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Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy (RESIST-PC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03042312
Recruitment Status : Terminated (Recruitment was stopped before the target sample size was achieved.)
First Posted : February 3, 2017
Results First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Endocyte

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Castration Resistant Prostate Cancer
Intervention Drug: 177Lu-PSMA-617
Enrollment 71
Recruitment Details This study was conducted at 2 centers in the USA
Pre-assignment Details  
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Period Title: Overall Study
Started [1] 28 43
Safety Population [2] 23 41
Completed 18 31
Not Completed 10 12
Reason Not Completed
Administrative Reason             1             1
Adverse Event             0             1
Lost to Follow-up             1             3
Any occurrence of conditions which prevented the patient's participation in the study.             4             2
Withdrawal by Subject             4             5
[1]
All randomized participants were included in Intent-to-treat (ITT) population
[2]
The subset of patients in the ITT population who received at least one dose of randomized therapy.
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq) Total
Hide Arm/Group Description Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry Total of all reporting groups
Overall Number of Baseline Participants 28 43 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 43 participants 71 participants
72.1  (8.39) 69.1  (8.62) 70.3  (8.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 43 participants 71 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
28
 100.0%
43
 100.0%
71
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 43 participants 71 participants
Asian 1 1 2
Black or African American 0 1 1
White 26 41 67
Other 1 0 1
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide Description Treatment-emergent adverse events (TEAEs) were collected from first dosing up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Time Frame From first dosing (Day 0) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent, up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description:
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Overall Number of Participants Analyzed 23 41
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment-Emergent Adverse Events (TEAEs)
22
  95.7%
39
  95.1%
Serious TEAEs
4
  17.4%
8
  19.5%
Drug-related TEAEs
20
  87.0%
37
  90.2%
Serious drug-related TEAEs
1
   4.3%
4
   9.8%
TEAEs leading to reduction of Lu-PSMA-617
0
   0.0%
2
   4.9%
TEAEs leading to discontinuation of Lu-PSMA-617
0
   0.0%
1
   2.4%
TEAEs leading to death
2
   8.7%
1
   2.4%
2.Primary Outcome
Title Number of Participants Achieving PSA Response at Week 12
Hide Description PSA response was defined as the proportion of patients who had a >= 50% decrease in PSA from Baseline at Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis.
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description:
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Overall Number of Participants Analyzed 14 25
Measure Type: Count of Participants
Unit of Measure: Participants
PSA Response (< 50% decline)
5
  35.7%
8
  32.0%
PSA Response (>= 50% decline)
6
  42.9%
6
  24.0%
PSA Response (Increase from Baseline)
3
  21.4%
11
  44.0%
3.Secondary Outcome
Title Percent Change in PSA From Baseline to Week 12
Hide Description Percent change in PSA from Baseline to Week 12 was reported for participants who had a baseline and a week 12 valid assessments.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis.
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description:
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Overall Number of Participants Analyzed 14 25
Mean (Standard Deviation)
Unit of Measure: Percent change in PSA
-22.54  (75.513) 92.15  (301.932)
4.Secondary Outcome
Title Maximum Percent Change in PSA Response
Hide Description Maximal baseline to follow-up PSA decline, at any time during or after therapy was evaluated in both treatment groups.
Time Frame Every 6 weeks during the treatment and every 3 (+/- 1) months after last treatment until reaching endpoint or 24 months after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis.
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description:
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Overall Number of Participants Analyzed 23 40
Mean (Standard Deviation)
Unit of Measure: PSA percent change
-3.63  (95.394) 8.75  (132.954)
5.Secondary Outcome
Title PSA Progression and Death Events
Hide Description

PSA progression was defined as:

  1. For patients with PSA decline: PSA progression was defined as the date that a >= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained 3 or more weeks later. Rises in PSA within the first 12 weeks were ignored (PCWG3 Guidance),
  2. For patients without PSA decline: PSA progression was defined as a >= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks of treatment.
Time Frame Date of randomization to the date of first documented PSA progression or death, whichever occurs first, reported between day of first patient randomized up to 24 months after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description:
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Overall Number of Participants Analyzed 28 43
Measure Type: Count of Participants
Unit of Measure: Participants
Deaths without PSA progression
2
   7.1%
2
   4.7%
Participants with PSA progression, but who did not die
11
  39.3%
17
  39.5%
6.Secondary Outcome
Title RECIST 1.1 Overall Response by Follow-up Assessment Visit
Hide Description

For each follow-up imaging assessment by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target, non-target, and new lesions assessed by CT or MRI: the number of participants with an overall response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).

The timing of follow-up imaging assessments varied depending on how many RLT cycles a participant received. Therefore, regardless of when the imaging assessments occurred, each participant's first follow-up imaging was combined as Follow-up 1, each participant's second follow-up imaging was combined as Follow-up 2, each participant's third follow-up imaging was combined as Follow-up 3, and each participant's fourth follow-up imaging was combined as Follow-up 4.

Time Frame Before 3rd radioligand therapy (RLT) cycle, and then every 3 (+/- 1) months after last treatment dose until disease progression or 24 months after the first treatment dose.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description:
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Overall Number of Participants Analyzed 28 43
Measure Type: Count of Participants
Unit of Measure: Participants
Follow-up 1 Number Analyzed 11 participants 21 participants
Complete Response
1
   9.1%
1
   4.8%
Partial Response
3
  27.3%
4
  19.0%
Stable Disease
1
   9.1%
7
  33.3%
Progressive Disease
6
  54.5%
9
  42.9%
Follow-up 2 Number Analyzed 4 participants 5 participants
Complete Response
3
  75.0%
1
  20.0%
Partial Response
0
   0.0%
3
  60.0%
Stable Disease
0
   0.0%
0
   0.0%
Progressive Disease
1
  25.0%
1
  20.0%
Follow-up 3 Number Analyzed 1 participants 1 participants
Complete Response
1
 100.0%
0
   0.0%
Partial Response
0
   0.0%
0
   0.0%
Stable Disease
0
   0.0%
1
 100.0%
Progressive Disease
0
   0.0%
0
   0.0%
Follow-up 4 Number Analyzed 1 participants 0 participants
Complete Response
0
   0.0%
0
Partial Response
1
 100.0%
0
Stable Disease
0
   0.0%
0
Progressive Disease
0
   0.0%
0
7.Secondary Outcome
Title RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit
Hide Description

The proportion of participants with an overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD) was reported using investigator assessments per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target, non-target, and new lesions assessed by CT or MRI.

The timing of follow-up imaging assessments varied depending on how many RLT cycles a participant received. Therefore, regardless of when the imaging assessments occurred, each participant's first follow-up imaging was combined as Follow-up 1, each participant's second follow-up imaging was combined as Follow-up 2, each participant's third follow-up imaging was combined as Follow-up 3, and each participant's fourth follow-up imaging was combined as Follow-up 4.

