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Prostatic Neoplasms, Castration-ResistantPRISMNCT07697989

Pluvicto Real-world Investigation in Survival in Metastatic CRPC

An observational study of Prostatic Neoplasms, Castration-Resistant and Neoplasm Metastasis, run by Novartis Pharmaceuticals at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the various aspects of treatment effectiveness of [177Lu]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings. The study will be conducted using real-world data sources from the United States (US) and Germany. Read more about this study

Who is it for?
Ages 18 years and older, men only
How many people
1,085 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 31 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult male patients with mCRPC in the US and Germany, who received [177Lu]Lu-PSMA-617.

Who may be able to join

  • Patients with at least one inpatient OR two outpatient primary prostate cancer (PC) diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM]: C61) during the identification period. For outpatient diagnoses, the second confirmatory PC diagnosis must be at least 30 to 365 days after the first primary diagnosis date.
  • Patients with a metastatic diagnosis (ICD-10-CM: C77-C79) on or after the primary PC diagnosis date. The earliest metastatic diagnosis will be the patient's metastatic diagnosis date.
  • Patients with an mCRPC diagnosis on or after the metastatic diagnosis or satisfying any of the proxy criteria.
  • Patients with evidence of treatment with [177Lu]Lu-PSMA-617 after the mCRPC diagnosis date. The date of [177Lu]Lu-PSMA-617 administration will be considered as the index date.
  • Patients ≥18 years of age on metastatic diagnosis date.
  • Patients who are male.
  • Patients with at least 12 months pre-index and at least six months post-index (unless patient died) of medical history or continuous medical and pharmacy enrollment or activity (three-month allowable gap).

Who cannot join

  • Patients with other non-prostate primary cancer (≥ two ICD codes for one specific type of cancer in the baseline period at least 30 days apart) within three years prior to the first PC diagnosis.
  • Patients enrolled in a current clinical trial/investigational study within the 30-day period immediately prior to and including the index date or within five half-lives of the investigational product (whichever is longer) or during post-index period (ICD-10-CM: Z00.6).
  • Patients with missing age and gender information.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

+41613241111

novartis.email@novartis.com

Novartis Pharmaceuticals contact

United States1 site, 1 recruiting

  • Novartis

    East Hanover, New Jersey, 07936

    Recruiting

Other trials in United States

About this study

Official title: Real World Clinical Effectiveness of [177Lu]Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients: A Non-Interventional Study

This study aims to evaluate the various aspects of treatment effectiveness of [177Lu]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings. The study will be conducted using real-world data sources from the United States (US) and Germany.

Keywords
Pluvicto, 177Lu-PSMA-617, Metastatic Castration Resistant Prostate Cancer, Effectiveness, Survival
Medical subject headings
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07697989
Study groupRoleWhat they receive
Overall mCRPC CohortAdult male mCRPC patients who have received at least one dose of [177Lu]Lu-PSMA-617.
Chemo-naive mCRPC CohortA sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of [177Lu]Lu-PSMA-617 and have not received chemotherapy in the mCRPC stage.
Post-taxane mCRPC CohortA sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of [177Lu]Lu-PSMA-617 after taxane-based chemotherapy in the mCRPC stage.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Real-World Overall Survival (rwOS)

    rwOS, defined as the time from index date, i.e., date of [177Lu]Lu-PSMA-617 administration, until death due to any cause.

    Measured: Up to approximately 3 years

  2. Median rwOS

    Median rwOS, defined as the time from the index date, i.e., date of [177Lu]Lu-PSMA-617 administration, to when half of the patients in the cohort are still alive.

    Measured: Up to approximately 3 years

Secondary outcomes (26)

  1. Baseline Demographics

    Measured: Baseline

  2. Proportion of Patients by Clinical Characteristic

    Clinical characteristics (based on data availability):

    • Symptoms and signs of PC
    • Tumor characteristics
    • Prostate-specific membrane antigen (PSMA) positivity (PSMA positive, PSMA negative)
    • Previous therapies

    Measured: Baseline

  3. Proportion of Patients by Clinical Characteristic: Eastern Cooperative Oncology Group (ECOG) Performance Status

    ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).

