Malignant Neoplasm of ProstatePhase 1/2STARLiTNCT06574880
STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer
A Phase 1/2 study testing Lu-PSMA-617 and 5-fraction Stereotactic Body Radiation Therapy (SBRT) in people with Malignant Neoplasm of Prostate and Locally Advanced Prostate Cancer, run by Angela Y. Jia, MD PhD at 1 site in United States.
Trial summary
The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Malignant Neoplasm of Prostate, Locally Advanced Prostate Cancer
- What is being tested?
- Lu-PSMA-617 and 5-fraction Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to 1 Mar 2027
- Phase
- Phase 1/2
- 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
Who may be able to join
- Participant must be ≥ 18 years of age.
- ECOG performance status ≤ 1
- Histologic confirmation of prostate adenocarcinoma of the prostate
- PSMA avid disease on PSMA PET/CT, where the tumor in the prostate has SUVmax ≥ 10.
- PSMA PET/CT must be obtained within 4 months.
- Need ≥ 1 criteria:
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- Node positive disease on PSMA PET/CT or conventional imaging, as defined by having any of the following:
- Pelvic nodal disease (cN1) as defined by LN stations that commence at the bifurcation of the common iliac vessels
- Regional nodal disease (M1a) as defined by LN stations that commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.
- In the absence of nodal metastasis, must have ≥ 2 of the following
- i. cT3a or cT3b by conventional imaging (MRI) or PSMA PET/CT
- ii. Grade group ≥ 4
- iii. PSA ≥ 40 ng/mL
- Adequate organ and marrow function to receive treatment:
- Hemoglobin > 10 g/dL
- White blood cell (WBC) > 3000 / mL
- Absolute neutrophil count ≥ 1,500 / mcL
- Platelets ≥ 100,000 / mcL
- Creatinine ≤ 1.5x ULN
- Estimated glomerular filtration rate (eGFR)* > 50 mL/min
- Total bilirubin** < 2× ULN
- Albumin > 3 g/dL
- Aspartate aminotransferase (AST) < 3× ULN
- *based upon Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Participants with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only participants with non-obstructive pathology will be included in the study.
- ** Total bilirubin ≤ 2x ULN (except for participants with known Gilbert's Syndrome ≤ 3x ULN is permitted)
- International Prostate Symptoms Score (IPSS) ≤ 15.
- Medically fit for treatment and agreeable to follow-up.
- Ability to understand and the willingness to sign a written informed consent.
- Participants with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 14 weeks from receiving the last dose of Lu-PSMA-617. Participants must also not donate sperm for 14 weeks from receiving the last dose of Lu-PSMA-617.
Who cannot join
- Clinical or radiographic evidence of distant metastatic disease (M1a above aortic bifurcation, M1b, or M1c) by any imaging. Participants are allowed to M1a nodal disease that is below the aortic bifurcation. Negative PSMA PET/CT is an acceptable substitute to conventional staging.
- Prostate gland size >90 cc measured by CT, ultrasound, or MRI
- Prior head and neck radiation therapy.
- Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy).
- Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.
- Prohibited 3 months before participant registration and during administration of study treatment: oral ketoconazole, , estrogens, and radiopharmaceuticals.
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- History of prior pelvic radiation therapy.
- Enrollment concurrently in another investigational drug study within 6 months of registration.
- History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer.
- History of prior myelodysplastic syndrome or acute leukemia.
- History of or active Crohn's disease or ulcerative colitis.
- Contraindication to or inability to tolerate PSMA/PET.
- Any condition that in the opinion of the investigator would preclude participation in this study.
- Inability to adhere to radiation safety measures in hospital or at home
- Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other
- Reduced salivary gland function with baseline CTCAE Gr > 1 dry mouth will be excluded.
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 Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: STARLiT: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer: A Phase I/II Trial
The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer.
Participants will receive one dose of Pluvicto, followed by radiation about 6 weeks later. Radiation therapy will be completed in 5 treatments over the period of 2 weeks. A second dose of Pluvicto will be given 6 weeks after radiation is complete. Some participants may also receive a third dose of Pluvicto, and this would be given 6 weeks after the second dose of Pluvicto.
Read the detailed description
Prostate cancer is the most common cancer in men worldwide and second leading cause of cancer death in men. The most common treatment for prostate cancer is radiation therapy (RT) plus long-term androgen deprivation therapy (ADT) for 18-36 months with a consideration for the addition of abiraterone acetate.
