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Biochemically Recurrent Prostate CarcinomaPhase 1NCT06105918

Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer

A Phase 1 study testing Biospecimen Collection, Computed Tomography and External Beam Radiation Therapy in people with Biochemically Recurrent Prostate Carcinoma and Prostate Adenocarcinoma, run by Emory University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase I trial tests the safety, side effects and best dose of radioligand therapy (lutetium Lu 177 PSMA-10.1 [177Lu-rhPSMA-10.1]) after prostate specific membrane antigen (PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating post-prostatectomy patients with prostate cancer that… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biospecimen Collection, Computed Tomography and External Beam Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
29 Nov 2023to 1 Apr 2029
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adenocarcinoma of the prostate, post radical prostatectomy with detectable prostate specific antigen (PSA)
  • Clinical PSMA PET/CT obtained, with findings of pelvic uptake only (prostate bed, pelvic lymph node uptake, or both)
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
  • Age over 18

Who cannot join

  • Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy or prior RLT)
  • Risk factors for Lu-rhPSMA radioligand therapy (Baseline >= grade 2 myelosuppression, renal insufficiency [glomerular filtration rate (GFR) < 60 mL/min], or xerostomia)
  • Definitive findings of systemic metastasis prior imaging (if obtained) or biopsy (if obtained)
  • Unacceptable medical or radiation safety risk
  • Unmanageable urinary tract obstruction or hydronephrosis; patients with diagnosed or who are at high risk of urinary retention
  • GFR < 60 mL/min or creatinine > 1.5-fold upper limit of normal (ULN)
Show all 16Show fewer
  • Liver enzymes > 5-fold ULN
  • Total white cell count less than 2.5 x 10^9 /L
  • Platelet count less than 75 x 10^9 /L
  • Any baseline grade 2 or above myelosuppression, nephrotoxicity, hepatotoxicity, xerostomia, or gastrointestinal (GI) toxicity
  • Severe acute co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Phase 1 Trial to Determine Safety and Feasibility in Treating Biochemical Recurrence Post-Prostatectomy With PSMA PET Guided External Beam Radiotherapy Followed by Consolidative Radioligand Therapy

This phase I trial tests the safety, side effects and best dose of radioligand therapy (lutetium Lu 177 PSMA-10.1 [177Lu-rhPSMA-10.1]) after prostate specific membrane antigen (PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating post-prostatectomy patients with prostate cancer that has come back after a period of improvement (recurrent). In this study, radioligand therapy is a radioactive drug called 177Lu-rhPSMA-10.1. It works by binding to PSMA-expressing prostate tumor cells and delivering the radioactive portion of the drug directly to the tumor cells while not harming normal cells. Radiation therapy such as external beam radiotherapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radioligand therapy with PSMA PET-guided external beam radiotherapy may kill more tumor cells in post-prostatectomy patients with biochemically recurrent prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Demonstrate the safety and feasibility of treating radiotherapy (RT) prostate cancer patients via addition of lutetium Lu 177 PSMA-10.1 (177Lu-rhPSMA-10.1) in a selected post-prostatectomy population.

II. Analyze dosimetry of radioligand therapy (RLT) after each cycle of 177Lu-rhPSMA-10.1.

EXPLORATORY OBJECTIVE:

  1. Determine the feasibility of and develop preliminary data in the correlation of circulating tumor circulating tumor deoxyribonucleic acid (ctDNA) at baseline, after RT, and RLT.

OUTLINE: This is a dose-escalation study of 177Lu-rhPSMA-10.1.

Patients undergo external beam radiation therapy (EBRT) followed by 177Lu-rhPSMA-10.1 intravenously (IV) on study. Patients also receive flotufolastat F-18 (rhPSMA-7.3) IV with positron emission tomography (PET)/computed tomography (CT) at screening and undergo single-photon emission computed tomography (SPECT)-CT and collection of blood samples on study.

Patients follow up 6 weeks after the last 177Lu-rhPSMA-10.1 administration.