Time Frame Before 3rd radioligand therapy (RLT) cycle, and then every 3 (+/- 1) months after last treatment dose until disease progression or 24 months after the first treatment dose.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description:
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Overall Number of Participants Analyzed 28 43
Measure Type: Number
Unit of Measure: Percentage of participants
Follow-up 1 Number Analyzed 5 participants 12 participants
17.9 27.9
Follow-up 2 Number Analyzed 3 participants 4 participants
10.7 9.3
Follow-up 3 Number Analyzed 1 participants 1 participants
3.6 2.3
Follow-up 4 Number Analyzed 1 participants 0 participants
3.6
8.Secondary Outcome
Title Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit
Hide Description Investigator's assessed bone metastases using the Prostate Cancer Working Group 3 (PCWG3) criteria; new lesions had to be confirmed on a second scan (2+2 rule). The investigator documented their clinical impression of each PCWG3 assessment as Improved, Stable or Progression. The number of participants with a clinical impression of Improved, Stable or Progression according to PCWG3 using investigators assessments was reported by visit.
Time Frame Screening, Week 8, Week 10, Week 16, Week 18, Week 22, Week 24, Follow-up Week 4, Follow-up Week 6, Follow-up Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description:
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Overall Number of Participants Analyzed 28 43
Measure Type: Count of Participants
Unit of Measure: Participants
Screening Number Analyzed 1 participants 0 participants
Improved
0
   0.0%
0
Stable
1
 100.0%
0
Progression
0
   0.0%
0
Week 8 Number Analyzed 2 participants 6 participants
Improved
1
  50.0%
3
  50.0%
Stable
1
  50.0%
2
  33.3%
Progression
0
   0.0%
1
  16.7%
Week 10 Number Analyzed 2 participants 4 participants
Improved
0
   0.0%
3
  75.0%
Stable
2
 100.0%
1
  25.0%
Progression
0
   0.0%
0
   0.0%
Week 16 Number Analyzed 2 participants 2 participants
Improved
0
   0.0%
2
 100.0%
Stable
2
 100.0%
0
   0.0%
Progression
0
   0.0%
0
   0.0%
Week 18 Number Analyzed 1 participants 3 participants
Improved
0
   0.0%
0
   0.0%
Stable
0
   0.0%
3
 100.0%
Progression
1
 100.0%
0
   0.0%
Week 22 Number Analyzed 0 participants 1 participants
Improved 0
0
   0.0%
Stable 0
1
 100.0%
Progression 0
0
   0.0%
Week 24 Number Analyzed 0 participants 1 participants
Improved 0
0
   0.0%
Stable 0
1
 100.0%
Progression 0
0
   0.0%
Follow-up Week 4 Number Analyzed 0 participants 1 participants
Improved 0
0
   0.0%
Stable 0
0
   0.0%
Progression 0
1
 100.0%
Follow-up Week 6 Number Analyzed 0 participants 1 participants
Improved 0
0
   0.0%
Stable 0
0
   0.0%
Progression 0
1
 100.0%
Follow-up Week 8 Number Analyzed 2 participants 0 participants
Improved
0
   0.0%
0
Stable
1
  50.0%
0
Progression
1
  50.0%
0
9.Secondary Outcome
Title Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26)
Hide Description The Expanded Prostate Cancer Index-Composite (EPIC) is a well-established patient-reported outcome (PRO) questionnaire developed to monitor health-related quality of life outcomes among prostate cancer. The 26-item version of EPIC, also known as EPIC Short Form or EPIC-26, contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life.
Time Frame Baseline, Month 3, Month 6, Follow-up Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. For each domain, only participants with a value at both baseline and post baseline were included in the analysis.
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description:
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Overall Number of Participants Analyzed 28 43
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
Urinary Incontinence (Baseline) Number Analyzed 20 participants 35 participants
78.3  (26.87) 77.4  (24.64)
