NCT04176497

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

Terminated Phase 2 Results posted Last updated 11 December 2025

What this trial tests

Phase 2 trial testing 68Ga-HBED-CC-PSMA in Prostate Cancer in 8 participants. Terminated before completion.

Timeline

16 July 2020

Primary endpoint
7 February 2024

25 October 2024

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	16 July 2020
Primary completion	7 February 2024
Estimated completion	25 October 2024
Sites	1 location across United States

Drugs / interventions tested

• 68Ga-HBED-CC-PSMA — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Early Genitourinary and Gastrointestinal Toxicity Primary · 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

Group	Value	95% CI
PMSA-PET/MRI	0

Late Genitourinary Toxicity After Radiation Secondary · 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 instrum

Proctitis (gastrointestinal toxicity)

Group	Value	95% CI
PMSA-PET/MRI	1

Rectal fistula (gastrointestinal toxicity)

Group	Value	95% CI
PMSA-PET/MRI	1

Rectal ulcer (gastrointestinal toxicity)

Group	Value	95% CI
PMSA-PET/MRI	1

Fecal incontinence

Group	Value	95% CI
PMSA-PET/MRI	1

Kidney infection (Pyelonephritis)

Group	Value	95% CI
PMSA-PET/MRI	1

Biochemical Control Using Prostate-Specific Antigen (PSA) Levels Secondary · 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

Biochemical control achieved

Group	Value	95% CI
PMSA-PET/MRI	4

Biochemical control not achieved

Group	Value	95% CI
PMSA-PET/MRI	0

Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) Rectal Domain Secondary · 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 a

Group	Value	95% CI
1 Month	98.2	± 2.5
3 Months	96.4	± 0
6 Months	94	± 5.5
9 Months	83.9	± 7.6
12 Months	71.4	± 15.2
18 Months	96.4	± 5.1
24 Months	89.3	± 15.2
30 Months	95.2	± 8.2
36 Months	100	± 0
42 Months	100	± NA

Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) - Urinary Domain Secondary · 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 a

Group	Value	95% CI
1 Month	63.1	± 28.7
3 Months	64.4	± 8.4
6 Months	68.7	± 15.3
9 Months	51.8	± 26.2
12 Months	22.6	± 6.8
18 Months	53.6	± 3.3
24 Months	69.7	± 7.7
30 Months	92.9	± 9.4
36 Months	78.7	± NA
42 Months	100	± NA

Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Bowel Domain Secondary · 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

Group	Value	95% CI
1 Month	98.6	± 2.4
3 Months	95.8	± 0
6 Months	86.1	± 14.6
9 Months	77.8	± 21
12 Months	93.8	± 2.9
18 Months	87.5	± NA
24 Months	100	± 0
30 Months	88.9	± 19.2
36 Months	100	± 0
42 Months	100	± NA

Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Hormonal Function Domain Secondary · 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

Group	Value	95% CI
1 Month	70	± 28.3
3 Months	57.5	± 3.5
6 Months	88.3	± 11.5
9 Months	83.3	± 16.1
12 Months	95	± 7.1
18 Months	62.5	± NA
24 Months	80	± 28.3
30 Months	100	± 0
36 Months	100	± NA
42 Months	100	± NA

Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) -Sexual Function Domain Secondary · 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 hi

Group	Value	95% CI
1 Month	43	± NA
3 Months	31.2	± 20.6
6 Months	12.2	± 10.7
9 Months	8.3	± 8.3
12 Months	25.8	± 13
18 Months	12.5	± NA
24 Months	36.8	± 46.2
30 Months	44	± 38.9
36 Months	40.3	± NA
42 Months	69.5	± NA

Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Urinary Incontinence, Urinary Irritation Domains Secondary · 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

Urinary incontinence

Group	Value	95% CI
1 Month	84.8	± 13.4
3 Months	76	± 33.9
6 Months	82	± 13.4
9 Months	63.2	± 33.9
12 Months	66.6	± 38.4
18 Months	79.2	± NA
24 Months	67.8	± 25.1
30 Months	79.2	± 36.1
36 Months	92.8	± 10.3
42 Months	50	± 0

urinary irritation

Group	Value	95% CI
1 Month	62.5	± 21.7
3 Months	53.1	± 13.3
6 Months	89.6	± 13
9 Months	77.1	± 29.5
12 Months	43.8	± 17.7
18 Months	68.8	± NA
24 Months	81.2	± 8.8
30 Months	100	± 0
36 Months	100	± 0
42 Months	100	± 0

The Number of Participants Started Study. Secondary · Baseline

The number of participants started study.

Group	Value	95% CI
PMSA-PET/MRI	8

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 49 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PMSA-PET/MRI

Serious: 2/8 (25%)

Deaths: 2/8

Serious adverse events (6 terms)

Reaction	System	PMSA-PET/MRI
Proctitis	Gastrointestinal disorders	—
Rectal ulcer	Gastrointestinal disorders	—
Rectal fistula	Gastrointestinal disorders	—
Kidney infection	Infections and infestations	—
Acidosis	Metabolism and nutrition disorders	—
Hyperglycemia	Metabolism and nutrition disorders	—

Other adverse events (21 terms — click to expand)

Reaction	System	PMSA-PET/MRI
Urinary frequency	Renal and urinary disorders	—
Hot flashes	Vascular disorders	—
Fatigue	General disorders	—
Proctitis	Gastrointestinal disorders	—
Dysuria	Renal and urinary disorders	—
Urinary retention	Renal and urinary disorders	—
Urinary incontinence	Renal and urinary disorders	—
Constipation	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Rectal pain	Gastrointestinal disorders	—
Chronic kidney disease	Renal and urinary disorders	—
Urinary urgency	Renal and urinary disorders	—
Breast pain	Reproductive system and breast disorders	—
Scrotal pain	Reproductive system and breast disorders	—
Anemia	Blood and lymphatic system disorders	—
Chest pain - cardiac	Cardiac disorders	—
Glaucoma	Eye disorders	—
Weight loss	Investigations	—
Anorexia	Metabolism and nutrition disorders	—
Hyperlipidemia	Metabolism and nutrition disorders	—
Hypertension	Vascular disorders	—

Most-reported serious reactions: Proctitis, Rectal ulcer, Rectal fistula, Kidney infection, Acidosis, Hyperglycemia.

Data from ClinicalTrials.gov NCT04176497 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Incorporating PSMA-Targeting Theranostics Into Personalized Prostate Cancer Treatment: a Multidisciplinary Perspective.
   Ng TSC, Gao X, Salari K, Zlatev DV, et al · · 2021 · cited 4× · PMID 34395293 · DOI 10.3389/fonc.2021.722277