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Active, not recruitingNCT04647526SPLASHUpdated Jan 13, 2026Results posted

Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

A Phase 3 interventional study of [Lu-177]-PNT2002 and Abiraterone in Metastatic Castration-Resistant Prostate Cancer, sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company. Active, not recruiting at 54 sites in 6 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
455
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of [Lu-177]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).

Read the detailed description

The primary objective of the study is to determine the efficacy of [Lu-177]-PNT2002 ([Lu-177]-PSMA-I\&T) versus abiraterone or enzalutamide in delaying radiographic progression in patients with mCRPC.

The study consists of 3 phases: Dosimetry, Randomized Treatment, and Long term Follow up.

The study will commence with a 25-patient safety and dosimetry lead-in (Part 1) and proceed to a randomization treatment phase in approximately 390 patients (Part 2). Patients in Part 2 will be randomized in a 2:1 ratio to receive either [Lu-177]-PNT2002 (Arm A), or enzalutamide or abiraterone (Arm B). Patients in Arm B who experience radiographic progression per central review and meet protocol defined eligibility, may crossover to receive [Lu-177]-PNT2002. After final overall survival (OS) analysis, all patients will continue to be followed through Continued Access, including long-term follow-up (LTFU) for at least 5 years from the first therapeutic dose, death, or loss to follow up (Part 3).

Only patients that meet PSMA PET avidity criteria per central review will be eligible for this study.

02

Conditions studied

  • Metastatic Castration-Resistant Prostate Cancer

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Keywords

  • PSMA
  • mCRPC
  • Prostate cancer
  • 177Lu-PSMA
  • radioligand therapy
  • PSMA-I&T
  • SPLASH
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 455 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Male aged 18 years or older.
  2. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
  3. Ineligible or averse to chemotherapeutic treatment options.

  4. Patients must have progressive mCRPC at the time of consent based on at least 1 of the following criteria:

    1. Serum/plasma PSA progression defined as increase in PSA greater than 25% and >2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart.
    2. Soft-tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or a new lesion.
    3. Progression of bone disease defined as the appearance of two or more new lesions by bone scan.
  5. Progression on previous treatment with one ARAT (abiraterone or enzalutamide or darolutamide or apalutamide) in either the CSPC or CRPC setting.
  6. PSMA-PET scan (i.e., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by the sponsor's central reader.
  7. Castrate circulating testosterone levels (\<1.7 nmol/L or \<50 ng/dL).

  8. Adequate organ function, independent of transfusion:

    1. Bone marrow reserve:

      • i. White blood cell (WBC) count ≥2.5 × 10\^9/L OR absolute neutrophil count (ANC) ≥1.5 × 10\^9/L.
      • ii. Platelets ≥100 × 10\^9/L.
      • iii. Hemoglobin ≥8 mmol/L.

    2. Liver function:

      • i. Total bilirubin ≤1.5 × institutional upper limit of normal (ULN). For patients with known Gilbert's syndrome, ≤3 × ULN is permitted.
      • ii. ALT or AST ≤3.0× ULN.

    3. Renal function:

      • i. Serum/plasma creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula (for patients in France, serum/plasma creatinine ≤1.5 × ULN or CrCl ≥60 mL/min based on Cockcroft-Gault formula).
    4. Albumin ≥30 g/L.
  9. Human immunodeficiency virus-infected patients who are healthy and have a low risk of acquired immunodeficiency syndrome-related outcomes are included in this trial.
  10. For patients who have partners who are pregnant or of childbearing potential: a condom is required along with a highly effective contraceptive method during the study and for 6 months after last study drug administration. Such methods deemed highly effective include a) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, b) progestogen-only hormonal contraception associated with inhibition of ovulation, c) intrauterine device (IUD), d) intrauterine hormone-releasing system (IUS), e) bilateral tubal occlusion, f) vasectomy, g) true sexual abstinence: when this is in line with the preferred and usual lifestyle of the subject [periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of abstinence].
  11. Willing to initiate ARAT therapy (either enzalutamide or abiraterone), pre-specified by investigator, if randomized to Treatment Arm B.
  12. ECOG performance status 0 to 1.
  13. Willing and able to comply with all study requirements and treatments (including 177Lu PNT2002) as well as the timing and nature of required assessments.
  14. Signed informed consent.

