Prostate CancerPhase 2NCT04176497
PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
A Phase 2 study testing 68Ga-HBED-CC-PSMA in people with Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 68Ga-HBED-CC-PSMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 25 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Histologically confirmed prostate adenocarcinoma
- Unfavorable intermediate or high-risk, based on the National Comprehensive Cancer Network (NCCN) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol.
- Subject has adequate performance status as defined by ECOG performance status of 0-2.
- Subject is willing and able to comply with the protocol as determined by the Treating Investigator.
- Subject speaks English (quality of life instrument is validated in English).
Who cannot join
- Contraindications for MRI
- Other prior or concomitant malignancies with the exception of:
- Non-melanoma skin cancer
- Other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence.
- Inflammatory bowel disease
- Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-HBED-CC-PSMA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-HBED-CC-PSMADrug
Also called gallium Ga 68-labeled PSMA-11
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| PMSA-PET/MRI | Experimental | Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment Receives: Drug: 68Ga-HBED-CC-PSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 22 weeks (3 months after completion of radiation therapy)
Secondary outcomes (9)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start16 Jul 2020
- Primary completion7 Feb 2024
- Study completion25 Oct 2024
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Repka, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176497
- Sponsor's protocol ID
- LCCC1908
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2019
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation
- ClinicalTrials.gov ID
- NCT04176497
- Acronym / sponsor ID
- LCCC1908
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 8 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Posted 28 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PMSA-PET/MRI | Experimental | Drug: 68Ga-HBED-CC-PSMAPatients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Histologically confirmed prostate adenocarcinoma
- Unfavorable intermediate or high-risk, based on the National Comprehensive Cancer Network (NCCN) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol.
- Subject has adequate performance status as defined by ECOG performance status of 0-2.
- Subject is willing and able to comply with the protocol as determined by the Treating Investigator.
Key exclusion criteria (6 listed)
- Contraindications for MRI
- Other prior or concomitant malignancies with the exception of:
- Inflammatory bowel disease
- Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-HBED-CC-PSMAAlso: gallium Ga 68-labeled PSMA-11Radioactive tracer used during imaging to help detect PSMA expressing tumor cells. | Drug | PMSA-PET/MRI |
Primary outcome
Early Genitourinary and Gastrointestinal Toxicity
Time frame: Up to 22 weeks (3 months after completion of radiation therapy)
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.
9 secondary outcomes
Late Genitourinary Toxicity After Radiation
Time frame: Three months after starting radiation therapy to up to 48 months post-treatment
Biochemical Control Using Prostate-Specific Antigen (PSA) Levels
Time frame: At 2 years after radiation therapy
Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) Rectal Domain
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
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
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
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
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
Time frame: at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy
The Number of Participants Started Study.
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Repka, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-HBED-CC-PSMA in people with Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Genitourinary and Gastrointestinal Toxicity (time frame: Up to 22 weeks (3 months after completion of radiation therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.