177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03545165
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 26.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Phase I dose escalation study with combination of 177Lu-J591 and 177Lu-PSMA-617 using a dose-fractionated regimen will be performed in patients with documented progressive metastatic CRPC. The cumulative 177Lu-J591 dose for each subject will be 2.7 GBq/m2 (73 mCi/m2) of 177Lu with 20 mg J591 and the cumulative 177Lu-PSMA-617 dose for each subject will vary (depending on the Cohort) from 3.7 GBq (100 mCi) to 18.5 GBq (500 mCi). The 177Lu-PSMA-617 dose will be escalated in up to 6 different dose levels (3+3 dose-escalation study / de-escalation design). For the phase II portion, a minimum number of 14 patients will be enrolled at MTD (including those enrolled at MTD in Phase I) and a maximum of 24.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: 177Lu-PSMA-617; Drug: 177Lu-J591; Drug: 68Ga-PSMA-HBED-CC	Phase 1/Phase 2

Detailed Description

This is an open-label, single-center Phase I dose-escalation study designed to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of combination of 177Lu-J591 and 177Lu-PSMA-617 in a two-week dose-fractionation regimen. 177Lu-J591 will be given at a moderate dose previously demonstrated to be safe x2 infusions two weeks apart. For 177Lu-PSMA-617 the dose escalation will start at 3.7 GBq (100 mCi) and escalate in increments of 1.85 GBq (50 mCi) for each dose to a planned maximum of 9.25 GBq (250 mCi) x2 doses, 2 weeks apart. Should there be unacceptable toxicity at the initial dose level, we will de-escalate to dose level -1 (1.85 GBq / 50 mCi per dose). After the phase I study has established a MTD, the Phase II, single-arm trial will start.

Patients must have documented progressive metastatic CRPC disease based on Prostate Cancer Working Group 3 (PCWG3) criteria in order to be eligible for enrollment. Upon meeting the inclusion and exclusion criteria and signing the informed consent and HIPPA form, subjects will undergo the screening. As part of the screening, subjects will get a single dose of 68Ga-PSMA-HBED-CC and will have a PET/CT. Nuclear Medicine physician(s) will review the PET/CT scans to document PSMA expression at tumor site(s).

Subjects will have Lutetium-177 Planar/SPECT Imaging on Day 8 (±1 day) after the first dose of 177Lu-J591 + 177Lu-PSMA-617. Optimal images will be performed on selected consenting subjects between the initial treatment visit #1 on Day 1 and Day 4 and prior to treatment visit #2 on D15 ±1. Subjects will be closely monitored for AEs (weekly x2 weeks, then every 2 weeks for one month, at 8 and 12 weeks, and then every 4 weeks for next 3 months).

Upon completion of investigational treatment with dose-fractionation regimen of the combination of 177Lu-J591 + 177Lu-PSMA-617, subjects will undergo 68Ga-PSMA-HBED-CC injection and same day PET/CT at the end of study visit to document treatment response. Subsequently survival data and additional treatment(s) information will be captured from their routine Standard of care (SOC) visits.

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Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Dose-Escalation Trial of Combination Fractionated-dose 177Lu-J591 and 177Lu-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer
• Actual Study Start Date: Apr 18, 2018
• Actual Primary Completion Date: Jul 15, 2020
• Actual Study Completion Date: Jul 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Subjects 177Lu-PSMA-617 [1.85 GBq (50 mCi) - 9.25 GBq (250 mCi)] x2 doses, 2 weeks apart (Treatment Visit #1 and #2), IV administration 177Lu-J591 [1.35 GBq/m2 or 36.5 mCi/m2] x2 doses, 2 weeks apart (Treatment Visit #1 and #2), IV administration 68Ga-PSMA-HBED-CC [185 ±74 MBq or 5 ±2 mCi] intravenous during screening and at 12 weeks (±1 week) with standard imaging	Drug: 177Lu-PSMA-617; [1.85 GBq (50 mCi) - 9.25 GBq (250 mCi)]; Drug: 177Lu-J591; [1.35 GBq/m2 or 36.5 mCi/m2]; Drug: 68Ga-PSMA-HBED-CC; [185 ±74MBq or 5 ±2 mCi]

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Dose Limiting Toxicity (DLT) of Combination Therapy in a 2-Week Dose-Fractionation Regimen [Approximately 3 months after enrollment]