Exclusion criteria

Exclusion Criteria:

Patients are excluded from the study if any of the following criteria apply:

  1. If noted in pathology report, prostate cancer with known significant (>10% present in cells) sarcomatoid or spindle cell or neuroendocrine components. Any small cell component in the cancer should result in exclusion.
  2. Prior treatment for prostate cancer ≤28 days prior to randomization, with the exclusion of first-line local external beam, ARAT, luteinizing hormone-releasing hormone (LHRH) therapy, or non-radioactive bone-targeted agents.
  3. Any prior cytotoxic chemotherapy for CRPC (e.g., cabazitaxel or docetaxel); chemotherapy for hormone-sensitive prostate cancer (HSPC) is allowed if the last dose was administered >1 year prior to consent.
  4. Prior treatment with systemic radionuclides (e.g. radium-223, rhenium-186, strontium 89).
  5. Prior immuno-therapy, except for sipuleucel-T.
  6. Prior PSMA-targeted radioligand therapy, e.g., Lu-177-PSMA-617, I 131-1095.
  7. Prior poly ADP ribose polymerase (PARP) inhibitor for prostate cancer.
  8. Patients who progressed on 2 or more lines of ARATs.
  9. Patients receiving bone-targeted therapy (e.g. denosumab, zoledronic acid) not on stable doses for at least 4 weeks prior to randomization.
  10. Administration of an investigational agent ≤60 days or 5 half-lives, whichever is shorter, prior to randomization.
  11. Major surgery ≤30 days prior to randomization.
  12. Estimated life expectancy \<6 months as assessed by the principal investigator.
  13. Presence of liver metastases >1 cm on abdominal imaging.
  14. A superscan on bone scan defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity.
  15. Dose escalation or initiation of opioids for cancer-related pain ≤30 days prior to consent up to and including randomization.
  16. Known presence of central nervous system metastases.

  17. Contraindications to the use of planned ARAT therapy, [Ga-68]-PSMA-11, [F-18]-DCFPyL or [Lu-177]-PNT2002 therapy, including but not limited to the following:

    • Hypersensitivity to [Ga-68]-PSMA-11, [F-18]-DCFPyL or [Lu-177]-PNT2002 excipients (Diethylenetriaminepentaacetic acid (DTPA), Sodium ascorbate, Lascorbic acid, Sodium gentisate, HCl, Sodium hydroxide).
    • Recent myocardial infarction or arterial thrombotic events (in the past 6 months) or unstable angina (in the past 3 months), bradycardia or left ventricular ejection fraction measurement of \< 50%.
    • History of seizures in patients planned to receive enzalutamide.
  18. Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer.
  19. Concurrent illness that may jeopardize the patient's ability to undergo study procedures.
  20. Serious psychological, familial, sociological, or geographical condition that might hamper compliance with the study protocol and follow-up schedule. Patients that travel need to be capable of repeated visits even if they are on the control arm.
  21. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
  22. Concurrent serious (as determined by the investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure (see 12.1 Appendix 1), unstable ischemia, uncontrolled symptomatic arrhythmia, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
455 participants (actual)

Study arms

  • Experimental
    Lead-in Dosimetry Phase: [Lu-177]-PNT2002

    Participants received 6.8 gigabecquerels (GBq) (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.

    Drug: [Lu-177]-PNT2002

  • Experimental
    Randomization Phase: [Lu-177]-PNT2002 (Arm A)

    Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.

    Drug: [Lu-177]-PNT2002

  • Active comparator
    Randomization Phase: Abiraterone or Enzalutamide (Arm B)

    Participants received either of below treatments until radiographic progression. * Enzalutamide 160 milligram (mg) orally once daily (or) * Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily. Participants who experienced radiographic progression per Blinded Independent Central Review (BICR) (or after final overall survival (OS), per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled adverse events (AEs) were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.

