Trial Outcomes & Findings for Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes (NCT NCT03762759)

Last Updated: 2026-08-07

Results Overview

A survival analysis will be conducted on disease-free survival (DFS). The survivor functions for DFS will be estimated with Kaplan and Meier method and plotted. The logrank test will be used to test the difference in DFS of (a) both arms in aggregate with the survivor function on our prior R01 trial and (b) between the two study arms.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

140 participants

Primary outcome timeframe

Up to 2 years after study start

Results posted on

2026-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Fluciclovine F18, PET/CT) Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT
Overall Study STARTED	70	70
Overall Study COMPLETED	65	69
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Fluciclovine F18, PET/CT) n=70 Participants Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) n=70 Participants Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=20 Participants	40 Participants n=20 Participants	86 Participants n=40 Participants
Age, Categorical >=65 years	24 Participants n=20 Participants	30 Participants n=20 Participants	54 Participants n=40 Participants
Age, Continuous	62 Years n=20 Participants	65 Years n=20 Participants	63.0 Years n=40 Participants
Sex: Female, Male Female	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Sex: Female, Male Male	70 Participants n=20 Participants	70 Participants n=20 Participants	140 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	3 Participants n=20 Participants	2 Participants n=20 Participants	5 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	22 Participants n=20 Participants	29 Participants n=20 Participants	51 Participants n=40 Participants
Race (NIH/OMB) White	45 Participants n=20 Participants	39 Participants n=20 Participants	84 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Region of Enrollment United States	70 participants n=20 Participants	70 participants n=20 Participants	140 participants n=40 Participants

PRIMARY outcome

Timeframe: Up to 2 years after study start

Outcome measures

Outcome measures
Measure	Arm I (Fluciclovine F18, PET/CT) n=59 Participants Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) n=60 Participants Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT
Percentage of Participants Disease-Free at 2 Years	87 Percentage of Participants Interval 74.6 to 93.6	88 Percentage of Participants Interval 75.9 to 93.9

SECONDARY outcome

Timeframe: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks

Decision to offer radiotherapy or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.

Outcome measures

Outcome measures
Measure	Arm I (Fluciclovine F18, PET/CT) n=65 Participants Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) n=69 Participants Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT
Decision to Offer Radiotherapy Pre-PET: RT offered	65 Participants	69 Participants
Decision to Offer Radiotherapy Post-PET: RT offered	60 Participants	61 Participants
Decision to Offer Radiotherapy Overall decision change	19 Participants	29 Participants

SECONDARY outcome

Timeframe: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks

Decision to provide treatment on pelvic nodes or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.

Outcome measures

Outcome measures
Measure	Arm I (Fluciclovine F18, PET/CT) n=65 Participants Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) n=69 Participants Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT
Decision to Treat Pelvic Nodes Field decision change	43 Participants	33 Participants
Decision to Treat Pelvic Nodes Pre-PET: Pelvis included	34 Participants	40 Participants
Decision to Treat Pelvic Nodes Post-PET: Pelvis included	15 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks

Decision to boost or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.

Outcome measures

Outcome measures
Measure	Arm I (Fluciclovine F18, PET/CT) n=59 Participants Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) n=60 Participants Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT
Decision to Boost Between the Initial and Final Treatment Decisions Pre-PET: Boost planned	0 Participants	0 Participants
Decision to Boost Between the Initial and Final Treatment Decisions Post-PET: Boost planned	42 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks

Population: Not all patients received radiation to the pelvic lymph nodes. Only patients who received pelvic lymph node radiation have pelvic lymph node volume measurements.

Paired t-test will be used to compare the target volumes (CTV and PTV) and the planned dose delivered to surrounding bladder, rectum, and penile bulb between the initial (pre-positron emission tomography \[PET\]) and final (post-PET) radiation treatment plans.