   Dose limiting toxicity of combination therapy was determined by monitoring for adverse events following therapy

2. Cumulative Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of Combination Therapy in a 2-Week Dose-Fractionation Regimen [Approximately 3 months after enrollment]

   Cumulative maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of combination therapy was determined by monitoring dose-limiting toxicity and adverse events in the dosing or treatment cohorts

3. The Proportion With PSA Decline Following the Dose-Fractionated Combination Therapy by Comparing the Change in PSA Levels After Therapy to the Baseline, Pre-Treatment PSA. [At baseline and at 2 weeks on therapy]

   The proportion of patients with PSA decline following treatment with the combination of 177Lu-J591 and 177Lu-PSMA-617 was determined by comparing PSA levels prior to and following radionuclide therapy

Secondary Outcome Measures

1. Number of Subjects With Radiographic Response by RECIST 1.1 With Prostate Cancer Working Group 3 (PCWG3) Modifications [At the efficacy (scan) visit time point (12 weeks)]

   Radiographic response rate was determined by scoring follow-up scans after therapy; RECIST 1.1 criteria with PCWG3 modifications were utilized

2. Biochemical Progression-Free Survival by PCWG3 Criteria [Through study completion, up to 26 months]

   Biochemical progression-free survival was determined from date of first therapy to date of progression by PSA

3. Radiographic Progression-Free Survival by PCWG3 Criteria [Through study completion, up to 26 months]

   Radiographic progression-free survival was determined from date of first treatment to date of progression on follow-up imaging

4. Overall Survival Following Treatment With the Combination of 177Lu-J591 and 177Lu-PSMA-617 in a 2-Week Dose-Fractionation Regimen [Through study completion, up to 26 months]

   Overall survival following treatment with the combination of 177Lu-J591 and 177Lu-PSMA-617 was determined from date of first treatment to date of death

5. Changes in CTC Count as Measured by CellSearch [At the efficacy (scan) visit time point (12 weeks)]

   Patients' circulating tumor cell counts were obtained prior to and following therapy

6. Rate of Favorable CTC Count as Measured by Cell Search [At the efficacy (scan) visit time point (12 weeks)]

   Patients' circulating tumor cell counts were obtained prior to and following therapy

7. Rate of Favorable LDH Count [During treatment phase, then every 4 weeks until radiographic progression, assessed up to 6 months]

   Patient's LDH values were monitored prior to and following therapy

Other Outcome Measures

1. Disease Assessment With PSMA-Ligand Based Imaging Prior to and Following Investigational Treatment [Up to 12 weeks]

   Patients underwent Gallium-68 PSMA PET prior to investigational therapy, and lesions were scored based on SUVmax

2. Radiation Dosimetry of Combination Therapy [Up to 12 weeks]

   Patients underwent SPECT following administration of radionuclides

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of prostate

2. Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria:

1. PSA progression ii. Objective radiographic progression in soft tissue iii. New bone lesions

1. ECOG performance status of 0-2

2. Have serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone bilateral orchiectomy.

3. Have previously been treated with at least one of the following:

• Androgen receptor signaling inhibitor (such as enzalutamide)

• CYP 17 inhibitor (such as abiraterone acetate)

1. Have previously received taxane chemotherapy, been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy.

2. Age > 18 years

3. Patients must have normal organ and marrow function as defined below:

• Absolute neutrophil count >2,000 cells/mm3

• Hemoglobin ≥9 g/dL

• Platelet count >150,000 x 109/L

• Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault

• Serum total bilirubin<1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal)

• Serum AST and ALT<1.5 x ULN in the absence of liver metastases; <3 x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria)

1. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Implantation of investigational medical device ≤4 weeks of Treatment visit #1 (Day 1) or current enrollment in oncologic investigational drug or device study

2. Use of investigational drugs ≤4 weeks or <5 half-lives of Treatment visit # 1(Day 1) or current enrollment in investigational oncology drug or device study

3. Prior systemic beta-emitting bone-seeking radioisotopes

4. Known active brain metastases or leptomeningeal disease

5. History of deep vein thrombosis and/or pulmonary embolus within 1 month of Treatment visit #1

6. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study

7. Radiation therapy for treatment of PC ≤4 weeks of Treatment visit #1

8. Patients on stable dose of bisphosphonates or denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the DLT-assessment period of the study.

9. Having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 month after last study drug administration

10. Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse.