    Drug: [Lu-177]-PNT2002 · Drug: Abiraterone · Drug: Enzalutamide

  • Experimental
    Pharmacokinetic (PK) Extension Phase: [Lu-177]-PNT2002

    Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.

    Drug: [Lu-177]-PNT2002

Interventions

  • Drug[Lu-177]-PNT2002

    Participants randomized to Arm A will receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 every 8 weeks for 4 cycles

    Also known as: [Lu-177]-PSMA-I&T, LY4187525

  • DrugAbiraterone

    Abiraterone (1000 mg orally once daily with: 5 mg twice daily prednisone or 0.5 mg once daily dexamethasone)

  • DrugEnzalutamide

    Enzalutamide (160 mg orally once daily)

06

What researchers measure

Primary outcomes

  1. Randomization Phase: Radiographic Progression-Free Survival (rPFS)

    * rPFS, as assessed by blinded independent central review (BICR), is the time from the randomization date to progression on soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or confirmed progression on bone lesions by Prostate Cancer Working Group 3 (PCWG3) criteria, or death from any cause. * The date of disease progression is the date of the scan for the first objectively documented progressive disease (PD) per RECIST v1.1 or PCWG3. PD is defined as a ≥20% increase in the sum of the diameters of target lesions (≥5 mm absolute), with reference being the smallest sum in the study, or unequivocal progression of non-target lesions, or appearance of new lesions. * Participants who do not progress, including those who started new anticancer therapy, withdrew from the study, or were lost to follow-up without disease progression, were censored at the last valid assessment for RECIST v1.1 or PCWG3.

    Time frame: From the randomization date to the first documented progressive disease or death from any cause (up to 23 months)

Secondary outcomes

  1. Randomization Phase: Percentage of Participants With Objective Response Rate (ORR)

    * ORR, as assessed by BICR, is the best confirmed overall tumor response of complete response (CR) or partial response (PR) as per RECIST v1.1 ( in the absence of confirmed progression on bone scan assessed by PCWG3). * CR is a disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). * PR is at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), without progression of non-target lesions or appearance of new lesions.

    Time frame: Randomization until measured progressive disease (up to 23 months)

  2. Randomization Phase: Duration of Response

    Duration of Response, as assessed by BICR, is the time from the date of first documented confirmed CR or PR as per RECIST v1.1 (in the absence of confirmed progression on bone scan assessed by PCWG3) to the date of first documented radiographic progression or death in the absence of progression. Participants who have attained CR or PR as the best overall response, did not have progressive disease, and did not die will be censored.

    Time frame: From the date of first CR or PR to disease progression or death (up to 16.3 months)

  3. Randomization Phase: Percentage of Participants With Prostate-Specific Antigen (PSA) Response Rate

    The PSA response rate, as per the PCWG3 criteria, is the percentage of participants achieving a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second PSA assessment conducted at least 3 weeks later.

    Time frame: From the randomization up to 23 months

  4. Randomization Phase: Biochemical Progression-Free Survival (bPFS)

    bPFS is the time from the date of randomization to the date of the first PSA increase from baseline ≥25% and ≥2 nanograms per milliliter (ng/mL) above nadir confirmed by a second PSA measurement defining progression ≥3 weeks later, as per PCWG3, or death from any cause in the absence of progression. Participants who do not progress or die including those who withdraw from the study or are lost to follow-up will be censored at the time of last valid PSA measurement.

    Time frame: From the randomization up to 23 months

  5. Overall Survival

    Time from the date of randomization until death due to any cause.

    Time frame: 5 years

07

Results

Posted Jan 13, 2026

Participant flow

The study includes: * Lead-in dosimetry phase to evaluate the dosimetry of \[Lu-177\]-PNT2002 across standard organs such as the kidneys, salivary and lacrimal glands. * Randomization phase to compare the efficacy of \[Lu-177\]-PNT2002 versus enzalutamide or abiraterone (control arm). Additionally, there is a pharmacokinetic (PK) extension phase, in which participants were enrolled at selected sites in the United States and Canada for PK assessments of \[Lu-177\]-PNT2002.

Participant flow — Overall Study
MilestoneLead-in Dosimetry Phase: [Lu-177]-PNT2002Randomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)PK Extension Phase: [Lu-177]-PNT2002
Started2727613616
Intent-to-treat analysis (itt) set02761360
Participants on arm b treatment who crossed over to [lu-177]-pnt200200770
Safety analysis set2726913015
Completed0000
Not completed2727613616
Withdrew: Death1376320
Withdrew: Lost to follow-up1010
Withdrew: Withdrawal by subject41581
Withdrew: Incorrect enrollment0110
Withdrew: Physician decision0110
Withdrew: Ongoing91839315

Outcome measures

PrimaryRandomization Phase: Radiographic Progression-Free Survival (rPFS)

* rPFS, as assessed by blinded independent central review (BICR), is the time from the randomization date to progression on soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or confirmed progression on bone lesions by Prostate Cancer Working Group 3 (PCWG3) criteria, or death from any cause. * The date of disease progression is the date of the scan for the first objectively documented progressive disease (PD) per RECIST v1.1 or PCWG3. PD is defined as a ≥20% increase in the sum of the diameters of target lesions (≥5 mm absolute), with reference being the smallest sum in the study, or unequivocal progression of non-target lesions, or appearance of new lesions. * Participants who do not progress, including those who started new anticancer therapy, withdrew from the study, or were lost to follow-up without disease progression, were censored at the last valid assessment for RECIST v1.1 or PCWG3.

Time frame:
From the randomization date to the first documented progressive disease or death from any cause (up to 23 months)
Reported as:
Median · months
Randomization Phase: Radiographic Progression-Free Survival (rPFS)
monthsRandomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)
Randomization Phase: Radiographic Progression-Free Survival (rPFS)9.5 (7.4 to 10.0)6.0 (4.7 to 7.9)
Statistical analysis
  • Randomization Phase: [Lu-177]-PNT2002 (Arm A) vs Randomization Phase: Abiraterone or Enzalutamide (Arm B) · Log Rank · p = 0.0088 · Hazard ratio (hr): 0.71 · 95% CI 0.55 to 0.92
SecondaryRandomization Phase: Percentage of Participants With Objective Response Rate (ORR)

* ORR, as assessed by BICR, is the best confirmed overall tumor response of complete response (CR) or partial response (PR) as per RECIST v1.1 ( in the absence of confirmed progression on bone scan assessed by PCWG3). * CR is a disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). * PR is at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), without progression of non-target lesions or appearance of new lesions.

Time frame:
Randomization until measured progressive disease (up to 23 months)
Reported as:
Number · percentage of participants
Randomization Phase: Percentage of Participants With Objective Response Rate (ORR)
percentage of participantsRandomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)
Randomization Phase: Percentage of Participants With Objective Response Rate (ORR)32.0 (22.9 to 42.2)8.0 (2.2 to 19.2)
SecondaryRandomization Phase: Duration of Response

Duration of Response, as assessed by BICR, is the time from the date of first documented confirmed CR or PR as per RECIST v1.1 (in the absence of confirmed progression on bone scan assessed by PCWG3) to the date of first documented radiographic progression or death in the absence of progression. Participants who have attained CR or PR as the best overall response, did not have progressive disease, and did not die will be censored.

Time frame:
From the date of first CR or PR to disease progression or death (up to 16.3 months)
Reported as:
Median · months
Randomization Phase: Duration of Response
monthsRandomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)
Randomization Phase: Duration of Response9.4 (7.6 to 15.0)8.3 (4.0 to NA)
SecondaryRandomization Phase: Percentage of Participants With Prostate-Specific Antigen (PSA) Response Rate

The PSA response rate, as per the PCWG3 criteria, is the percentage of participants achieving a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second PSA assessment conducted at least 3 weeks later.

