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Metastatic Castration-Resistant Prostate CarcinomaPhase 1ESCENDONCT07682649

Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Gallium Ga 68 Gozetotide in people with Metastatic Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Gallium Ga 68 Gozetotide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Dec 2026to Dec 2031
Phase
Phase 1
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be eligible for standard Lu-177-PSMA617 RLT for mCRPC, including PSMA PET/CT scan positive (lesion uptake > liver uptake by visual assessment)
  • Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., prior chemotherapy, external beam radiation, brachytherapy, immunotherapy, etc.)
  • Patients must be ≥18 years of age
  • Patients must have an ECOG performance status of 0 or 1
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3
  • Platelet count ≥ 150,000/mm^3
Show all 13Show fewer
  • Hemoglobin ≥ 10.0 g/dL
  • Estimated glomerular filtration rate (EGFR) ≥ 60ml/min
  • Bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases
  • Albumin > 3.0 g/dL
  • Use effective birth control methods during the treatment and for 14 weeks after the last Lu-177-PSMA-617 dose
  • Ability to understand and the willingness to sign a written informed consent

Who cannot join

  • Does not meet criteria for standard Lu-177-PSMA-617 RLT
  • Diffuse marrow involvement evident on Ga-68-PSMA PET/CT as assessed by study treating clinician
  • Prior RLT
  • Unmanageable concurrent bladder outflow obstruction or urinary incontinence
  • Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation
  • Plan to start any additional anti-cancer therapy or investigational agents during study therapy. Anti-cancer therapies include chemotherapy and endocrine therapy
  • Exclusion criteria for participation in other investigational trials: should not participate during RLT or 30 days prior to start of RLT

Trial locations and contacts

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

Cancer AnswerLine contact

1-800-865-1125

CancerAnswerLine@med.umich.edu

United States1 site

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu

    Kirk A. Frey, MD

Other trials in United States

About this study

Official title: A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial

This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.

Being tested
Biospecimen Collection, Computed Tomography, Gallium Ga 68 Gozetotide, Lutetium Lu 177 Vipivotide Tetraxetan, Positron Emission Tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of urine samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo SPECT/CT

  • Gallium Ga 68 GozetotideOther

    Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC

    Given Ga-68 PSMA-11

  • Lutetium Lu 177 Vipivotide TetraxetanDrug

    Also called 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617

    Given IV

  • Positron Emission TomographyDevice

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

  • Questionnaire AdministrationOther

    Ancillary studies

  • Single Photon Emission Computed TomographyDevice

    Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography

    Undergo SPECT/CT

  • Technetium Tc-99m Sulfur ColloidOther

    Also called Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid

    Given IV

Study groups in NCT07682649
Study groupRoleWhat they receive
Dose Escalation (Lu-177-PSMA-617)ExperimentalPatients receive Lu-177-PSMA-617 IV on day 1 of each cycle. Dose escalation will occur in cycle 1 only: Level 1: 14.8 GBq (7.4 GBq administered 2 times, 2 days apart) Level 2: 22.2 GBq (7.4 GBq administered 3 times, each 2 days apart) Cycles repeat every 6 weeks for up to 5 cycles for dose level 1 and up to 4 cycles for dose level 2, with the Lu-177-PSMA-617 dose of 7.4 GBq, in the absence of disease progression or unacceptable toxicity. Patients also undergo SPECT/CT scans and receive Ga-68 PSMA-11 and undergo PET/CT after cycle 1.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Gallium Ga 68 Gozetotide; Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Device: Positron Emission Tomography; Other: Questionnaire Administration; Device: Single Photon Emission Computed Tomography; Other: Technetium Tc-99m Sulfur Colloid

What is being measured

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

  1. Dose limiting toxicity (DLT)

    The rate of drug-related adverse events that meet protocol-specified dose-limiting criteria and occur during the time period from administration of cycle 1 dosage up to administration of cycle 2 dosage.

    Measured: up to 6 weeks

Secondary outcomes (4)

  1. Incidence of treatment related adverse events

    Any treatment related adverse events of Grade 3 or higher (according to CTCAE v5.0) from time of cycle 1 administration until time of cycle 2 administration and from time of cycle 1 administration until 12 weeks after the last cycle administration

    Measured: at 6 weeks after first dose and 12 weeks after last dose

  2. Completion of overall multi-cycle (4-5 cycles) planned treatment course

    To determine the rate of successful completion of the complete planned treatment course (total of 4 or 5 cycles)

    Measured: Up to 30 weeks

  3. Biochemical (prostate-specific antigen [PSA]) response

    Will be estimated as the proportion of patients with ≥ 50% drop in serum PSA levels from baseline to 6 weeks after first cycle and from baseline to 12 weeks after last cycle

    Measured: at 6 weeks after first dose and 12 weeks after last dose

  4. PSMA PET/CT response

    Will be estimated as the proportion of patients with ≥ 30% drop in PSMA positive tumor volume on PET/CT from baseline to 6 weeks after first cycle and from baseline to 12 weeks after last cycle

    Measured: at 6 weeks after first dose and 12 weeks after last dose

Timeline

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

  1. First posted6 Jul 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07682649
Sponsor's protocol ID
UMCC 2023.044
Other IDs
NCI-2025-01952, HUM00234038, R01CA289631
Acronym
ESCENDO
Status last verified
Oct 2026
First submitted
26 Jun 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Gallium Ga 68 Gozetotide in people with Metastatic Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, 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 13 inclusion and 7 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: opening soon, as of the sponsor's last update on 15 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.

What does this 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.

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 Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: up to 6 weeks). 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 NCT07682649.

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 15 Oct 2026.

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