11. Known history of known myelodysplastic syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10021

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Scott Tagawa, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 19, 2019

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03545165
• Other Study ID Numbers: 1802018988
• First Posted: Jun 4, 2018
• Last Update Posted: Aug 24, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Gallium 68 PSMA-11; 177Lu-PSMA-617

Study Results

Participant Flow

Pre-assignment Detail	All 6 patients enrolled received both doses.

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Overall Participants	6
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	73
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	6 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 16.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	4 66.7%
More than one race	0 0%
Unknown or Not Reported	1 16.7%
Region of Enrollment (participants) [Number]
United States	6 100%
Prostate specific antigen (PSA) ((ng/mL)) [Median (Full Range) ]
Median (Full Range) [(ng/mL)]	94
ECOG score (Count of Participants)
0	0 0%
1	6 100%
Halabi (CALGB) score (Count of Participants)
Intermediate	2 33.3%
High	4 66.7%
Bone metastases (Count of Participants)
Present	6 100%
Absent	0 0%
Lymph node metastases (Count of Participants)
Present	4 66.7%
Absent	2 33.3%
Visceral metastases (Count of Participants)
Present	3 50%
Absent	3 50%
Prior androgen receptor pathway inhibitor (Count of Participants)
Received	6 100%
Did not receive	0 0%
Prior chemotherapy (Count of Participants)
Received	5 83.3%
Did not receive	1 16.7%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Dose Limiting Toxicity (DLT) of Combination Therapy in a 2-Week Dose-Fractionation Regimen
Description	Dose limiting toxicity of combination therapy was determined by monitoring for adverse events following therapy
Time Frame	Approximately 3 months after enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Count of Participants [Participants]	1 16.7%

2. Primary Outcome

Title	Cumulative Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of Combination Therapy in a 2-Week Dose-Fractionation Regimen
Description	Cumulative maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of combination therapy was determined by monitoring dose-limiting toxicity and adverse events in the dosing or treatment cohorts
Time Frame	Approximately 3 months after enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Number [mCi]	320

3. Primary Outcome

Title	The Proportion With PSA Decline Following the Dose-Fractionated Combination Therapy by Comparing the Change in PSA Levels After Therapy to the Baseline, Pre-Treatment PSA.
Description	The proportion of patients with PSA decline following treatment with the combination of 177Lu-J591 and 177Lu-PSMA-617 was determined by comparing PSA levels prior to and following radionuclide therapy
Time Frame	At baseline and at 2 weeks on therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Count of Participants [Participants]	5 83.3%

4. Secondary Outcome

Title	Number of Subjects With Radiographic Response by RECIST 1.1 With Prostate Cancer Working Group 3 (PCWG3) Modifications
Description	Radiographic response rate was determined by scoring follow-up scans after therapy; RECIST 1.1 criteria with PCWG3 modifications were utilized
Time Frame	At the efficacy (scan) visit time point (12 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Count of Participants [Participants]	3 50%

5. Secondary Outcome

Title	Biochemical Progression-Free Survival by PCWG3 Criteria
Description	Biochemical progression-free survival was determined from date of first therapy to date of progression by PSA
Time Frame	Through study completion, up to 26 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Median (Full Range) [months]	2.5

6. Secondary Outcome

Title	Radiographic Progression-Free Survival by PCWG3 Criteria
Description	Radiographic progression-free survival was determined from date of first treatment to date of progression on follow-up imaging
Time Frame	Through study completion, up to 26 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Median (Full Range) [months]	2

7. Secondary Outcome

Title	Overall Survival Following Treatment With the Combination of 177Lu-J591 and 177Lu-PSMA-617 in a 2-Week Dose-Fractionation Regimen
Description	Overall survival following treatment with the combination of 177Lu-J591 and 177Lu-PSMA-617 was determined from date of first treatment to date of death
Time Frame	Through study completion, up to 26 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Median (Full Range) [months]	8

8. Secondary Outcome

Title	Changes in CTC Count as Measured by CellSearch
Description	Patients' circulating tumor cell counts were obtained prior to and following therapy
Time Frame	At the efficacy (scan) visit time point (12 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Decline	2 33.3%
Increase	4 66.7%

9. Secondary Outcome

Title	Rate of Favorable CTC Count as Measured by Cell Search
Description	Patients' circulating tumor cell counts were obtained prior to and following therapy
Time Frame	At the efficacy (scan) visit time point (12 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Count of Participants [Participants]	0 0%

10. Secondary Outcome

Title	Rate of Favorable LDH Count
Description	Patient's LDH values were monitored prior to and following therapy
Time Frame	During treatment phase, then every 4 weeks until radiographic progression, assessed up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Count of Participants [Participants]	5 83.3%

11. Other Pre-specified Outcome

Title	Disease Assessment With PSMA-Ligand Based Imaging Prior to and Following Investigational Treatment
Description	Patients underwent Gallium-68 PSMA PET prior to investigational therapy, and lesions were scored based on SUVmax
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Highest lesion SUVmax > 5x liver SUVmean	3 50%
Highest lesion SUVmax 2.5-5x liver SUVmean	2 33.3%
Highest lesion SUVmax 1-2.5x liver SUVmean	1 16.7%

12. Other Pre-specified Outcome

Title	Radiation Dosimetry of Combination Therapy
Description	Patients underwent SPECT following administration of radionuclides
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
Measure Participants	6
Tumor uptake at known sites of disease based on post-treatment planar imaging	6 100%
No tumor uptake	0 0%

Adverse Events

Time Frame	minimum of 30 days following last dose of study drug, up to 26 months
Adverse Event Reporting Description	Adverse events were assessed and documented at each scheduled study visit and follow-up visit. Serious adverse events include death, life threatening adverse experiences, hospitalization or prolongation of hospitalization, disability or incapacitation, overdose, congenital anomalies and any other serious events that may jeopardize the subject or require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Arm/Group Title	Cohort 1
Arm/Group Description	Participants received two doses of 177Lu-J591 (60 mCi) + 177Lu-PSMA-617 (100 mCi), two weeks apart, with minimum 12 weeks of follow-up after last dose.
All Cause Mortality
	Cohort 1
	Affected / at Risk (%)	# Events
Total	6/6 (100%)
Serious Adverse Events
	Cohort 1
	Affected / at Risk (%)	# Events
Total	2/6 (33.3%)
Metabolism and nutrition disorders
dehydration	1/6 (16.7%)
Musculoskeletal and connective tissue disorders
back pain	1/6 (16.7%)
Other (Not Including Serious) Adverse Events
	Cohort 1
	Affected / at Risk (%)	# Events
Total	6/6 (100%)
Blood and lymphatic system disorders
anemia	3/6 (50%)
anemia	2/6 (33.3%)
Gastrointestinal disorders
Anorexia	3/6 (50%)
xerostomia	4/6 (66.7%)
vomiting	1/6 (16.7%)
diarrhea	1/6 (16.7%)
nausea	1/6 (16.7%)
General disorders
fatigue	4/6 (66.7%)
transfusion reaction	1/6 (16.7%)
Investigations
aspartate aminotransferase increased	1/6 (16.7%)
blood bilirubin increased	1/6 (16.7%)
creatinine increased	1/6 (16.7%)
alkaline phosphatase increased	2/6 (33.3%)
white blood cell decreased	2/6 (33.3%)
white blood cell decreased	1/6 (16.7%)
white blood cell decreased	1/6 (16.7%)
lymphocyte count decreased	3/6 (50%)
lymphocyte count decreased	3/6 (50%)
neutrophil count decreased	3/6 (50%)
neutrophil count decreased	2/6 (33.3%)
platelet count decreased	3/6 (50%)
platelet count decreased	1/6 (16.7%)
platelet count decreased	1/6 (16.7%)
Metabolism and nutrition disorders
hypocalcemia	2/6 (33.3%)
hypokalemia	1/6 (16.7%)
Musculoskeletal and connective tissue disorders
osteonecrosis of jaw	1/6 (16.7%)
bone pain	2/6 (33.3%)
Nervous system disorders
peripheral motor neuropathy	1/6 (16.7%)
Renal and urinary disorders
hyperkalemia	2/6 (33.3%)
hematuria	2/6 (33.3%)
urinary tract obstruction	1/6 (16.7%)
Respiratory, thoracic and mediastinal disorders
Cough	2/6 (33.3%)
dyspnea	3/6 (50%)
Skin and subcutaneous tissue disorders
bruising	2/6 (33.3%)

Limitations/Caveats

The study was terminated early due to sponsor withdrawal (PSMA-617 no longer available for purchase).

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.