Outcome measures

Outcome measures
Measure	Arm I (Fluciclovine F18, PET/CT) n=70 Participants Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) n=70 Participants Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT
Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV) Planning Target Volume (PTVPB) Pre-PET	279.8 Cubic Centimeters Standard Deviation 73.8	286.2 Cubic Centimeters Standard Deviation 86.4
Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV) Clinical Target Volume Prostate Bed (CTVPB) Pre-PET	115.2 Cubic Centimeters Standard Deviation 36.4	121.2 Cubic Centimeters Standard Deviation 46.2
Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV) Clinical Target Volume Prostate Bed (CTVPB) Post-PET	115.74 Cubic Centimeters Standard Deviation 36.6	121.4 Cubic Centimeters Standard Deviation 46.2
Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV) Clinical Target Volume - Pelvis (CTVPLV) Pre-PET	469.73 Cubic Centimeters Standard Deviation 141.0	465.8 Cubic Centimeters Standard Deviation 111.4
Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV) Clinical Target Volume - Pelvis (CTVPLV) Post-PET	472.73 Cubic Centimeters Standard Deviation 141.6	466.8 Cubic Centimeters Standard Deviation 111.0
Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV) Planning Target Volume (PTVPB) Post-PET	282.2 Cubic Centimeters Standard Deviation 73.2	287.8 Cubic Centimeters Standard Deviation 86.0
Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV) Planning Target Volume (PTVPLV) Pre-PET	1048.6 Cubic Centimeters Standard Deviation 274.6	1034 Cubic Centimeters Standard Deviation 176.0
Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV) Planning Target Volume (PTVPLV) Post-PET	1056.8 Cubic Centimeters Standard Deviation 276.2	1044.4 Cubic Centimeters Standard Deviation 173.2

SECONDARY outcome

Timeframe: Up to 4 weeks post-treatment

Population: Dose volume histogram endpoints were correlated with each grade of toxicity separately. The number of patients having grade 0 gastrointestinal (GI) toxicity is a subset of the overall number of patients so will be a smaller number than the overall number analyzed, and similarly for grade 1 GI toxicity and for grade 2 GI toxicity. Note: 'grade' is level of GI toxicity as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (grade 0=no toxicity, grade 5=death).

Spearman's correlation coefficient will be used to measure the correlations of the Rectum dosimetric endpoints (Rectum 65 and Rectum V40) with the grades (0, 1, 2, or 3) (as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) with acute gastrointestinal (GI) toxicity. A Wald test will be used to test the significance level of their correlations.

Outcome measures

Outcome measures
Measure	Arm I (Fluciclovine F18, PET/CT) n=59 Participants Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) n=60 Participants Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT
Quality of Life: Dose Volume Histogram (DVH) of the Rectum (Percentage of Rectum Receiving 65 Gy (Rectum V65), and 40 Gy (Rectum V40)) Rectum V40 - Grade 0	35.6 Percentage of organ volume Standard Deviation 11.0	40 Percentage of organ volume Standard Deviation 12.8
Quality of Life: Dose Volume Histogram (DVH) of the Rectum (Percentage of Rectum Receiving 65 Gy (Rectum V65), and 40 Gy (Rectum V40)) Rectum V40 - Grade 2	46.2 Percentage of organ volume Standard Deviation 10.2	49.4 Percentage of organ volume Standard Deviation NA \*N/A = standard deviation not calculable; estimate based on a single observation (n=1)
Quality of Life: Dose Volume Histogram (DVH) of the Rectum (Percentage of Rectum Receiving 65 Gy (Rectum V65), and 40 Gy (Rectum V40)) Rectum V40 - Grade 1	29.4 Percentage of organ volume Standard Deviation 10.6	38.2 Percentage of organ volume Standard Deviation 13.6
Quality of Life: Dose Volume Histogram (DVH) of the Rectum (Percentage of Rectum Receiving 65 Gy (Rectum V65), and 40 Gy (Rectum V40)) Rectum V65 - Grade 0	14 Percentage of organ volume Standard Deviation 6.2	14.8 Percentage of organ volume Standard Deviation 6.2
Quality of Life: Dose Volume Histogram (DVH) of the Rectum (Percentage of Rectum Receiving 65 Gy (Rectum V65), and 40 Gy (Rectum V40)) Rectum V65 - Grade 1	11 Percentage of organ volume Standard Deviation 5.6	13.4 Percentage of organ volume Standard Deviation 6.8
Quality of Life: Dose Volume Histogram (DVH) of the Rectum (Percentage of Rectum Receiving 65 Gy (Rectum V65), and 40 Gy (Rectum V40)) Rectum V65 - Grade 2	18.4 Percentage of organ volume Standard Deviation 5.8	24.6 Percentage of organ volume Standard Deviation NA \*N/A = standard deviation not calculable; estimate based on a single observation (n=1)

SECONDARY outcome

Timeframe: Up to 4 weeks post-treatment.

Population: Dose volume histogram endpoints were correlated with each grade of toxicity separately. The number of patients having grade 0 genitourinary (GU) toxicity is a subset of the overall number of patients so will be a smaller number than the overall number analyzed, and similarly for grade 1 GU toxicity and for grade 2 GU toxicity. Note: 'grade' is level of GU toxicity as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (grade 0=no toxicity, grade 5=death).

Spearman's correlation coefficient will be used to measure the correlations of the Bladder dosimetric endpoints (Bladder V65 and Bladder V40) with the grades (0, 1, 2, or 3) (as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) with acute genitourinary (GU) toxicity. A Wald test will be used to test the significance level of their correlations.