Urinary Incontinence (Change from BL@Month 3) Number Analyzed 8 participants 9 participants
4.9  (12.57) 9.7  (20.88)
Urinary Incontinence (Change from BL@Month 6) Number Analyzed 3 participants 7 participants
11.1  (19.20) -6.3  (14.66)
Urinary Incontinence (Change from BL@Follow-up Month 3) Number Analyzed 0 participants 3 participants
-2.1  (9.55)
Urinary Irritative/Obstructive (Baseline) Number Analyzed 19 participants 35 participants
83.2  (20.73) 84.8  (19.13)
Urinary Irritative/Obstructive (Change from BL@Month 3) Number Analyzed 7 participants 9 participants
17.9  (25.37) -1.4  (4.17)
Urinary Irritative/Obstructive (Change from BL@Month 6) Number Analyzed 3 participants 7 participants
2.1  (9.55) 6.3  (8.84)
Urinary Irritative/Obstructive (Change from BL@Follow-up Month 3) Number Analyzed 0 participants 3 participants
8.3  (9.55)
Bowel (Baseline) Number Analyzed 20 participants 32 participants
90.8  (14.60) 88.4  (14.77)
Bowel (Change from BL@Month 3) Number Analyzed 8 participants 9 participants
-1.0  (8.55) 4.0  (18.57)
Bowel (Change from BL@Month 6) Number Analyzed 3 participants 6 participants
-4.2  (8.33) 4.9  (16.75)
Bowel (Change from BL@Follow-up Month 3) Number Analyzed 0 participants 3 participants
-8.3  (18.16)
Sexual (Baseline) Number Analyzed 20 participants 33 participants
8.8  (9.74) 11.7  (19.66)
Sexual (Change from BL@Month 3) Number Analyzed 8 participants 9 participants
-4.4  (11.68) 7.8  (15.76)
Sexual (Change from BL@Month 6) Number Analyzed 3 participants 7 participants
-4.7  (5.02) 7.3  (5.82)
Sexual (Change from BL@Follow-up Month 3) Number Analyzed 0 participants 3 participants
4.6  (4.85)
Hormonal (Baseline) Number Analyzed 21 participants 32 participants
77.0  (18.19) 73.6  (16.13)
Hormonal (Change from BL@Month 3) Number Analyzed 8 participants 9 participants
4.4  (16.35) 10.4  (24.62)
Hormonal (Change from BL@Month 6) Number Analyzed 3 participants 7 participants
1.7  (28.87) 10.0  (10.00)
Hormonal (Change from BL@Follow-up Month 3) Number Analyzed 0 participants 3 participants
8.3  (7.64)
10.Secondary Outcome
Title Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Hide Description The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classifies participants according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). ECOG PS: 0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5 = dead.
Time Frame Baseline, Treatment Visit 1, Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Follow-up Month 3, Follow-up Month 12, Follow-up Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis.
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description:
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Overall Number of Participants Analyzed 28 43
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 19 participants 33 participants
0.9  (0.81) 0.9  (0.61)
Change from BL@Treatment Visit 1 Number Analyzed 13 participants 28 participants
-0.2  (0.60) 0.0  (0.54)
Change from BL@Treatment Visit 2 Number Analyzed 16 participants 31 participants
-0.3  (0.60) -0.1  (0.63)
Change from BL@Treatment Visit 3 Number Analyzed 13 participants 19 participants
-0.2  (0.73) -0.2  (0.50)
Change from BL@Treatment Visit 4 Number Analyzed 9 participants 16 participants
-0.1  (0.93) -0.3  (0.48)
Change from BL@Follow-up Month 3 Number Analyzed 1 participants 0 participants
0.0 [1]   (NA)
Change from BL@Follow-up Month 12 Number Analyzed 0 participants 1 participants
-1.0 [1]   (NA)
Change from BL@Follow-up Month 15 Number Analyzed 0 participants 1 participants
0.0 [1]   (NA)
[1]
Only one participant analyzed
Time Frame Adverse events (AEs) were collected from informed consent signature through to 24 months after first 177Lu-PSMA-617 treatment therapy.
Adverse Event Reporting Description Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (Day 0) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
 
