NCT03042312 (RESIST-PC) is a Phase 2 clinical trial of 177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer, sponsored by Endocyte.

Who is sponsoring NCT03042312?

NCT03042312 is sponsored by Endocyte.

What drugs are being tested in NCT03042312?

Interventions in NCT03042312: 177Lu-PSMA-617.

What condition does NCT03042312 study?

NCT03042312 studies Metastatic Castration Resistant Prostate Cancer.

Is NCT03042312 still recruiting?

NCT03042312 is currently terminated. Last updated 24 March 2021.

Are results published for NCT03042312?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-03-24 · How we verify

NCT03042312: RESIST-PC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Results posted Last updated 24 March 2021

What this trial tests

Phase 2 trial testing 177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer in 71 participants. Terminated before completion.

Timeline

12 July 2017

Primary endpoint
15 January 2020

15 January 2020

Quick facts

Lead sponsor	Endocyte
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	12 July 2017
Primary completion	15 January 2020
Estimated completion	15 January 2020
Sites	2 locations across United States

Drugs / interventions tested

177Lu-PSMA-617 — full drug profile →

Conditions studied

Metastatic Castration Resistant Prostate Cancer — all drugs for Metastatic Castration Resistant Prostate Cancer →

Sponsor

Endocyte — full company profile →

Who can join

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

Results — posted to ClinicalTrials.gov

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

Number of Participants With Treatment Emergent Adverse Events Primary · 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

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.

Treatment-Emergent Adverse Events (TEAEs)

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	22
177Lu-PSMA-617 (7.4 GBq)	39

Serious TEAEs

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	4
177Lu-PSMA-617 (7.4 GBq)	8

Drug-related TEAEs

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	20
177Lu-PSMA-617 (7.4 GBq)	37

Serious drug-related TEAEs

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	1
177Lu-PSMA-617 (7.4 GBq)	4

TEAEs leading to reduction of Lu-PSMA-617

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	2

TEAEs leading to discontinuation of Lu-PSMA-617

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	1

TEAEs leading to death

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	2
177Lu-PSMA-617 (7.4 GBq)	1

Number of Participants Achieving PSA Response at Week 12 Primary · Week 12

PSA response was defined as the proportion of patients who had a \>= 50% decrease in PSA from Baseline at Week 12.

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	5
177Lu-PSMA-617 (7.4 GBq)	8
177Lu-PSMA-617 (6.0 GBq)	6
177Lu-PSMA-617 (7.4 GBq)	6
177Lu-PSMA-617 (6.0 GBq)	3
177Lu-PSMA-617 (7.4 GBq)	11

Percent Change in PSA From Baseline to Week 12 Secondary · Week 12

Percent change in PSA from Baseline to Week 12 was reported for participants who had a baseline and a week 12 valid assessments.

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	-22.54	± 75.513
177Lu-PSMA-617 (7.4 GBq)	92.15	± 301.932

Maximum Percent Change in PSA Response Secondary · Every 6 weeks during the treatment and every 3 (+/- 1) months after last treatment until reaching endpoint or 24 months after the first treatment

Maximal baseline to follow-up PSA decline, at any time during or after therapy was evaluated in both treatment groups.

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	-3.63	± 95.394
177Lu-PSMA-617 (7.4 GBq)	8.75	± 132.954

PSA Progression and Death Events Secondary · 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

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.

Deaths without PSA progression

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	2
177Lu-PSMA-617 (7.4 GBq)	2

Participants with PSA progression, but who did not die

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	11
177Lu-PSMA-617 (7.4 GBq)	17

RECIST 1.1 Overall Response by Follow-up Assessment Visit Secondary · 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.

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

Follow-up 1

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	1
177Lu-PSMA-617 (7.4 GBq)	1
177Lu-PSMA-617 (6.0 GBq)	3
177Lu-PSMA-617 (7.4 GBq)	4
177Lu-PSMA-617 (6.0 GBq)	1
177Lu-PSMA-617 (7.4 GBq)	7
177Lu-PSMA-617 (6.0 GBq)	6
177Lu-PSMA-617 (7.4 GBq)	9

Follow-up 2

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	3
177Lu-PSMA-617 (7.4 GBq)	1
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	3
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	1
177Lu-PSMA-617 (7.4 GBq)	1

Follow-up 3

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	1
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	1
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0

Follow-up 4

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	1
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0

RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit Secondary · 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.