Time frame:
From the randomization up to 23 months
Reported as:
Number · percentage of participants
Randomization Phase: Percentage of Participants With Prostate-Specific Antigen (PSA) Response Rate
percentage of participantsRandomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)
Randomization Phase: Percentage of Participants With Prostate-Specific Antigen (PSA) Response Rate30.1 (24.7 to 35.9)12.5 (7.5 to 19.3)
SecondaryRandomization Phase: Biochemical Progression-Free Survival (bPFS)

bPFS is the time from the date of randomization to the date of the first PSA increase from baseline ≥25% and ≥2 nanograms per milliliter (ng/mL) above nadir confirmed by a second PSA measurement defining progression ≥3 weeks later, as per PCWG3, or death from any cause in the absence of progression. Participants who do not progress or die including those who withdraw from the study or are lost to follow-up will be censored at the time of last valid PSA measurement.

Time frame:
From the randomization up to 23 months
Reported as:
Median · months
Randomization Phase: Biochemical Progression-Free Survival (bPFS)
monthsRandomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)
Randomization Phase: Biochemical Progression-Free Survival (bPFS)7.0 (4.8 to 9.9)3.9 (3.5 to 4.3)
SecondaryOverall Survival

Time from the date of randomization until death due to any cause.

Time frame:
5 years

Results for this outcome have not been posted.

Adverse events

Collected over Baseline up to 26 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dosimetry Phase: [Lu-177]-PNT200213/27 (48.1%)6/27 (22.2%)24/27 (88.9%)
Randomization Phase: [Lu-177]-PNT2002 (Arm A)76/276 (27.5%)47/269 (17.5%)259/269 (96.3%)
Randomization Phase: Abiraterone or Enzalutamide (Arm B) / Abiraterone or Enzalutamide32/136 (23.5%)30/130 (23.1%)117/130 (90%)
Randomization Phase: Abiraterone or Enzalutamide (Arm B) / [Lu-177]-PNT200212/77 (15.6%)14/77 (18.2%)59/77 (76.6%)
PK Extension Phase: [Lu-177]-PNT20020/16 (0%)2/15 (13.3%)14/15 (93.3%)
Most frequent serious events
Showing 10 of 101
Most frequent serious events
EventDosimetry Phase: [Lu-177]-PNT2002Randomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B) / Abiraterone or EnzalutamideRandomization Phase: Abiraterone or Enzalutamide (Arm B) / [Lu-177]-PNT2002PK Extension Phase: [Lu-177]-PNT2002
Acute kidney injuryRenal and urinary disorders2/276/2690/1300/770/15
HaematuriaRenal and urinary disorders2/271/2692/1300/770/15
Pathological fractureMusculoskeletal and connective tissue disorders0/271/2692/1301/771/15
Urothelium erosionRenal and urinary disorders0/270/2690/1300/771/15
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/270/2691/1303/770/15
Disseminated intravascular coagulationBlood and lymphatic system disorders1/271/2690/1300/770/15
Abdominal painGastrointestinal disorders1/271/2691/1300/770/15
Large intestinal obstructionGastrointestinal disorders1/270/2690/1300/770/15
AstheniaGeneral disorders1/270/2690/1300/770/15
PyrexiaGeneral disorders1/270/2690/1300/770/15
Most frequent other events
Showing 10 of 87
Most frequent other events
EventDosimetry Phase: [Lu-177]-PNT2002Randomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B) / Abiraterone or EnzalutamideRandomization Phase: Abiraterone or Enzalutamide (Arm B) / [Lu-177]-PNT2002PK Extension Phase: [Lu-177]-PNT2002
FatigueGeneral disorders8/27144/26952/13024/777/15
Dry mouthGastrointestinal disorders7/27100/2692/13019/775/15
NauseaGastrointestinal disorders6/2784/26925/13017/770/15
ArthralgiaMusculoskeletal and connective tissue disorders4/2775/26935/13015/771/15
AnaemiaBlood and lymphatic system disorders6/2748/26913/13014/774/15
Lymphocyte count decreasedInvestigations0/278/2691/1300/774/15
Back painMusculoskeletal and connective tissue disorders4/2756/26928/1308/772/15
ConstipationGastrointestinal disorders2/2754/26923/1303/771/15
ThrombocytopeniaBlood and lymphatic system disorders2/278/2691/1302/773/15
DiarrhoeaGastrointestinal disorders2/2740/26913/1306/773/15

Baseline characteristics

All participants in the study.

