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Trial record 8 of 1440 for:    prostate cancer AND radiation

Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00124917
Recruitment Status : Terminated (Study closed due to unanticipated toxicity/risks to subjects.)
First Posted : July 28, 2005
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Deborah Citrin, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Radiation: Radiation
Enrollment 6
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Radiation Therapy - 7560 cGY
Hide Arm/Group Description

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]

Period Title: Overall Study
Started 6
Completed 3
Not Completed 3
Reason Not Completed
Physician Decision             3
Arm/Group Title Radiation Therapy - 7560 cGY
Hide Arm/Group Description

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]

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  33.3%
>=65 years
4
  66.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
68.17  (10.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
0
   0.0%
Male
6
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
6
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of External Beam Radiation
Hide Description 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.
Time Frame 12 weeks after radiation therapy (RT)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Radiation Therapy - 7560 cGY
Hide Arm/Group Description:

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]

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events
Hide Description 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.
Time Frame 53 months and 20 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Radiation Therapy - 7560 cGY
Hide Arm/Group Description:

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]

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
3
  50.0%
3.Other Pre-specified Outcome
Title Radiation Response With Genomic and Proteomic Analyses
Hide Description 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.
Time Frame completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects.
Arm/Group Title Radiation Therapy - 7560 cGY
Hide Arm/Group Description:

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]

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Other Pre-specified Outcome
Title Correlate Toxicity With Genomic and Proteomic Analyses
Hide Description 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.
Time Frame Completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects.
Arm/Group Title Radiation Therapy - 7560 cGY
Hide Arm/Group Description:

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 centigray (cGy) daily fractions.[1]

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Long-term Effects and Toxicity Following Selective Intra-prostatic Dose Escalation
Hide Description Acute and late toxicity will be assessed by the Radiation Therapy Oncology Group (RTOG) Acute and Late Toxicity Genitourinary (GI)/Gastrointestinal (GU) scales.
Time Frame completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects.
Arm/Group Title Radiation Therapy - 7560 cGY
Hide Arm/Group Description:

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]

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 53 months and 20 days
Adverse Event Reporting Description 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.
 
Arm/Group Title Radiation Therapy - 7560 cGY
Hide Arm/Group Description

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]

All-Cause Mortality
Radiation Therapy - 7560 cGY
Affected / at Risk (%)
Total   0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Radiation Therapy - 7560 cGY
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Nervous system disorders   
Mood alteration:: Depression  1  1/6 (16.67%)  1
1
Term from vocabulary, CTC (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiation Therapy - 7560 cGY
Affected / at Risk (%) # Events
Total   3/6 (50.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  1/6 (16.67%)  1
Endocrine disorders   
Hot flashes/flushes  1  1/6 (16.67%)  2
Gastrointestinal disorders   
Constipation  1  2/6 (33.33%)  2
Gastrointestinal - Other (Bloody stools)  1  1/6 (16.67%)  1
Gastrointestinal - Other (Hemorrhoids)  1  1/6 (16.67%)  1
Gastrointestinal - Other (Loose stools)  1  1/6 (16.67%)  1
Gastrointestinal - Other (Loose stools, urgency)  1  1/6 (16.67%)  1
Hemorrhage, GI - Rectum  1  1/6 (16.67%)  1
Nausea  1  1/6 (16.67%)  1
Pain::Abdomen NOS  1  1/6 (16.67%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  1/6 (16.67%)  1
Weight gain  1  3/6 (50.00%)  4
Weight loss  1  1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders   
Pain - Other (Generalized body)  1  1/6 (16.67%)  1
Pain - Other (Lower back)  1  1/6 (16.67%)  1
Nervous system disorders   
Mood alteration::Depression  1  2/6 (33.33%)  2
Renal and urinary disorders   
Bladder spasms  1  1/6 (16.67%)  1
Incontinence, urinary  1  1/6 (16.67%)  2
Renal/Genitourinary - Other, Dysuria  1  3/6 (50.00%)  5
Renal/Genitourinary - Other, Weak stream  1  2/6 (33.33%)  4
Urinary frequency/urgency  1  2/6 (33.33%)  5
Urinary retention (including neurogenic bladder)  1  1/6 (16.67%)  2
Reproductive system and breast disorders   
Ejaculatory dysfunction  1  1/6 (16.67%)  1
Libido  1  2/6 (33.33%)  2
Pain::Penis  1  1/6 (16.67%)  1
Erectile dysfunction  1  3/6 (50.00%)  3
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/6 (16.67%)  1
Pain::Chest/thorax NOS  1  1/6 (16.67%)  1
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  1/6 (16.67%)  1
1
Term from vocabulary, CTC (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Deborah Citrin
Organization: National Cancer Institute
Phone: 301-496-5457
EMail: Debra_Citrin@nih.gov
Layout table for additonal information
Responsible Party: Deborah Citrin, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00124917     History of Changes
Obsolete Identifiers: NCT00227799
Other Study ID Numbers: 050191
05-C-0191
First Submitted: July 27, 2005
First Posted: July 28, 2005
Results First Submitted: August 14, 2019
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019