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

Follow-up 1

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	17.9
177Lu-PSMA-617 (7.4 GBq)	27.9

Follow-up 2

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	10.7
177Lu-PSMA-617 (7.4 GBq)	9.3

Follow-up 3

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	3.6
177Lu-PSMA-617 (7.4 GBq)	2.3

Follow-up 4

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	3.6

Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit Secondary · 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

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.

Screening

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	1
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0

Week 8

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	1
177Lu-PSMA-617 (7.4 GBq)	3
177Lu-PSMA-617 (6.0 GBq)	1
177Lu-PSMA-617 (7.4 GBq)	2
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	1

Week 10

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	3
177Lu-PSMA-617 (6.0 GBq)	2
177Lu-PSMA-617 (7.4 GBq)	1
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0

Week 16

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	2
177Lu-PSMA-617 (6.0 GBq)	2
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0

Week 18

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	3
177Lu-PSMA-617 (6.0 GBq)	1
177Lu-PSMA-617 (7.4 GBq)	0

Week 22

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	1
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0

Week 24

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	1
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0

Follow-up Week 4

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	0
177Lu-PSMA-617 (6.0 GBq)	0
177Lu-PSMA-617 (7.4 GBq)	1

Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Secondary · Baseline, Month 3, Month 6, Follow-up Month 3

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 domai

Urinary Incontinence (Baseline)

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	78.3	± 26.87
177Lu-PSMA-617 (7.4 GBq)	77.4	± 24.64

Urinary Incontinence (Change from BL@Month 3)

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	4.9	± 12.57
177Lu-PSMA-617 (7.4 GBq)	9.7	± 20.88

Urinary Incontinence (Change from BL@Month 6)

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	11.1	± 19.20
177Lu-PSMA-617 (7.4 GBq)	-6.3	± 14.66

Urinary Incontinence (Change from BL@Follow-up Month 3)

Group	Value	95% CI
177Lu-PSMA-617 (7.4 GBq)	-2.1	± 9.55

Urinary Irritative/Obstructive (Baseline)

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	83.2	± 20.73
177Lu-PSMA-617 (7.4 GBq)	84.8	± 19.13

Urinary Irritative/Obstructive (Change from BL@Month 3)

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	17.9	± 25.37
177Lu-PSMA-617 (7.4 GBq)	-1.4	± 4.17

Urinary Irritative/Obstructive (Change from BL@Month 6)

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	2.1	± 9.55
177Lu-PSMA-617 (7.4 GBq)	6.3	± 8.84

Urinary Irritative/Obstructive (Change from BL@Follow-up Month 3)

Group	Value	95% CI
177Lu-PSMA-617 (7.4 GBq)	8.3	± 9.55

Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Secondary · 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

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 l

Baseline

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0.9	± 0.81
177Lu-PSMA-617 (7.4 GBq)	0.9	± 0.61

Change from BL@Treatment Visit 1

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	-0.2	± 0.60
177Lu-PSMA-617 (7.4 GBq)	0.0	± 0.54

Change from BL@Treatment Visit 2

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	-0.3	± 0.60
177Lu-PSMA-617 (7.4 GBq)	-0.1	± 0.63

Change from BL@Treatment Visit 3

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	-0.2	± 0.73
177Lu-PSMA-617 (7.4 GBq)	-0.2	± 0.50

Change from BL@Treatment Visit 4

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	-0.1	± 0.93
177Lu-PSMA-617 (7.4 GBq)	-0.3	± 0.48

Change from BL@Follow-up Month 3

Group	Value	95% CI
177Lu-PSMA-617 (6.0 GBq)	0.0	± NA

Change from BL@Follow-up Month 12

Group	Value	95% CI
177Lu-PSMA-617 (7.4 GBq)	-1.0	± NA

Change from BL@Follow-up Month 15

Group	Value	95% CI
177Lu-PSMA-617 (7.4 GBq)	0.0	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) were collected from informed consent signature through to 24 months after first 177Lu-PSMA-617 treatment therapy.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

177Lu-PSMA-617 (6.0 GBq)

Serious: 4/23 (17%)

Deaths: 3/23

177Lu-PSMA-617 (7.4 GBq)

Serious: 8/41 (20%)

Deaths: 3/41

Serious adverse events (13 terms)

Reaction	System	177Lu-PSMA-617 (6.0 GBq)	177Lu-PSMA-617 (7.4 GBq)
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Death	General disorders	—	—
Pneumonia	Infections and infestations	—	—
Subdural haematoma	Injury, poisoning and procedural complications	—	—
Osteoporosis	Musculoskeletal and connective tissue disorders	—	—
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (57 terms — click to expand)

