A Phase 2 interventional study of 68Ga-HBED-CC-PSMA in Prostate Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.
PSMA-PET is highly sensitive and specific for detecting prostate cancer. PSMA-PET and mpMRI can potentially help guide target volumes for patients with unfavorable-risk prostate cancer receiving radiation by designing a radiation treatment plan so that the entire prostate receives the prescribed dose of radiation in addition to the visible tumor in the prostate as detected by mpMRI and/or PSMA-PET receiving any inevitable intrinsic plan "hot spots" or areas of dose above the prescription.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 8 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other prior or concomitant malignancies with the exception of:
Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment
Drug: 68Ga-HBED-CC-PSMA
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.
Also known as: gallium Ga 68-labeled PSMA-11
Early Genitourinary and Gastrointestinal Toxicity
Grade 3 or higher early genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop within three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time frame: Up to 22 weeks (3 months after completion of radiation therapy)
Late Genitourinary Toxicity After Radiation
Grade 3 or higher late genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequence
Time frame: Three months after starting radiation therapy to up to 48 months post-treatment
Biochemical Control Using Prostate-Specific Antigen (PSA) Levels
Biochemical control will be defined according to the Phoenix criteria (PSA rise of \<2 ng/mL over nadir). Number of subjects
Time frame: At 2 years after radiation therapy
Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) Rectal Domain
Patient-reported quality of life in men with prostate cancer can be assessed using the Prostate Cancer Symptom Indices (PCSI), a validated instrument designed to measure disease-specific symptoms and their impact on daily functioning. The PCSI evaluates multiple domains, including urinary function, bowel function, sexual function, and overall well-being. Each domain contains a set of symptom-specific questions rated on a Likert-type scale, typically ranging from 0 (no symptoms or no problem) to 4 or 5 (severe symptoms or major problem). Domain scores were calculated by summing item responses and converting them to a 0-100 scale, where higher scores indicate greater symptom burden.
Time frame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy
Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) - Urinary Domain
Patient-reported quality of life in men with prostate cancer can be assessed using the Prostate Cancer Symptom Indices (PCSI), a validated instrument designed to measure disease-specific symptoms and their impact on daily functioning. The PCSI evaluates multiple domains, including urinary function, bowel function, sexual function, and overall well-being. Each domain contains a set of symptom-specific questions rated on a Likert-type scale, typically ranging from 0 (no symptoms or no problem) to 4 or 5 (severe symptoms or major problem). Domain scores were calculated by summing item responses and converting them to a 0-100 scale, where higher scores indicate greater symptom burden.
Time frame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Bowel Domain
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 bowel domain reflects symptoms such as bowel urgency, frequency, pain, and overall bowel function. Patients rate each item on a 1-5 scale, and responses are converted to a 0-100 score, with higher scores indicating better bowel function and fewer symptoms. This domain provides a focused measure of how prostate cancer and its treatments affect daily bowel-related quality of life.
Time frame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Hormonal Function Domain
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 hormonal function domain captures symptoms such as fatigue, hot flashes, breast tenderness, and emotional changes. Items are rated on a 1-5 scale and converted to a 0-100 score, with higher scores indicating better hormonal function and fewer symptoms. This domain provides a focused assessment of how prostate cancer and its treatments affect patients' hormone-related quality of life.
Time frame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) -Sexual Function Domain
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 sexual function domain assesses erectile function, ability to achieve orgasm, sexual desire, and overall sexual satisfaction. Items are rated on a 1-5 scale and converted to a 0-100 score, with higher scores reflecting better sexual function and fewer difficulties. This domain provides a focused measure of how prostate cancer and its treatments impact sexual health and related quality of life.
Time frame: Baseline and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Urinary Incontinence, Urinary Irritation Domains
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 urinary incontinence and urinary irritation/obstruction domains reflects issues such as urine leakage, pad use, urgency, frequency, and weak stream. Items are rated on a 1-5 scale and converted to 0-100 scores, with higher values indicating better urinary function and fewer symptoms. Together, these domains provide a detailed view of how prostate cancer and its treatments affect daily urinary health.
Time frame: at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy
The Number of Participants Started Study.
The number of participants started study.
