Prostate CancerPhase 2NCT04243941
PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer
A Phase 2 study testing 68Ga-HBED-CC-PSMA in people with Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center.
Trial summary
The goal of this study is to determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant… 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2022to 7 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male subjects ≥ 18 years of age
- Histologically confirmed prostate adenocarcinoma
- Low or favorable intermediate risk, based on the NCCN criteria
- 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
- Previous transurethral resection of the prostate (TURP) or surgery of the prostate
About this study
Official title: LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy
The goal of this study is to determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all current planning criteria.
Read the detailed description
This study aims to determine if multi-parametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging can help optimize the placement of the high dose inhomogeneity characterizing stereotactic body radiation therapy. All radiation plans have "hot spots" of radiation, and in current practice these regions are randomly located. This study will focus those hot spots on regions determined by mpMRI + PSMA-PET to have visible tumor.
- 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.
Genitourinary and gastrointestinal toxicity 12 months post-treatment
Grade 2+ GU/GI late toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 at 12 months after radiation therapy
Measured: Baseline to 1 year post-treatment
Feasibility of meeting specified dose constraints
Proportion of subjects who meet these criteria:
- Boost dose coverage: DIL D95% ≥ 44 Gy
- Dose constraints:
Urethra Dmax < 40 Gy
Bladder Dmax < 45.6 Gy
Bladder D10cc < 41.8 Gy
Rectum Dmax < 38 Gy
Rectal Mucosa D1% < 28.5 Gy
Sigmoid Colon Dmax < 28.5 Gy
Measured: Baseline to 1 year post-treatment
Secondary outcomes (5)
Acute and late genitourinary and gastrointestinal toxicity
GU and GI toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Will be measured during radiation therapy and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after radiotherapy.
Measured: Baseline to 5 years post-treatment
Biochemical control using Prostate-Specific Antigen (PSA) levels
Biochemical control will be defined according to the Phoenix criteria at 2 and 5 years after radiation therapy
Measured: Baseline to 5 years post-treatment
Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26)
Measuring patient-reported quality of life using EPIC-26 prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy targets.
Measured: Baseline to 5 years post-treatment
Screened Subjects
Measuring the proportion of screened subjects who are enrolled on the study
Measured: Through study completion, average of 2 years
Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI)
Measuring patient-reported quality of life using PCSI prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy targets.
Measured: Baseline to 5 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start29 Nov 2022
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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
- NCT04243941
- Sponsor's protocol ID
- LCCC1917
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy
- ClinicalTrials.gov ID
- NCT04243941
- Acronym / sponsor ID
- LCCC1917
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
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 determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all current planning criteria.
Detailed description
This study aims to determine if multi-parametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging can help optimize the placement of the high dose inhomogeneity characterizing stereotactic body radiation therapy. All radiation plans have "hot spots" of radiation, and in current practice these regions are randomly located. This study will focus those hot spots on regions determined by mpMRI + PSMA-PET to have visible tumor.
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 (7 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
- Male subjects ≥ 18 years of age
- Histologically confirmed prostate adenocarcinoma
- Low or favorable intermediate risk, based on the NCCN criteria
- Subject has adequate performance status as defined by ECOG performance status of 0-2
Key exclusion criteria (6 listed)
- 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
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
Genitourinary and gastrointestinal toxicity 12 months post-treatment
Time frame: Baseline to 1 year post-treatment
Grade 2+ GU/GI late toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 at 12 months after radiation therapy
Feasibility of meeting specified dose constraints
Time frame: Baseline to 1 year post-treatment
Proportion of subjects who meet these criteria: * Boost dose coverage: DIL D95% ≥ 44 Gy * Dose constraints: Urethra Dmax < 40 Gy Bladder Dmax < 45.6 Gy Bladder D10cc < 41.8 Gy Rectum Dmax < 38 Gy Rectal Mucosa D1% < 28.5 Gy Sigmoid Colon Dmax < 28.5 Gy
5 secondary outcomes
Acute and late genitourinary and gastrointestinal toxicity
Time frame: Baseline to 5 years post-treatment
Biochemical control using Prostate-Specific Antigen (PSA) levels
Time frame: Baseline to 5 years post-treatment
Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26)
Time frame: Baseline to 5 years post-treatment
Screened Subjects
Time frame: Through study completion, average of 2 years
Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI)
Time frame: Baseline to 5 years post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink 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
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.
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 7 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: withdrawn, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Genitourinary and gastrointestinal toxicity 12 months post-treatment (time frame: Baseline to 1 year post-treatment). The study lists 2 primary outcomes in all. 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 21 Mar 2024.