Reaction	System	177Lu-PSMA-617 (6.0 GBq)	177Lu-PSMA-617 (7.4 GBq)
Dry mouth	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Taste disorder	Nervous system disorders	—	—
Pain	General disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Dry eye	Eye disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Pyrexia	General disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Haematoma	Vascular disorders	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—
Deafness	Ear and labyrinth disorders	—	—
Hypothyroidism	Endocrine disorders	—	—
Lacrimation increased	Eye disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Frequent bowel movements	Gastrointestinal disorders	—	—
Hyperaesthesia teeth	Gastrointestinal disorders	—	—
Lip dry	Gastrointestinal disorders	—	—
Saliva altered	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Chest pain	General disorders	—	—
Feeling hot	General disorders	—	—
Oedema peripheral	General disorders	—	—
Bronchitis	Infections and infestations	—	—
Herpes zoster	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Blood lactate dehydrogenase increased	Investigations	—	—

Most-reported serious reactions: Metastases to central nervous system, Anaemia, Thrombocytopenia, Abdominal pain, Gastrointestinal haemorrhage, Death, Pneumonia, Subdural haematoma.

Data from ClinicalTrials.gov NCT03042312 adverse events section.

Sponsor's own description

This was an open-label, multicenter, prospective trial to assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Nomograms to predict outcomes after 177Lu-PSMA therapy in men with metastatic castration-resistant prostate cancer: an international, multicentre, retrospective study.
Gafita A, Calais J, Grogan TR, Hadaschik B, et al · · 2021 · cited 189× · PMID 34246328 · DOI 10.1016/s1470-2045(21)00274-6
Radiotheranostics: a roadmap for future development.
Herrmann K, Schwaiger M, Lewis JS, Solomon SB, et al · · 2020 · cited 185× · PMID 32135118 · DOI 10.1016/s1470-2045(19)30821-6
[177Lu]Lu-PSMA-617 (PluvictoTM): The First FDA-Approved Radiotherapeutical for Treatment of Prostate Cancer.
Hennrich U, Eder M. · · 2022 · cited 174× · PMID 36297404 · DOI 10.3390/ph15101292
Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study.
Gafita A, Rauscher I, Weber M, Hadaschik B, et al · · 2022 · cited 131× · PMID 35422442 · DOI 10.2967/jnumed.121.263072
Third-line treatment and 177Lu-PSMA radioligand therapy of metastatic castration-resistant prostate cancer: a systematic review.
von Eyben FE, Roviello G, Kiljunen T, Uprimny C, et al · · 2018 · cited 113× · PMID 29247284 · DOI 10.1007/s00259-017-3895-x
Status of PSMA-targeted radioligand therapy in prostate cancer: current data and future trials.
Jang A, Kendi AT, Sartor O. · · 2023 · cited 63× · PMID 36895851 · DOI 10.1177/17588359231157632
Lutetium Lu 177 Vipivotide Tetraxetan: First Approval.
Keam SJ. · · 2022 · cited 62× · PMID 35553387 · DOI 10.1007/s40291-022-00594-2
PSMA-Targeting Imaging and Theranostic Agents-Current Status and Future Perspective.
Debnath S, Zhou N, McLaughlin M, Rice S, et al · · 2022 · cited 54× · PMID 35163083 · DOI 10.3390/ijms23031158

Verify or expand the search:

Other trials of 177Lu-PSMA-617

Trials testing the same drug.

NCT07145177 — 177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer · Phase 1 · recruiting
NCT06783348 — Radiopharmaceutical Treatment of Advanced Kidney Cancer · Phase 2 · not yet recruiting
NCT07025512 — 177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia · Phase 2 · suspended
NCT06964958 — 177LuPSMA in Renal Cell Carcinoma · Phase 2 · active not recruiting
NCT06461689 — Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant · completed

Other recruiting trials for Metastatic Castration Resistant Prostate Cancer

Currently open trials in the same condition.

NCT07093801 — Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer · recruiting
NCT06830850 — A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With · Phase 1 · recruiting
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NCT05219500 — Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate C · Phase 2 · active not recruiting
NCT04729114 — A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer · Phase 1 · recruiting

Other Endocyte trials

Trials by the same sponsor.

NCT04597411 — Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer · Phase 1 · recruiting
NCT03511664 — Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer · Phase 3 · completed
NCT03011320 — An Exploratory Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Surgery · Phase 1 · completed
NCT01170650 — Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED) · Phase 3 · terminated
NCT01002924 — Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010) · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03042312 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Endocyte
Last refreshed: 24 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03042312.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing