Metastatic Castration-Resistant Prostate CarcinomaNCT07096999
SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy
An observational study of Metastatic Castration-Resistant Prostate Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study is being performed to establish the association between absorbed dose to tumor and response and absorbed dose to normal organs and toxicity following Lu177-PSMA radioligand therapy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to 23 Jan 2031
- 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: Patients with mCRPC undergoing 177Lu-PSMA-617 treatment at the University of Michigan
Who may be able to join
- * 177Lu-617 PSMA treatment scheduled for mCRPC
- Clinically stable as determined by the nuclear medicine clinicians
- Male
- ≥ 18 years of age
- Willing and able to provide informed consent
Who cannot join
- Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
James Pool, 734-615-7391, jampool@med.umich.edu
Yuni K. Dewaraja
About this study
This study is being performed to establish the association between absorbed dose to tumor and response and absorbed dose to normal organs and toxicity following Lu177-PSMA radioligand therapy
- Being tested
- Non-Interventional Study
- Keywords
- Prostate Cancer, 177Lu, PSMA, mCRPC, Radioligand Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients receive standard care Pluvicto and undergo Lu-177 SPECT/CT scans on study. Patients may also undergo optional 99mTc-SC SPECT/CT scan for bone marrow dosimetry prior to cycle 1. In addition, patients have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response and toxicity following 177Lu-RLT
Association between absorbed dose and effect (response/toxicity) following 177Lu-RLT
Measured: Up to 4 years
Secondary outcomes (1)
Build and test models
Build and test models for predicting therapy delivered absorbed dose from pre-therapy PET imaging/non-imaging biomarkers.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start23 Jan 2025
- Primary completion23 Jan 2031 (estimated)
- Study completion23 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yuni K Dewaraja, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096999
- Sponsor's protocol ID
- UMCC 2024.070
- Other IDs
- NCI-2025-01555, HUM00257753, R01CA289631
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy
- ClinicalTrials.gov ID
- NCT07096999
- Acronym / sponsor ID
- UMCC 2024.070
- Keywords
- Prostate Cancer, 177Lu, PSMA, mCRPC, Radioligand Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 23 Jan 2031 (estimated)
- Study completion
- 23 Jan 2031 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being performed to establish the association between absorbed dose to tumor and response and absorbed dose to normal organs and toxicity following Lu177-PSMA radioligand therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients receive standard care Pluvicto and undergo Lu-177 SPECT/CT scans on study. Patients may also undergo optional 99mTc-SC SPECT/CT scan for bone marrow dosimetry prior to cycle 1. In addition, patients have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mCRPC undergoing 177Lu-PSMA-617 treatment at the University of Michigan
Key inclusion criteria (5 listed)
- * 177Lu-617 PSMA treatment scheduled for mCRPC
Key exclusion criteria (1 listed)
- Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Response and toxicity following 177Lu-RLT
Time frame: Up to 4 years
Association between absorbed dose and effect (response/toxicity) following 177Lu-RLT
1 secondary outcome
Build and test models
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Castration-Resistant Prostate Carcinoma
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Michigan Comprehensive Cancer Center
Ann Arbor, United States
Yuni K Dewaraja principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration-Resistant Prostate Carcinoma, run by University of Michigan Rogel Cancer Center 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 5 inclusion and 1 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 27 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response and toxicity following 177Lu-RLT (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.