Trial Outcomes & Findings for Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer (NCT NCT00124917)

Last Updated: 2019-09-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

12 weeks after radiation therapy (RT)

Results posted on

2019-09-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.\[1\]
Overall Study STARTED	6
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.\[1\]
Overall Study Physician Decision	3

Baseline Characteristics

Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy - 7560 cGY n=6 Participants 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.\[1\]
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	68.17 years STANDARD_DEVIATION 10.07 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after radiation therapy (RT)

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 53 months and 20 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Radiation Therapy - 7560 cGY n=6 Participants 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.\[1\]
Number of Participants With Serious and Non-serious Adverse Events	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: completion of therapy

Population: This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Completion of therapy

Population: This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: completion of therapy

Population: This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects.

Acute and late toxicity will be assessed by the Radiation Therapy Oncology Group (RTOG) Acute and Late Toxicity Genitourinary (GI)/Gastrointestinal (GU) scales.

Outcome measures

Outcome data not reported

Adverse Events

Radiation Therapy - 7560 cGY

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Radiation Therapy - 7560 cGY n=6 participants at risk 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.\[1\]
Nervous system disorders Mood alteration:: Depression	16.7% 1/6 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Radiation Therapy - 7560 cGY n=6 participants at risk 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.\[1\]
Renal and urinary disorders Bladder spasms	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Constipation	33.3% 2/6 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • 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.
Reproductive system and breast disorders Ejaculatory dysfunction	16.7% 1/6 • Number of events 1 • 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.
General disorders Fatigue (asthenia, lethargy, malaise)	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Gastrointestinal - Other (Bloody stools)	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Gastrointestinal - Other (Hemorrhoids)	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Gastrointestinal - Other (Loose stools)	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Gastrointestinal - Other (Loose stools, urgency)	16.7% 1/6 • Number of events 1 • 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.
Blood and lymphatic system disorders Hemoglobin	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Hemorrhage, GI - Rectum	16.7% 1/6 • Number of events 1 • 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.
Endocrine disorders Hot flashes/flushes	16.7% 1/6 • Number of events 2 • 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.
Renal and urinary disorders Incontinence, urinary	16.7% 1/6 • Number of events 2 • 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.
Reproductive system and breast disorders Libido	33.3% 2/6 • Number of events 2 • 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.
Nervous system disorders Mood alteration::Depression	33.3% 2/6 • Number of events 2 • 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.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Pain - Other (Generalized body)	16.7% 1/6 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Pain - Other (Lower back)	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Pain::Abdomen NOS	16.7% 1/6 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pain::Chest/thorax NOS	16.7% 1/6 • Number of events 1 • 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.
Reproductive system and breast disorders Pain::Penis	16.7% 1/6 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Rash/desquamation	16.7% 1/6 • Number of events 1 • 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.
Renal and urinary disorders Renal/Genitourinary - Other, Dysuria	50.0% 3/6 • Number of events 5 • 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.
Renal and urinary disorders Renal/Genitourinary - Other, Weak stream	33.3% 2/6 • Number of events 4 • 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.
Renal and urinary disorders Urinary frequency/urgency	33.3% 2/6 • Number of events 5 • 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.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	16.7% 1/6 • Number of events 2 • 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.
General disorders Weight gain	50.0% 3/6 • Number of events 4 • 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.
General disorders Weight loss	16.7% 1/6 • Number of events 1 • 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.
Reproductive system and breast disorders Erectile dysfunction	50.0% 3/6 • Number of events 3 • 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.

Additional Information

Dr. Deborah Citrin

National Cancer Institute

Phone: 301-496-5457

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place