Arm/Group Title 177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Hide Arm/Group Description Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
All-Cause Mortality
177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/23 (13.04%)   3/41 (7.32%) 
Hide Serious Adverse Events
177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/23 (17.39%)   8/41 (19.51%) 
Blood and lymphatic system disorders     
Anaemia  1  0/23 (0.00%)  1/41 (2.44%) 
Thrombocytopenia  1  0/23 (0.00%)  1/41 (2.44%) 
Gastrointestinal disorders     
Abdominal pain  1  0/23 (0.00%)  1/41 (2.44%) 
Gastrointestinal haemorrhage  1  0/23 (0.00%)  1/41 (2.44%) 
General disorders     
Death  1  0/23 (0.00%)  1/41 (2.44%) 
Infections and infestations     
Pneumonia  1  0/23 (0.00%)  1/41 (2.44%) 
Injury, poisoning and procedural complications     
Subdural haematoma  1  1/23 (4.35%)  0/41 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoporosis  1  1/23 (4.35%)  0/41 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  0/23 (0.00%)  1/41 (2.44%) 
Metastases to central nervous system  1  2/23 (8.70%)  0/41 (0.00%) 
Metastases to meninges  1  0/23 (0.00%)  1/41 (2.44%) 
Renal and urinary disorders     
Acute kidney injury  1  0/23 (0.00%)  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  0/23 (0.00%)  1/41 (2.44%) 
1
Term from vocabulary, MedDRA (22.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
177Lu-PSMA-617 (6.0 GBq) 177Lu-PSMA-617 (7.4 GBq)
Affected / at Risk (%) Affected / at Risk (%)
Total   22/23 (95.65%)   38/41 (92.68%) 
Blood and lymphatic system disorders     
Anaemia  1  4/23 (17.39%)  3/41 (7.32%) 
Leukopenia  1  0/23 (0.00%)  1/41 (2.44%) 
Lymphadenopathy  1  1/23 (4.35%)  0/41 (0.00%) 
Lymphopenia  1  0/23 (0.00%)  1/41 (2.44%) 
Ear and labyrinth disorders     
Deafness  1  0/23 (0.00%)  1/41 (2.44%) 
Endocrine disorders     
Hypothyroidism  1  0/23 (0.00%)  1/41 (2.44%) 
Eye disorders     
Dry eye  1  1/23 (4.35%)  3/41 (7.32%) 
Lacrimation increased  1  0/23 (0.00%)  1/41 (2.44%) 
Gastrointestinal disorders     
Abdominal pain  1  1/23 (4.35%)  1/41 (2.44%) 
Constipation  1  6/23 (26.09%)  9/41 (21.95%) 
Diarrhoea  1  3/23 (13.04%)  13/41 (31.71%) 
Dry mouth  1  11/23 (47.83%)  26/41 (63.41%) 
Frequent bowel movements  1  0/23 (0.00%)  1/41 (2.44%) 
Hyperaesthesia teeth  1  1/23 (4.35%)  0/41 (0.00%) 
Lip dry  1  0/23 (0.00%)  1/41 (2.44%) 
Nausea  1  12/23 (52.17%)  18/41 (43.90%) 
Saliva altered  1  1/23 (4.35%)  0/41 (0.00%) 
Vomiting  1  4/23 (17.39%)  8/41 (19.51%) 
General disorders     
Asthenia  1  0/23 (0.00%)  1/41 (2.44%) 
Chest pain  1  1/23 (4.35%)  1/41 (2.44%) 
Fatigue  1  13/23 (56.52%)  21/41 (51.22%) 
Feeling hot  1  0/23 (0.00%)  1/41 (2.44%) 
Oedema peripheral  1  0/23 (0.00%)  1/41 (2.44%) 
Pain  1  3/23 (13.04%)  5/41 (12.20%) 
Pyrexia  1  0/23 (0.00%)  2/41 (4.88%) 
Infections and infestations     
Bronchitis  1  0/23 (0.00%)  1/41 (2.44%) 
Herpes zoster  1  1/23 (4.35%)  0/41 (0.00%) 
Urinary tract infection  1  0/23 (0.00%)  1/41 (2.44%) 
Investigations     
Blood lactate dehydrogenase increased  1  1/23 (4.35%)  0/41 (0.00%) 
Glomerular filtration rate decreased  1  1/23 (4.35%)  0/41 (0.00%) 
Weight decreased  1  0/23 (0.00%)  1/41 (2.44%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/23 (4.35%)  5/41 (12.20%) 
Dehydration  1  0/23 (0.00%)  1/41 (2.44%) 
Hyponatraemia  1  1/23 (4.35%)  1/41 (2.44%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/23 (13.04%)  2/41 (4.88%) 
Back pain  1  2/23 (8.70%)  1/41 (2.44%) 
Bone pain  1  1/23 (4.35%)  2/41 (4.88%) 
Musculoskeletal chest pain  1  0/23 (0.00%)  2/41 (4.88%) 
Musculoskeletal stiffness  1  0/23 (0.00%)  1/41 (2.44%) 
Neck pain  1  0/23 (0.00%)  1/41 (2.44%) 
Pain in extremity  1  1/23 (4.35%)  2/41 (4.88%) 
Nervous system disorders     
Dizziness  1  0/23 (0.00%)  2/41 (4.88%) 
Headache  1  2/23 (8.70%)  2/41 (4.88%) 
Parosmia  1  1/23 (4.35%)  0/41 (0.00%) 
Taste disorder  1  4/23 (17.39%)  7/41 (17.07%) 
Psychiatric disorders     
Depression  1  0/23 (0.00%)  1/41 (2.44%) 
Renal and urinary disorders     
Bladder pain  1  0/23 (0.00%)  1/41 (2.44%) 
Dysuria  1  1/23 (4.35%)  1/41 (2.44%) 
Pollakiuria  1  0/23 (0.00%)  1/41 (2.44%) 
Reproductive system and breast disorders     
Prostatic pain  1  0/23 (0.00%)  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/23 (0.00%)  3/41 (7.32%) 
Epistaxis  1  1/23 (4.35%)  0/41 (0.00%) 
Rhinorrhoea  1  0/23 (0.00%)  1/41 (2.44%) 
Wheezing  1  0/23 (0.00%)  1/41 (2.44%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  1/23 (4.35%)  0/41 (0.00%) 
Pain of skin  1  0/23 (0.00%)  1/41 (2.44%) 
Vascular disorders     
Haematoma  1  0/23 (0.00%)  2/41 (4.88%) 
1
Term from vocabulary, MedDRA (22.1)
Indicates events were collected by systematic assessment
The study began on 05-Jul-17 as an Investigator Initiated Trial and sponsorship was transferred to Endocyte on 01-Jun-18. Recruitment was stopped before the target sample size was achieved based on strategic considerations.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT03042312    
Other Study ID Numbers: PSMA-617-02
133661 ( Other Identifier: Original sponsor )
First Submitted: January 18, 2017
First Posted: February 3, 2017
Results First Submitted: January 14, 2021
Results First Posted: March 24, 2021
Last Update Posted: March 24, 2021