxicity Following Selective Intra-prostatic Dose Escalation | Acute and late toxicity will be assessed by the Radiation Therapy Oncology Group (RTOG) Acute and Late Toxicity Genitourinary (GI)/Gastrointestinal (GU) scales. | This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects. | Posted | completion of therapy |
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| 3 |
| 6 |
| Constipation | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTC (3.0) | Systematic Assessment |
|
| Ejaculatory dysfunction | Reproductive system and breast disorders | CTC (3.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (Bloody stools) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (Hemorrhoids) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (Loose stools) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Gastrointestinal - Other (Loose stools, urgency) | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC (3.0) | Systematic Assessment |
|
| Hemorrhage, GI - Rectum | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Hot flashes/flushes | Endocrine disorders | CTC (3.0) | Systematic Assessment |
|
| Incontinence, urinary | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Libido | Reproductive system and breast disorders | CTC (3.0) | Systematic Assessment |
|
| Mood alteration::Depression | Nervous system disorders | CTC (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Pain - Other (Generalized body) | Musculoskeletal and connective tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Pain - Other (Lower back) | Musculoskeletal and connective tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Pain::Abdomen NOS | Gastrointestinal disorders | CTC (3.0) | Systematic Assessment |
|
| Pain::Chest/thorax NOS | Respiratory, thoracic and mediastinal disorders | CTC (3.0) | Systematic Assessment |
|
| Pain::Penis | Reproductive system and breast disorders | CTC (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC (3.0) | Systematic Assessment |
|
| Renal/Genitourinary - Other, Dysuria | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Renal/Genitourinary - Other, Weak stream | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTC (3.0) | Systematic Assessment |
|
| Weight gain | General disorders | CTC (3.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTC (3.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTC (3.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |