PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study

Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04176497

Enrollment

Registered

2019-11-25

Start date

2020-07-16

Completion date

2024-10-25

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief 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.

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.

Interventions

DRUG68Ga-HBED-CC-PSMA

Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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).

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Early Genitourinary and Gastrointestinal Toxicity	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.

Secondary

Measure	Time frame	Description
Biochemical Control Using Prostate-Specific Antigen (PSA) Levels	At 2 years after radiation therapy	Biochemical control will be defined according to the Phoenix criteria (PSA rise of \<2 ng/mL over nadir). Number of subjects
The Number of Participants Started Study.	Baseline	The number of participants started study.
Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) Rectal Domain	At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy	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.
Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) - Urinary Domain	At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy	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.
Late Genitourinary Toxicity After Radiation	Three months after starting radiation therapy to up to 48 months post-treatment	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
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Hormonal Function Domain	At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy	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.
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) -Sexual Function Domain	Baseline and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy	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.
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Urinary Incontinence, Urinary Irritation Domains	at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy	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.
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Bowel Domain	At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy	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.

Countries

United States

Participant flow

Pre-assignment details

Eight subjects were screened, enrolled, and started treatment at one center in the United States between 7/16/2020 and 2/7/2024.

Participants by arm

Arm	Count
PMSA-PET/MRI Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment 68Ga-HBED-CC-PSMA: Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.	8
Total	8

Baseline characteristics

Characteristic	PMSA-PET/MRI
Age, Continuous	67.38 years
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	4 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	4 Participants
Region of Enrollment United States	8 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	2 / 8
other Total, other adverse events	8 / 8
serious Total, serious adverse events	2 / 8

Outcome results

Primary

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)

Population: Participants started study treatment

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
PMSA-PET/MRI	Early Genitourinary and Gastrointestinal Toxicity	0 Participants

Secondary

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

Population: We have data available for only 4 subjects at 2 years because of subjects withdrawn, and we do not have 5 years follow-up data for any subjects due to study was terminated by sponsor.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
PMSA-PET/MRI	Biochemical Control Using Prostate-Specific Antigen (PSA) Levels	Biochemical control not achieved	0 Participants
PMSA-PET/MRI	Biochemical Control Using Prostate-Specific Antigen (PSA) Levels	Biochemical control achieved	4 Participants

Secondary

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

Population: Participants who started study treatment

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
PMSA-PET/MRI	Late Genitourinary Toxicity After Radiation	Proctitis (gastrointestinal toxicity)	1 Participants
PMSA-PET/MRI	Late Genitourinary Toxicity After Radiation	Rectal fistula (gastrointestinal toxicity)	1 Participants
PMSA-PET/MRI	Late Genitourinary Toxicity After Radiation	Rectal ulcer (gastrointestinal toxicity)	1 Participants
PMSA-PET/MRI	Late Genitourinary Toxicity After Radiation	Fecal incontinence	1 Participants
PMSA-PET/MRI	Late Genitourinary Toxicity After Radiation	Kidney infection (Pyelonephritis)	1 Participants

Secondary

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