A Phase 1 interventional study of Radiation in Prostate Cancer, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-09-13.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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:
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 6 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
EXCLUSION CRITERIA:
Contraindication to biopsy
Contraindication to magnetic resonance imaging (MRI)
Radiation to tumor area as per protocol
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.\[1\]
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.
Time frame: 12 weeks after radiation therapy (RT)
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.
Time frame: 53 months and 20 days
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.
Time frame: completion of therapy
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.
Time frame: 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.
Time frame: completion of therapy
| Milestone | Radiation Therapy - 7560 cGY |
|---|---|
| Started | 6 |
| Completed | 3 |
| Not completed | 3 |
| Withdrew: Physician decision | 3 |
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.
No measurements were reported for this outcome.
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.
| Participants | Radiation Therapy - 7560 cGY |
|---|---|
| Number of Participants With Serious and Non-serious Adverse Events | 3 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Acute and late toxicity will be assessed by the Radiation Therapy Oncology Group (RTOG) Acute and Late Toxicity Genitourinary (GI)/Gastrointestinal (GU) scales.
No measurements were reported for this outcome.
Collected over 53 months and 20 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiation Therapy - 7560 cGY | 0/6 (0%) | 1/6 (16.7%) | 3/6 (50%) |
| Event | Radiation Therapy - 7560 cGY |
|---|---|
| Mood alteration:: DepressionNervous system disorders | 1/6 |
| Event | Radiation Therapy - 7560 cGY |
|---|---|
| Renal/Genitourinary - Other, DysuriaRenal and urinary disorders | 3/6 |
| Weight gainGeneral disorders | 3/6 |
| Erectile dysfunctionReproductive system and breast disorders | 3/6 |
| ConstipationGastrointestinal disorders | 2/6 |
| LibidoReproductive system and breast disorders | 2/6 |
| Mood alteration::DepressionNervous system disorders | 2/6 |
| Renal/Genitourinary - Other, Weak streamRenal and urinary disorders | 2/6 |
| Urinary frequency/urgencyRenal and urinary disorders | 2/6 |
| Bladder spasmsRenal and urinary disorders | 1/6 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/6 |
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(Participants) | Radiation Therapy - 7560 cGY |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 4 |
| Age, Continuous(years) | Radiation Therapy - 7560 cGY |
|---|---|
| Mean | 68.17 ± 10.07 |
| Sex: Female, Male(Participants) | Radiation Therapy - 7560 cGY |
|---|---|
| Female | 0 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Radiation Therapy - 7560 cGY |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Radiation Therapy - 7560 cGY |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Radiation Therapy - 7560 cGY |
|---|---|
| United States | 6 |
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National Cancer Institute (NCI)