Outcome measures

Outcome measures
Measure	Arm I (Fluciclovine F18, PET/CT) n=59 Participants Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) n=60 Participants Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT
Quality of Life: Dose Volume Histogram (DVH) of the Bladder (Percentage of Bladder Receiving 65 Gy (Bladder V65), and 40 Gy (Bladder V40)) Bladder V40 - Grade 0	43.4 Percentage of organ volume Standard Deviation 17.0	44.2 Percentage of organ volume Standard Deviation 17.8
Quality of Life: Dose Volume Histogram (DVH) of the Bladder (Percentage of Bladder Receiving 65 Gy (Bladder V65), and 40 Gy (Bladder V40)) Bladder V40 - Grade 1	46.8 Percentage of organ volume Standard Deviation 19.4	46.4 Percentage of organ volume Standard Deviation 20.4
Quality of Life: Dose Volume Histogram (DVH) of the Bladder (Percentage of Bladder Receiving 65 Gy (Bladder V65), and 40 Gy (Bladder V40)) Bladder V40 - Grade 2	42 Percentage of organ volume Standard Deviation 17.8	44.2 Percentage of organ volume Standard Deviation 18.4
Quality of Life: Dose Volume Histogram (DVH) of the Bladder (Percentage of Bladder Receiving 65 Gy (Bladder V65), and 40 Gy (Bladder V40)) Bladder V65 - Grade 0	22.2 Percentage of organ volume Standard Deviation 14.0	21.6 Percentage of organ volume Standard Deviation 10.0
Quality of Life: Dose Volume Histogram (DVH) of the Bladder (Percentage of Bladder Receiving 65 Gy (Bladder V65), and 40 Gy (Bladder V40)) Bladder V65 - Grade 1	24 Percentage of organ volume Standard Deviation 13.8	24.8 Percentage of organ volume Standard Deviation 15.0
Quality of Life: Dose Volume Histogram (DVH) of the Bladder (Percentage of Bladder Receiving 65 Gy (Bladder V65), and 40 Gy (Bladder V40)) Bladder V65 - Grade 2	22.2 Percentage of organ volume Standard Deviation 11.8	26 Percentage of organ volume Standard Deviation 15.8

Adverse Events

Arm I (Fluciclovine F18, PET/CT)

Serious events: 2 serious events

Other events: 46 other events

Deaths: 1 deaths

Arm II (68Ga-PSMA, PET/CT)

Serious events: 1 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Fluciclovine F18, PET/CT) n=70 participants at risk Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) n=70 participants at risk Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT
Renal and urinary disorders Urethral Stricture	2.9% 2/70 • Number of events 2 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	1.4% 1/70 • Number of events 1 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.

Other adverse events

Other adverse events
Measure	Arm I (Fluciclovine F18, PET/CT) n=70 participants at risk Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Fluciclovine F18: Given IV Positron Emission Tomography: Undergo PET/CT	Arm II (68Ga-PSMA, PET/CT) n=70 participants at risk Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. Computed Tomography: Undergo PET/CT Gallium Ga68-labeled PSMA-11: Given IV Positron Emission Tomography: Undergo PET/CT
Gastrointestinal disorders Acute GI toxicity: Grade 3	0.00% 0/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	0.00% 0/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Renal and urinary disorders Late GU toxicity: Grade 1	45.7% 32/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	58.6% 41/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Renal and urinary disorders Late GU toxicity: Grade 2	15.7% 11/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	11.4% 8/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Renal and urinary disorders Late GU toxicity: Grade 3	2.9% 2/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	1.4% 1/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Gastrointestinal disorders Late GI toxicity: Grade 1	22.9% 16/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	24.3% 17/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Gastrointestinal disorders Late GI toxicity: Grade 2	4.3% 3/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	0.00% 0/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Gastrointestinal disorders Late GI toxicity: Grade 3	0.00% 0/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	0.00% 0/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Gastrointestinal disorders Acute GI toxicity: Grade 2	4.3% 3/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	1.4% 1/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Renal and urinary disorders Acute GU toxicity: Grade 1	47.1% 33/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	60.0% 42/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Renal and urinary disorders Acute GU toxicity: Grade 2	14.3% 10/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	5.7% 4/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Renal and urinary disorders Acute GU toxicity: Grade 3	0.00% 0/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	0.00% 0/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.
Gastrointestinal disorders Acute GI toxicity: Grade 1	30.0% 21/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.	35.7% 25/70 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 24.

Additional Information

Dr. Ashesh Jani

Emory University

Phone: 404-778-1900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place