With the introduction of abiraterone and other second generation androgen signaling inhibitors (ARSIs) there is great interest in shortening the duration of systemic therapy. This interest stems from the high toxicity rates of ADT and substantial impact on patient-reported quality of life (QoL). The use of ADT is associated with some adverse events. Therefore, the combination of adverse event risks and decrease in quality of life associated with castration have resulted in decreased compliance to long term ADT and even ARSIs, where approximately 50% of patients with locally advanced disease either decline any ADT or stop treatment early. The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer.
This clinical trial will evaluate the safety of using Lu-PSMA-617 with SBRT to the prostate and pelvic lymph nodes, and to determine whether Lu-PSMA-617 can replace androgen deprivation therapy (ADT) to improve oncologic outcomes by use of cytotoxic agents, avoid ADT related side effects, and improve compliance for participants to receive systemic therapy.
- Being tested
- Lu-PSMA-617, 5-fraction Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu-PSMA-617Drug
Also called Pluvicto
Lu-PSMA will be administered at a fixed dose of 7.4GBq per cycle, on a dose escalation schedule:
- Level 0: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT.
- Level 1 (Starting Dose Level): Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2.
- Level 2: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2, followed 6 weeks later by cycle 3.
5-fraction Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called SBRT
Prostate and nodal SBRT will begin at the completion of cycle 1 (6 weeks after the first Lu-PSMA-617 infusion, ± 4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Lu-PSMA-617 + SBRT | Experimental | * Lu-PSMA-617: 7.4GBq intravenous infusion once with cycle 1, followed by 7.4GBq cycle 2 that is delivered 6 weeks after SBRT , and potentially 7.4GBq cycle #3 delivered 6 weeks after cycle #2 pending dose escalation
* Radiation therapy: 5 fractions to prostate and elective nodal irradiation, SBRT, delivered 6 weeks after cycle 1 of 177Lu-PSMA-617 Receives: Drug: Lu-PSMA-617; Radiation: 5-fraction Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum tolerated dose (MTD) of Lu-PSMA-617
The Phase I goal is to determine the maximally tolerated dose (MTD) of Lu-PSMA-617 when administered with prostate SBRT treatment. The MTD will be captured by analyzing the incidence of dose limiting toxicities occurring within the four weeks after the last dose of treatment.
Measured: 4 weeks after final dose of treatment (treatment expected to last up to six months)
Phase II: Androgen deprivation therapy (ADT)-free survival
The Phase II goal is to determine the 3-year rate of ADT-free survival.
Measured: 3 years post treatment
Secondary outcomes (14)
PSA Progression Free Survival
PSA progression-free survival will be analyzed at 24 months post last dose of treatment.
Measured: 2 years post treatment
Overall Survival (OS)
Overall Survival (OS) is defined as the time from Day 1 until death due to any cause. For subjects who do not die, time to death will be censored at the time of last contact.
Measured: 5 years post treatment
Prostate Cancer-specific Survival (PCSM)
Prostate cancer specific mortality (PCSM) is defined the time from Day 1 to death directly attributable to prostate cancer, death from treatment complications, or death from unknown causes in participants with active prostate cancer or previously documented clinical or biochemical relapse.
Measured: 5 years post treatment
Cumulative incidence of distant metastases
Distant metastases (DM) is defined as the time from Day 1 until development of distant metastases on CT, MRI, bone scan or PSMA PET, or death from prostate cancer.
Measured: 5 years post treatment
Time to any salvage therapy
The time to any salvage therapy, or Time-to-next-intervention (TTNI), is defined as is defined as the time from Day 1 to the time of initiation of any additional (i.e., outside of planned protocol treatment) cancer-directed therapy, including but not limited to androgen deprivation, other systemic prostate cancer therapeutics, palliative radiotherapy, or surgical intervention specifically addressing complications of metastases. In the absence of a defining event, TTNI will be censored at the date of last visit documenting absence of interventions.
Measured: 5 years post treatment
Change in Quality of life score as measured by EPIC-26
EPIC-26 is a short form version of the full Expanded Prostate Cancer Index Composite (EPIC). This version contains 26 items and the same 5 domains as the full version of EPIC: urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Response options for each EPIC item for a Likert scale, and multi-item scare scores are transported linearly to a 0-100 scale with higher scores representing better QoL. The time frame asked in the question relates to symptoms experienced within the prior 4 weeks.
Measured: Baseline to 5 years post treatment
Change in Quality of life score as measured by XeQoLS
Xerostomia-related Quality of Life Questionnaire (XeQoLS) is a questionnaire used to measure how dry mouth and salivary dysfunction affect participants' quality of life (QoL). This questionnaire consists of 15 questions across four major domains: physical functioning, personal/psychological functioning, social functioning, and pain/discomfort issues. The XeQoLS is a self-administered tool, and participants are asked to rate each symptom on a 5-point Likert scale from 0 to 4, with higher scores indicating increased xerostomia burden. An average of scores in each domain is calculated, and the average score ranges from 0 to 4. A total score is calculated as an average of the scores from each of the domain.
Measured: Baseline to 5 years post treatment
Change in Quality of life score as measured by FACT-RNT
FACT-RNT is a patient-reported outcomes (PRO) measure for PCa participants receiving radionuclide therapy. It has not yet been validated in a prospective manner. It consists of 15 questions on a 5-point Likert scale, in a recall period of the past 7 days. Each item score is added, and the sum is linearly transformed to produce the final summary score ranging from 0 to 100, with higher scores representing better QoL.
Measured: Baseline to 5 years post treatment
Time-to-castration-resistant prostate cancer
To determine the average time-to-castration-resistant prostate cancer.
Measured: 5 years post treatment
Rate of participants with post treatment PSA in goal range
Rate of obtaining a post-treatment PSA of ≤ 0.5 ng/mL following treatment with 177Lu-PSMA-617 and prostate and nodal SBRT.
Measured: 12 weeks post treatment
Incidence of acute toxicity
The goal is to describe acute toxicity following treatment with Lu-PSMA-617 and prostate and nodal SBRT.
Measured: 5 years post treatment
Incidence of late toxicity
The goal is to describe late treatment toxicity following treatment with Lu-PSMA-617 and prostate and nodal SBRT.
Measured: 5 years post treatment
Biochemical recurrence (BCR)
To determine the rate of biochemical recurrence (BCR), defined as PSA nadir + 2 ng/mL.
Measured: 5 years post treatment
Proportion of participants with PSA50-RR
The proportion of participants with PSA50-RR at 12 weeks post all treatment will be summarized with 95% confidence interval (CI), where PSA50-RR is defined as the proportion of men with a PSA reduction of at least 50% at 6 weeks after the last 177Lu-PSMA-617 treatment, compared with baseline PSA prior to 177Lu-PSMA-617 treatment.
Measured: 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start13 May 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of ProstateStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angela Y. Jia, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Angela Y. Jia, MD PhD, Case Comprehensive Cancer Center
- Investigators
- Angela Y Jia, MD, PhD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterDaniel E Spratt, MD, Study chair, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574880
- Sponsor's protocol ID
- CASE7824
- Acronym
- STARLiT
- Status last verified
- Apr 2026
- First submitted
- 26 Aug 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlies publication
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STARLiT: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer: A Phase I/II Trial
- ClinicalTrials.gov ID
- NCT06574880
- Acronym / sponsor ID
- STARLiT / CASE7824
- Keywords
- Prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Angela Y. Jia, MD PhDUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Aug 2024 (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.
The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer.
Participants will receive one dose of Pluvicto, followed by radiation about 6 weeks later. Radiation therapy will be completed in 5 treatments over the period of 2 weeks. A second dose of Pluvicto will be given 6 weeks after radiation is complete. Some participants may also receive a third dose of Pluvicto, and this would be given 6 weeks after the second dose of Pluvicto.
Detailed description
Prostate cancer is the most common cancer in men worldwide and second leading cause of cancer death in men. The most common treatment for prostate cancer is radiation therapy (RT) plus long-term androgen deprivation therapy (ADT) for 18-36 months with a consideration for the addition of abiraterone acetate.
With the introduction of abiraterone and other second generation androgen signaling inhibitors (ARSIs) there is great interest in shortening the duration of systemic therapy. This interest stems from the high toxicity rates of ADT and substantial impact on patient-reported quality of life (QoL). The use of ADT is associated with some adverse events. Therefore, the combination of adverse event risks and decrease in quality of life associated with castration have resulted in decreased compliance to long term ADT and even ARSIs, where approximately 50% of patients with locally advanced disease either decline any ADT or stop treatment early. The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer.