Age, Categorical
Age, Categorical(Participants)Lead-in Dosimetry Phase: [Lu-177]-PNT2002Randomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)PK Extension Phase: [Lu-177]-PNT2002Total
<=18 years00000
Between 18 and 65 years75227086
>=65 years2022410916369
Sex: Female, Male
Sex: Female, Male(Participants)Lead-in Dosimetry Phase: [Lu-177]-PNT2002Randomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)PK Extension Phase: [Lu-177]-PNT2002Total
Female00000
Male2727613616455
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lead-in Dosimetry Phase: [Lu-177]-PNT2002Randomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)PK Extension Phase: [Lu-177]-PNT2002Total
Hispanic or Latino12519
Not Hispanic or Latino2626212915432
Unknown or Not Reported0122014
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Lead-in Dosimetry Phase: [Lu-177]-PNT2002Randomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)PK Extension Phase: [Lu-177]-PNT2002Total
American Indian or Alaska Native00000
Asian0112013
Native Hawaiian or Other Pacific Islander00000
Black or African American4328145
White2321511215365
More than one race02204
Unknown or Not Reported01612028
Region of Enrollment
Region of Enrollment(Participants)Lead-in Dosimetry Phase: [Lu-177]-PNT2002Randomization Phase: [Lu-177]-PNT2002 (Arm A)Randomization Phase: Abiraterone or Enzalutamide (Arm B)PK Extension Phase: [Lu-177]-PNT2002Total
Canada1278421133
Netherlands0116017
Sweden03508
United States151496515244
United Kingdom0103013
France02515040
08

Study locations

54 sites
  • Arizona Institute of Urology (AIU) - Tucson
    Tucson, Arizona 85704, United States
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    Los Angeles, California 90048, United States
  • VA Greater Los Angeles Healthcare System
    Los Angeles, California 90073, United States
  • University of California Los Angeles, Nuclear Medicine Clinic
    Los Angeles, California 90095, United States
  • Hoag Memorial Hospital Presbyterian
    Newport Beach, California 92663, United States
  • UC Irvine Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • Stanford Cancer Institute
    Palo Alto, California 94305, United States
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • H. Lee Moffitt Cancer Center & Research Institute
    Tampa, Florida 33612, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • University of Kentucky Chandler Medical Center
    Lexington, Kentucky 40536, United States
  • Tulane University Medical Center
    New Orleans, Louisiana 70112, United States
  • University of Maryland Greenebaum Cancer Center
    Baltimore, Maryland 21201, United States
  • Chesapeake Urology Associates (CUA) P.A.
    Towson, Maryland 21204, United States
  • University of Michigan Hospitals
    Ann Arbor, Michigan 48109, United States
  • Karmanos Cancer Center
    Detroit, Michigan 48201, United States
  • VA St. Louis Health Care System
    St Louis, Missouri 63106, United States
  • Saint Louis University Hospital
    St Louis, Missouri 63110, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Urology Cancer Center, PC
    Omaha, Nebraska 68130, United States
  • Astera Cancer Care
    East Brunswick, New Jersey 08816, United States
  • New Mexico Oncology Hematology Consultants Ltd., New Mexico Cancer Center
    Albuquerque, New Mexico 87109, United States
  • New York Presbyterian Hospital/Weill Cornell Medical Center
    New York, New York 10065, United States
  • Tri-State Urologic Services
    Cincinnati, Ohio 45212, United States
  • Greater Dayton Cancer Center
    Kettering, Ohio 45409, United States
  • Perelman Center for Advanced Medicine
    Philadelphia, Pennsylvania 19104, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Carolina Urologic Research Center
    Myrtle Beach, South Carolina 29572, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232, United States
  • Dallas VA Medical Center, Nuclear Medicine Service
    Dallas, Texas 75216, United States
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Excel Diagnostics & Nuclear Oncology Center
    Houston, Texas 77402, United States
  • Swedish Cancer Institute Research
    Seattle, Washington 98104, United States
  • BC Cancer - Vancouver
    Vancouver, British Columbia V5Z 4E6, Canada
  • Nova Scotia Health Authority
    Halifax, Nova Scotia B3H 2Y9, Canada
  • London Health Sciences Center - Victoria Hospital
    London, Ontario N6A 5W9, Canada
  • Sunnybrook Research Institute, Odette Cancer Center
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
  • CHUM - University Hospital of Montreal
    Montreal, Quebec H2X 3E4, Canada
  • Jewish General Hospital
    Montreal, Quebec H3T 1E2, Canada
  • CHU of Quebec - Laval University
    Québec, Quebec G1R 2J6, Canada
  • Center Jean Perrin, Department of Medical Oncology
    Clermont-Ferrand, 63011, France
  • Claude Huriez Hospital
    Lille, 59037, France
  • Leon Berard Center
    Lyon, 69373, France
  • La Timone Hospital, Nuclear Medicine Department
    Marseille, 13385, France
  • Montpellier Cancer Institute, Department of Nuclear Medicine
    Montpellier, 34298, France
  • Tenon Hospital, Department of Medical Oncology
    Paris, 75020, France
  • St. Antonius Hospital
    Nieuwegein, Netherlands
  • Radboud University Medical Center (Radboudumc)
    Nijmegen, Netherlands
  • Erasmus University Medical Center Rotterdam
    Rotterdam, 3015 GD, Netherlands
  • Sahlgrenska University Hospital
    Gothenburg, 41345, Sweden
  • Norrlands University Hospital, Department of Radiation Sciences, Oncology
    Umeå, Sweden
  • Charing Cross Hospital, Department of Medical Oncology
    London, United Kingdom
  • Royal Marsden NHS Foundation Trust - Institute of Cancer Research
    Sutton, United Kingdom
09