Time frame: Baseline
| Milestone | PMSA-PET/MRI |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
Grade 3 or higher early genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop within three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
| Participants | PMSA-PET/MRI |
|---|---|
| Early Genitourinary and Gastrointestinal Toxicity | 0 |
Grade 3 or higher late genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequence
| Participants | PMSA-PET/MRI |
|---|---|
| Proctitis (gastrointestinal toxicity) | 1 |
| Rectal fistula (gastrointestinal toxicity) | 1 |
| Rectal ulcer (gastrointestinal toxicity) | 1 |
| Fecal incontinence | 1 |
| Kidney infection (Pyelonephritis) | 1 |
Biochemical control will be defined according to the Phoenix criteria (PSA rise of \<2 ng/mL over nadir). Number of subjects
| Participants | PMSA-PET/MRI |
|---|---|
| Biochemical control achieved | 4 |
| Biochemical control not achieved | 0 |
Patient-reported quality of life in men with prostate cancer can be assessed using the Prostate Cancer Symptom Indices (PCSI), a validated instrument designed to measure disease-specific symptoms and their impact on daily functioning. The PCSI evaluates multiple domains, including urinary function, bowel function, sexual function, and overall well-being. Each domain contains a set of symptom-specific questions rated on a Likert-type scale, typically ranging from 0 (no symptoms or no problem) to 4 or 5 (severe symptoms or major problem). Domain scores were calculated by summing item responses and converting them to a 0-100 scale, where higher scores indicate greater symptom burden.
| score on a scale | 1 Month | 3 Months | 6 Months | 9 Months | 12 Months | 18 Months | 24 Months | 30 Months | 36 Months | 42 Months |
|---|---|---|---|---|---|---|---|---|---|---|
| Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) Rectal Domain | 98.2 ± 2.5 | 96.4 ± 0 | 94 ± 5.5 | 83.9 ± 7.6 | 71.4 ± 15.2 | 96.4 ± 5.1 | 89.3 ± 15.2 | 95.2 ± 8.2 | 100 ± 0 | 100 ± NA |
Patient-reported quality of life in men with prostate cancer can be assessed using the Prostate Cancer Symptom Indices (PCSI), a validated instrument designed to measure disease-specific symptoms and their impact on daily functioning. The PCSI evaluates multiple domains, including urinary function, bowel function, sexual function, and overall well-being. Each domain contains a set of symptom-specific questions rated on a Likert-type scale, typically ranging from 0 (no symptoms or no problem) to 4 or 5 (severe symptoms or major problem). Domain scores were calculated by summing item responses and converting them to a 0-100 scale, where higher scores indicate greater symptom burden.
| score on a scale | 1 Month | 3 Months | 6 Months | 9 Months | 12 Months | 18 Months | 24 Months | 30 Months | 36 Months | 42 Months |
|---|---|---|---|---|---|---|---|---|---|---|
| Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) - Urinary Domain | 63.1 ± 28.7 | 64.4 ± 8.4 | 68.7 ± 15.3 | 51.8 ± 26.2 | 22.6 ± 6.8 | 53.6 ± 3.3 | 69.7 ± 7.7 | 92.9 ± 9.4 | 78.7 ± NA | 100 ± NA |
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 bowel domain reflects symptoms such as bowel urgency, frequency, pain, and overall bowel function. Patients rate each item on a 1-5 scale, and responses are converted to a 0-100 score, with higher scores indicating better bowel function and fewer symptoms. This domain provides a focused measure of how prostate cancer and its treatments affect daily bowel-related quality of life.
| score on a scale | 1 Month | 3 Months | 6 Months | 9 Months | 12 Months | 18 Months | 24 Months | 30 Months | 36 Months | 42 Months |
|---|---|---|---|---|---|---|---|---|---|---|
| Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Bowel Domain | 98.6 ± 2.4 | 95.8 ± 0 | 86.1 ± 14.6 | 77.8 ± 21 | 93.8 ± 2.9 | 87.5 ± NA | 100 ± 0 | 88.9 ± 19.2 | 100 ± 0 | 100 ± NA |
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 hormonal function domain captures symptoms such as fatigue, hot flashes, breast tenderness, and emotional changes. Items are rated on a 1-5 scale and converted to a 0-100 score, with higher scores indicating better hormonal function and fewer symptoms. This domain provides a focused assessment of how prostate cancer and its treatments affect patients' hormone-related quality of life.
| score on a scale | 1 Month | 3 Months | 6 Months | 9 Months | 12 Months | 18 Months | 24 Months | 30 Months | 36 Months | 42 Months |
|---|---|---|---|---|---|---|---|---|---|---|
| Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Hormonal Function Domain | 70 ± 28.3 | 57.5 ± 3.5 | 88.3 ± 11.5 | 83.3 ± 16.1 | 95 ± 7.1 | 62.5 ± NA | 80 ± 28.3 | 100 ± 0 | 100 ± NA | 100 ± NA |
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 sexual function domain assesses erectile function, ability to achieve orgasm, sexual desire, and overall sexual satisfaction. Items are rated on a 1-5 scale and converted to a 0-100 score, with higher scores reflecting better sexual function and fewer difficulties. This domain provides a focused measure of how prostate cancer and its treatments impact sexual health and related quality of life.
| score on a scale | 1 Month | 3 Months | 6 Months | 9 Months | 12 Months | 18 Months | 24 Months | 30 Months | 36 Months | 42 Months |
|---|---|---|---|---|---|---|---|---|---|---|
| Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) -Sexual Function Domain | 43 ± NA | 31.2 ± 20.6 | 12.2 ± 10.7 | 8.3 ± 8.3 | 25.8 ± 13 | 12.5 ± NA | 36.8 ± 46.2 | 44 ± 38.9 | 40.3 ± NA | 69.5 ± NA |
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 urinary incontinence and urinary irritation/obstruction domains reflects issues such as urine leakage, pad use, urgency, frequency, and weak stream. Items are rated on a 1-5 scale and converted to 0-100 scores, with higher values indicating better urinary function and fewer symptoms. Together, these domains provide a detailed view of how prostate cancer and its treatments affect daily urinary health.
| score on a scale | 1 Month | 3 Months | 6 Months | 9 Months | 12 Months | 18 Months | 24 Months | 30 Months | 36 Months | 42 Months |
|---|---|---|---|---|---|---|---|---|---|---|
| Urinary incontinence | 84.8 ± 13.4 | 76 ± 33.9 | 82 ± 13.4 | 63.2 ± 33.9 | 66.6 ± 38.4 | 79.2 ± NA | 67.8 ± 25.1 | 79.2 ± 36.1 | 92.8 ± 10.3 | 50 ± 0 |
| urinary irritation | 62.5 ± 21.7 | 53.1 ± 13.3 | 89.6 ± 13 | 77.1 ± 29.5 | 43.8 ± 17.7 | 68.8 ± NA | 81.2 ± 8.8 | 100 ± 0 | 100 ± 0 | 100 ± 0 |
The number of participants started study.
| Participants | PMSA-PET/MRI |
|---|---|
| The Number of Participants Started Study. | 8 |
Collected over Up to 49 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PMSA-PET/MRI | 2/8 (25%) | 2/8 (25%) | 8/8 (100%) |
| Event | PMSA-PET/MRI |
|---|---|
| ProctitisGastrointestinal disorders | 1/8 |
| Rectal ulcerGastrointestinal disorders | 1/8 |
| Rectal fistulaGastrointestinal disorders | 1/8 |
| Kidney infectionInfections and infestations | 1/8 |
| AcidosisMetabolism and nutrition disorders | 1/8 |
| HyperglycemiaMetabolism and nutrition disorders | 1/8 |
| Event | PMSA-PET/MRI |
|---|---|
| Urinary frequencyRenal and urinary disorders | 7/8 |
| Hot flashesVascular disorders | 6/8 |
| FatigueGeneral disorders | 3/8 |
| ProctitisGastrointestinal disorders | 2/8 |
| DysuriaRenal and urinary disorders | 2/8 |
| Urinary retentionRenal and urinary disorders | 2/8 |
| Urinary incontinenceRenal and urinary disorders | 2/8 |
| ConstipationGastrointestinal disorders | 1/8 |
| DiarrheaGastrointestinal disorders | 1/8 |
| Rectal painGastrointestinal disorders | 1/8 |
All participants who started to study treatment were included.
| Age, Continuous(years) | PMSA-PET/MRI |
|---|---|
| Mean | 67.38 (59 to 77) |
| Sex: Female, Male(Participants) | PMSA-PET/MRI |
|---|---|
| Female | 0 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | PMSA-PET/MRI |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | PMSA-PET/MRI |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | PMSA-PET/MRI |
|---|---|
| United States | 8 |
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UNC Lineberger Comprehensive Cancer Center