    Measured: Baseline

  4. Proportion of Patients by Clinical Characteristic: Karnofsky Performance Status

    The Karnofsky performance status scale is an assessment scale used to measure an individual's functional status and ability to perform daily activities. The Karnofsky performance scale uses an 11-point scale in 10-point increments ranging from 100 (normal functioning) to 0 (deceased).

    Measured: Baseline

  5. Duration Between Metastatic PC Diagnosis and mCRPC Diagnosis

    Measured: Baseline

  6. Prostate Specific Antigen (PSA) Level

    Measured: Baseline

  7. Testosterone Level

    Measured: Baseline

  8. Lactate Dehydrogenase (LDH) Level

    Measured: Baseline

  9. Alkaline Phosphatase (ALP) Level

    Measured: Baseline

  10. Real-World Progression Free Survival (rwPFS)

    rwPFS, defined as the time from the index date to the date of first documented progression, or next treatment initiation, or death from any cause, whichever occurs first.

    Measured: Up to approximately 3 years

  11. Median rwPFS

    Median rwPFS, defined as the time from the index date to when half of the patients in the cohort have disease progression or death.

    Measured: Up to approximately 3 years

  12. Duration Between mCRPC Diagnosis and [177Lu]Lu-PSMA-617 Treatment Initiation

    Measured: Baseline

  13. Number of Patients by Number of [177Lu]Lu-PSMA-617 Cycles Received

    Measured: Up to approximately 3 years

  14. Time Interval Between Two Consecutive [177Lu]Lu-PSMA-617 Cycles

    Measured: Up to approximately 3 years

  15. Proportion of Patients With a Dose Modification

    Dose modification is defined as any change (reduction/escalation) in dose or frequency relative to the recommended dose in label.

    Measured: Up to approximately 3 years

  16. Time-to-First Dose Modification

    Dose modification is defined as any change (reduction/escalation) in dose or frequency relative to the recommended dose in label.

    Measured: Up to approximately 3 years

  17. Proportion of Patients who Discontinue Treatment

    Measured: Up to approximately 3 years

  18. Proportion of Patients who Switch Treatment

    Proportion of patients who discontinue [177Lu]Lu-PSMA-617 treatment and initiate new drug(s).

    Measured: Up to approximately 3 years

  19. Time-to-Treatment Discontinuation (TTD1L)

    Measured: Up to approximately 3 years

  20. Time-to-Next Treatment (TTNT)

    Time from initiation of [177Lu]Lu-PSMA-617 until the start date of the next treatment or death, whichever occurs first.

    Measured: Up to approximately 3 years

  21. Proportion of Patients With Adverse Events

    Measured: Up to 42 days after the last dose of [177Lu]Lu-PSMA-617

  22. Proportion of Patients With Safety Topics of Interest (STIs)

    STIs: renal events, myelosuppression (cytopenias, bone marrow failure), dry mouth, second primary malignancies (other malignancies than the primary prostate cancer, including hematological and solid malignancies), dry eye.

    Measured: Up to approximately 3 years

  23. Proportion of Prescriptions by Type of Specialty

    Measured: Baseline, up to approximately 3 years

  24. Proportion of Prescriptions by Type of Practice Setting

    Measured: Baseline, up to approximately 3 years

  25. Proportion of Patients by Type of Other Metastatic Prostate Cancer (mPC) Treatments Prior to [177Lu]Lu-PSMA-617 Treatment

    Measured: Baseline

  26. Proportion of Patients by Type of Other mPC Treatments After [177Lu]Lu-PSMA-617 Treatment

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start1 Oct 2026
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
1,085 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07697989
Sponsor's protocol ID
CAAA617A12008
Acronym
PRISM
Status last verified
Jul 2026
First submitted
22 Jun 2026
Last updated
30 Oct 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Neoplasms, Castration-Resistant and Neoplasm Metastasis, run by Novartis Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real-World Overall Survival (rwOS) (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07697989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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