Being tested
Biospecimen Collection, Computed Tomography, External Beam Radiation Therapy, Flotufolastat F-18, Lutetium Lu 177 PSMA-10.1

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, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

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

    Undergo rhPSMA-7.3 PET/CT and SPECT-CT

  • External Beam Radiation TherapyRadiation

    Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy

    Undergo EBRT

  • Flotufolastat F-18Other

    Also called (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3

    Given IV

  • Lutetium Lu 177 PSMA-10.1Drug

    Also called (177Lu) rhPSMA-10.1, 177Lu Radiohybrid PSMA-10.1, 177Lu rhPSMA-10.1, 177Lu-rhPSMA-10.1

    Given IV

  • Positron Emission TomographyProcedure or surgery

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

    Undergo rhPSMA-7.3 PET/CT

  • Single Photon Emission Computed TomographyProcedure or surgery

    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 scan

Study groups in NCT06105918
Study groupRoleWhat they receive
Treatment (EBRT, 177Lu-rhPSMA-10.1)ExperimentalPatients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: External Beam Radiation Therapy; Other: Flotufolastat F-18; Drug: Lutetium Lu 177 PSMA-10.1; Procedure: Positron Emission Tomography; Procedure: Single Photon Emission Computed Tomography

What is being measured

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

  1. Incidence of radiotherapy and radioligand therapy related adverse events

    Will be summarized descriptively using frequencies and percentages of all captured toxicities by grade and relevance.

    Measured: Up to 6 weeks post last radioligand therapy dose

Secondary outcomes (4)

  1. Tumor and organ at risk dosimetry

    Descriptive statistics will be used to perform the post-hoc dosimetry for tumor as applicable and background organs after each cycle of radioligand therapy.

    Measured: At 1-3 days and 4-7 days post radioligand therapy

  2. Circulating tumor deoxyribonucleic acid (ctDNA) differences

    Descriptive statistics (number of subject, mean, median, standard deviation, minimum, and maximum) will be used to summarize baseline ctDNA and post-radiotherapy ctDNA. Wilcoxon Signed-Ranks Test or paired samples t-test will be used to perform comparisons.

    Measured: Up to 5 years

  3. ctDNA differences

    Descriptive statistics (number of subject, mean, median, standard deviation, minimum, and maximum) will be used to summarize post radiotherapy ctDNA and post-radioligand therapy ctDNA. Wilcoxon Signed-Ranks Test or paired samples t-test will be used to perform comparisons.

    Measured: Up to 5 years

  4. ctDNA differences

    Descriptive statistics (number of subject, mean, median, standard deviation, minimum, and maximum) will be used to summarize baseline ctDNA and post-radioligand therapy ctDNA. Wilcoxon Signed-Ranks Test or paired samples t-test will be used to perform comparisons.

    Measured: Up to 5 years

Timeline

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

  1. First posted30 Oct 2023
  2. Study start29 Nov 2023
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 Apr 2029 (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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06105918
Sponsor's protocol ID
STUDY00005677
Other IDs
NCI-2023-03480, STUDY00005677, RAD5633-23, P30CA138292
Status last verified
Dec 2025
First submitted
10 Oct 2023
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wurzer A, De Rose F, Fischer S, Schwaiger M, Weber W, Nekolla S, Wester HJ, Eiber M, D'Alessandria C. Preclinical comparison of [177Lu]Lu-rhPSMA-10.1 and [177Lu]Lu-rhPSMA-10.2 for endoradiotherapy of prostate cancer: biodistribution and dosimetry studies. EJNMMI Radiopharm Chem. 2024 Feb 26;9(1):18. doi: 10.1186/s41181-024-00246-2.

    PubMed 38407630

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, Computed Tomography and External Beam Radiation Therapy in people with Biochemically Recurrent Prostate Carcinoma and Prostate Adenocarcinoma, run by Emory University 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 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of radiotherapy and radioligand therapy related adverse events (time frame: Up to 6 weeks post last radioligand therapy dose). 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 NCT06105918, which also lists 1 linked publication.

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 9 Dec 2025.

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