This clinical trial will evaluate the safety of using Lu-PSMA-617 with SBRT to the prostate and pelvic lymph nodes, and to determine whether Lu-PSMA-617 can replace androgen deprivation therapy (ADT) to improve oncologic outcomes by use of cytotoxic agents, avoid ADT related side effects, and improve compliance for participants to receive systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu-PSMA-617 + SBRT | Experimental | Drug: Lu-PSMA-617, Radiation: 5-fraction Stereotactic Body Radiation Therapy (SBRT)* Lu-PSMA-617: 7.4GBq intravenous infusion once with cycle 1, followed by 7.4GBq cycle 2 that is delivered 6 weeks after SBRT , and potentially 7.4GBq cycle #3 delivered 6 weeks after cycle #2 pending dose escalation * Radiation therapy: 5 fractions to prostate and elective nodal irradiation, SBRT, delivered 6 weeks after cycle 1 of 177Lu-PSMA-617 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Participant must be ≥ 18 years of age.
- ECOG performance status ≤ 1
- Histologic confirmation of prostate adenocarcinoma of the prostate
- PSMA avid disease on PSMA PET/CT, where the tumor in the prostate has SUVmax ≥ 10.
- Need ≥ 1 criteria:
Key exclusion criteria (16 listed)
- Clinical or radiographic evidence of distant metastatic disease (M1a above aortic bifurcation, M1b, or M1c) by any imaging. Participants are allowed to M1a nodal disease that is below the aortic bifurcation. Negative PSMA PET/CT is an acceptable substitute to conventional staging.
- Prostate gland size >90 cc measured by CT, ultrasound, or MRI
- Prior head and neck radiation therapy.
- Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy).
- Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.
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 |
|---|---|---|
| Lu-PSMA-617Also: PluvictoLu-PSMA will be administered at a fixed dose of 7.4GBq per cycle, on a dose escalation schedule: * Level 0: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT. * Level 1 (Starting Dose Level): Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2. * Level 2: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2, followed 6 weeks later by cycle 3. | Drug | Lu-PSMA-617 + SBRT |
| 5-fraction Stereotactic Body Radiation Therapy (SBRT)Also: SBRTProstate and nodal SBRT will begin at the completion of cycle 1 (6 weeks after the first Lu-PSMA-617 infusion, ± 4 weeks). | Radiation | Lu-PSMA-617 + SBRT |
Primary outcome
Phase I: Maximum tolerated dose (MTD) of Lu-PSMA-617
Time frame: 4 weeks after final dose of treatment (treatment expected to last up to six months)
The Phase I goal is to determine the maximally tolerated dose (MTD) of Lu-PSMA-617 when administered with prostate SBRT treatment. The MTD will be captured by analyzing the incidence of dose limiting toxicities occurring within the four weeks after the last dose of treatment.
Phase II: Androgen deprivation therapy (ADT)-free survival
Time frame: 3 years post treatment
The Phase II goal is to determine the 3-year rate of ADT-free survival.
14 secondary outcomes
PSA Progression Free Survival
Time frame: 2 years post treatment
Overall Survival (OS)
Time frame: 5 years post treatment
Prostate Cancer-specific Survival (PCSM)
Time frame: 5 years post treatment
Cumulative incidence of distant metastases
Time frame: 5 years post treatment
Time to any salvage therapy
Time frame: 5 years post treatment
Change in Quality of life score as measured by EPIC-26
Time frame: Baseline to 5 years post treatment
Change in Quality of life score as measured by XeQoLS
Time frame: Baseline to 5 years post treatment
Change in Quality of life score as measured by FACT-RNT
Time frame: Baseline to 5 years post treatment
Time-to-castration-resistant prostate cancer
Time frame: 5 years post treatment
Rate of participants with post treatment PSA in goal range
Time frame: 12 weeks post treatment
Incidence of acute toxicity
Time frame: 5 years post treatment
Incidence of late toxicity
Time frame: 5 years post treatment
Biochemical recurrence (BCR)
Time frame: 5 years post treatment
Proportion of participants with PSA50-RR
Time frame: 12 weeks post treatment
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 26 May 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlies publication
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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.
Angela Y Jia, MD, PhD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Daniel E Spratt, MD study chair
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lu-PSMA-617 and 5-fraction Stereotactic Body Radiation Therapy (SBRT) in people with Malignant Neoplasm of Prostate and Locally Advanced Prostate Cancer, run by Angela Y. Jia, MD PhD 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 29 inclusion and 16 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 26 May 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Angela Y Jia, MD, PhD (216-844-3262, Angela.Jia@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Maximum tolerated dose (MTD) of Lu-PSMA-617 (time frame: 4 weeks after final dose of treatment (treatment expected to last up to six months)). 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?
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 26 May 2026.