References and documents

Publications

  • Baum RP, Kulkarni HR, Schuchardt C, Singh A, Wirtz M, Wiessalla S, Schottelius M, Mueller D, Klette I, Wester HJ. 177Lu-Labeled Prostate-Specific Membrane Antigen Radioligand Therapy of Metastatic Castration-Resistant Prostate Cancer: Safety and Efficacy. J Nucl Med. 2016 Jul;57(7):1006-13. doi: 10.2967/jnumed.115.168443. Epub 2016 Jan 21. PubMed 26795286 ↗
  • Hansen AR, Probst S, Beauregard JM, Viglianti BL, Michalski JM, Tagawa ST, Sartor O, Tutrone RF, Oz OK, Courtney KD, Delpassand ES, Nordquist LT, Osman MM, Chi KN, Sparks R, George N, Hawley SM, Wu W, Jensen JD, Fleshner NE. Initial clinical experience with [177Lu]Lu-PNT2002 radioligand therapy in metastatic castration-resistant prostate cancer: dosimetry, safety, and efficacy from the lead-in cohort of the SPLASH trial. Front Oncol. 2025 Jan 7;14:1483953. doi: 10.3389/fonc.2024.1483953. eCollection 2024. PubMed 39839782 ↗
  • American College of Nuclear Medicine (ACNM) 2022 ACNM Annual Meeting AbstractsJanuary 27-29, 2022 Virtual Meeting. Clin Nucl Med. 2023 Feb 3:e246-e277. doi: 10.1097/RLU.0000000000004535. Online ahead of print. No abstract available. PubMed 36735603 ↗

Study documents

  • Study protocol · Jul 22, 2025
  • Statistical analysis plan · Jul 26, 2024

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04647526
Lead sponsor
POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Responsible party
Sponsor
First posted
Dec 1, 2020
Start date
Feb 25, 2021
Primary completion
Nov 1, 2023
Completion
Mar 2028 (estimated)
Results posted
Jan 13, 2026
Last update
Jan 13, 2026

Study contacts

Jessica Jensen
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

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