Trial Outcomes & Findings for PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study (NCT NCT04176497)

NCT ID: NCT04176497

Last Updated: 2025-12-11

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: Up to 22 weeks (3 months after completion of radiation therapy)
• Results posted on: 2025-12-11

Participant Flow

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

Participant milestones

Measure	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.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PMSA-PET/MRI n=8 Participants 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.
Age, Continuous	67.38 years n=237 Participants
Sex: Female, Male Female	0 Participants n=237 Participants
Sex: Female, Male Male	8 Participants n=237 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=237 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=237 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=237 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=237 Participants
Race (NIH/OMB) Asian	0 Participants n=237 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=237 Participants
Race (NIH/OMB) Black or African American	4 Participants n=237 Participants
Race (NIH/OMB) White	4 Participants n=237 Participants
Race (NIH/OMB) More than one race	0 Participants n=237 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=237 Participants
Region of Enrollment United States	8 participants n=237 Participants

PRIMARY outcome

Timeframe: Up to 22 weeks (3 months after completion of radiation therapy)

Population: Participants started study treatment

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.

Outcome measures

Measure	PMSA-PET/MRI n=8 Participants 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.	3 Months Data were collected at 3 moths	6 Months Data collected at 6 months	9 Months Data collected at 9 months	12 Months Data collected at 12 months	18 Months Data collected at 18 months	24 Months Data collected at 24 months	30 Months Data collected at 30 months	36 Months Data collected at 36 months	42 Months Data collected at 42 months
Early Genitourinary and Gastrointestinal Toxicity	0 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Three months after starting radiation therapy to up to 48 months post-treatment

Population: Participants who started study 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

Outcome measures

Measure	PMSA-PET/MRI n=8 Participants 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.	3 Months Data were collected at 3 moths	6 Months Data collected at 6 months	9 Months Data collected at 9 months	12 Months Data collected at 12 months	18 Months Data collected at 18 months	24 Months Data collected at 24 months	30 Months Data collected at 30 months	36 Months Data collected at 36 months	42 Months Data collected at 42 months
Late Genitourinary Toxicity After Radiation Proctitis (gastrointestinal toxicity)	1 Participants	—	—	—	—	—	—	—	—	—
Late Genitourinary Toxicity After Radiation Rectal fistula (gastrointestinal toxicity)	1 Participants	—	—	—	—	—	—	—	—	—
Late Genitourinary Toxicity After Radiation Rectal ulcer (gastrointestinal toxicity)	1 Participants	—	—	—	—	—	—	—	—	—
Late Genitourinary Toxicity After Radiation Fecal incontinence	1 Participants	—	—	—	—	—	—	—	—	—
Late Genitourinary Toxicity After Radiation Kidney infection (Pyelonephritis)	1 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Biochemical control will be defined according to the Phoenix criteria (PSA rise of <2 ng/mL over nadir). Number of subjects

Outcome measures

Measure	PMSA-PET/MRI n=4 Participants 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.	3 Months Data were collected at 3 moths	6 Months Data collected at 6 months	9 Months Data collected at 9 months	12 Months Data collected at 12 months	18 Months Data collected at 18 months	24 Months Data collected at 24 months	30 Months Data collected at 30 months	36 Months Data collected at 36 months	42 Months Data collected at 42 months
Biochemical Control Using Prostate-Specific Antigen (PSA) Levels Biochemical control achieved	4 Participants	—	—	—	—	—	—	—	—	—
Biochemical Control Using Prostate-Specific Antigen (PSA) Levels Biochemical control not achieved	0 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy

Population: Participants started to study intervention.

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.

Outcome measures

Measure	PMSA-PET/MRI n=2 Participants 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.	3 Months n=2 Participants Data were collected at 3 moths	6 Months n=3 Participants Data collected at 6 months	9 Months n=2 Participants Data collected at 9 months	12 Months n=2 Participants Data collected at 12 months	18 Months n=2 Participants Data collected at 18 months	24 Months n=2 Participants Data collected at 24 months	30 Months n=3 Participants Data collected at 30 months	36 Months n=2 Participants Data collected at 36 months	42 Months n=1 Participants Data collected at 42 months
Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) Rectal Domain	98.2 score on a scale Standard Deviation 2.5	96.4 score on a scale Standard Deviation 0	94 score on a scale Standard Deviation 5.5	83.9 score on a scale Standard Deviation 7.6	71.4 score on a scale Standard Deviation 15.2	96.4 score on a scale Standard Deviation 5.1	89.3 score on a scale Standard Deviation 15.2	95.2 score on a scale Standard Deviation 8.2	100 score on a scale Standard Deviation 0	100 score on a scale Standard Deviation NA 1 participant

SECONDARY outcome

Timeframe: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy

Population: Participants started to study intervention.

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.

Outcome measures

Measure	PMSA-PET/MRI n=2 Participants 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.	3 Months n=2 Participants Data were collected at 3 moths	6 Months n=3 Participants Data collected at 6 months	9 Months n=2 Participants Data collected at 9 months	12 Months n=2 Participants Data collected at 12 months	18 Months n=2 Participants Data collected at 18 months	24 Months n=2 Participants Data collected at 24 months	30 Months n=3 Participants Data collected at 30 months	36 Months n=1 Participants Data collected at 36 months	42 Months n=1 Participants Data collected at 42 months
Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) - Urinary Domain	63.1 score on a scale Standard Deviation 28.7	64.4 score on a scale Standard Deviation 8.4	68.7 score on a scale Standard Deviation 15.3	51.8 score on a scale Standard Deviation 26.2	22.6 score on a scale Standard Deviation 6.8	53.6 score on a scale Standard Deviation 3.3	69.7 score on a scale Standard Deviation 7.7	92.9 score on a scale Standard Deviation 9.4	78.7 score on a scale Standard Deviation NA 1 participant	100 score on a scale Standard Deviation NA 1 participant

SECONDARY outcome

Timeframe: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy

Population: Participants started to study intervention.

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.

Outcome measures

Measure	PMSA-PET/MRI n=3 Participants 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.	3 Months n=2 Participants Data were collected at 3 moths	6 Months n=3 Participants Data collected at 6 months	9 Months n=3 Participants Data collected at 9 months	12 Months n=2 Participants Data collected at 12 months	18 Months n=1 Participants Data collected at 18 months	24 Months n=2 Participants Data collected at 24 months	30 Months n=3 Participants Data collected at 30 months	36 Months n=2 Participants Data collected at 36 months	42 Months n=1 Participants Data collected at 42 months
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Bowel Domain	98.6 score on a scale Standard Deviation 2.4	95.8 score on a scale Standard Deviation 0	86.1 score on a scale Standard Deviation 14.6	77.8 score on a scale Standard Deviation 21	93.8 score on a scale Standard Deviation 2.9	87.5 score on a scale Standard Deviation NA 1 participant	100 score on a scale Standard Deviation 0	88.9 score on a scale Standard Deviation 19.2	100 score on a scale Standard Deviation 0	100 score on a scale Standard Deviation NA 1 participant

SECONDARY outcome

Timeframe: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy

Population: Participants started to study intervention.

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.

Outcome measures

Measure	PMSA-PET/MRI n=2 Participants 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.	3 Months n=2 Participants Data were collected at 3 moths	6 Months n=3 Participants Data collected at 6 months	9 Months n=3 Participants Data collected at 9 months	12 Months n=2 Participants Data collected at 12 months	18 Months n=1 Participants Data collected at 18 months	24 Months n=2 Participants Data collected at 24 months	30 Months n=2 Participants Data collected at 30 months	36 Months n=1 Participants Data collected at 36 months	42 Months n=1 Participants Data collected at 42 months
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Hormonal Function Domain	70 score on a scale Standard Deviation 28.3	57.5 score on a scale Standard Deviation 3.5	88.3 score on a scale Standard Deviation 11.5	83.3 score on a scale Standard Deviation 16.1	95 score on a scale Standard Deviation 7.1	62.5 score on a scale Standard Deviation NA 1 participant	80 score on a scale Standard Deviation 28.3	100 score on a scale Standard Deviation 0	100 score on a scale Standard Deviation NA 1 participant	100 score on a scale Standard Deviation NA 1 participant

SECONDARY outcome

Timeframe: Baseline and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy

Population: Participants started to study intervention.

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.

Outcome measures

Measure	PMSA-PET/MRI n=1 Participants 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.	3 Months n=2 Participants Data were collected at 3 moths	6 Months n=3 Participants Data collected at 6 months	9 Months n=3 Participants Data collected at 9 months	12 Months n=2 Participants Data collected at 12 months	18 Months n=1 Participants Data collected at 18 months	24 Months n=2 Participants Data collected at 24 months	30 Months n=2 Participants Data collected at 30 months	36 Months n=1 Participants Data collected at 36 months	42 Months n=1 Participants Data collected at 42 months
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) -Sexual Function Domain	43 score on a scale Standard Deviation NA 1 participant	31.2 score on a scale Standard Deviation 20.6	12.2 score on a scale Standard Deviation 10.7	8.3 score on a scale Standard Deviation 8.3	25.8 score on a scale Standard Deviation 13	12.5 score on a scale Standard Deviation NA 1 participant	36.8 score on a scale Standard Deviation 46.2	44 score on a scale Standard Deviation 38.9	40.3 score on a scale Standard Deviation NA 1 participant	69.5 score on a scale Standard Deviation NA 1 participant

SECONDARY outcome

Timeframe: at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy

Population: Participants started to study intervention.

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.

Outcome measures

Measure	PMSA-PET/MRI n=3 Participants 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.	3 Months n=2 Participants Data were collected at 3 moths	6 Months n=3 Participants Data collected at 6 months	9 Months n=3 Participants Data collected at 9 months	12 Months n=2 Participants Data collected at 12 months	18 Months n=1 Participants Data collected at 18 months	24 Months n=2 Participants Data collected at 24 months	30 Months n=3 Participants Data collected at 30 months	36 Months n=2 Participants Data collected at 36 months	42 Months n=1 Participants Data collected at 42 months
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Urinary Incontinence, Urinary Irritation Domains Urinary incontinence	84.8 score on a scale Standard Deviation 13.4	76 score on a scale Standard Deviation 33.9	82 score on a scale Standard Deviation 13.4	63.2 score on a scale Standard Deviation 33.9	66.6 score on a scale Standard Deviation 38.4	79.2 score on a scale Standard Deviation NA 1 participant	67.8 score on a scale Standard Deviation 25.1	79.2 score on a scale Standard Deviation 36.1	92.8 score on a scale Standard Deviation 10.3	50 score on a scale Standard Deviation 0
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Urinary Incontinence, Urinary Irritation Domains urinary irritation	62.5 score on a scale Standard Deviation 21.7	53.1 score on a scale Standard Deviation 13.3	89.6 score on a scale Standard Deviation 13	77.1 score on a scale Standard Deviation 29.5	43.8 score on a scale Standard Deviation 17.7	68.8 score on a scale Standard Deviation NA 1 participant	81.2 score on a scale Standard Deviation 8.8	100 score on a scale Standard Deviation 0	100 score on a scale Standard Deviation 0	100 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline

Population: Participants who screened for the study treatment.

The number of participants started study.

Outcome measures

Measure	PMSA-PET/MRI n=8 Participants 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.	3 Months Data were collected at 3 moths	6 Months Data collected at 6 months	9 Months Data collected at 9 months	12 Months Data collected at 12 months	18 Months Data collected at 18 months	24 Months Data collected at 24 months	30 Months Data collected at 30 months	36 Months Data collected at 36 months	42 Months Data collected at 42 months
The Number of Participants Started Study.	8 Participants	—	—	—	—	—	—	—	—	—

Adverse Events

PMSA-PET/MRI

Serious events: 2 serious events

Other events: 8 other events

Deaths: 2 deaths

Serious adverse events

Measure	PMSA-PET/MRI n=8 participants at risk 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.
Gastrointestinal disorders Proctitis	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Rectal ulcer	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Rectal fistula	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Infections and infestations Kidney infection	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Metabolism and nutrition disorders Acidosis	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Metabolism and nutrition disorders Hyperglycemia	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.

Other adverse events

Measure	PMSA-PET/MRI n=8 participants at risk 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.
Vascular disorders Hot flashes	75.0% 6/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Vascular disorders Hypertension	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
General disorders Fatigue	37.5% 3/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Investigations Weight loss	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Metabolism and nutrition disorders Anorexia	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Metabolism and nutrition disorders Hyperlipidemia	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Renal and urinary disorders Urinary incontinence	25.0% 2/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Constipation	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Diarrhea	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Proctitis	25.0% 2/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Rectal pain	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Renal and urinary disorders Chronic kidney disease	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Renal and urinary disorders Dysuria	25.0% 2/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Renal and urinary disorders Urinary frequency	87.5% 7/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Renal and urinary disorders Urinary retention	25.0% 2/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Renal and urinary disorders Urinary urgency	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Reproductive system and breast disorders Breast pain	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Reproductive system and breast disorders Scrotal pain	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Blood and lymphatic system disorders Anemia	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Cardiac disorders Chest pain - cardiac	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
Eye disorders Glaucoma	12.5% 1/8 • Up to 49 months. Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.

Additional Information

Melahat Canter

UNC Lineberger Comprehensive Cancer Center

Phone: 919-966-4432

Email: Melahat_Canter@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place