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Prostate Cancer MetastaticPhase 1ACTIONNCT05567770

ACTInium-J591 Radionuclide Therapy in PSMA-Detected Metastatic HOrmone-Sensitive Recurrent Prostate CaNcer

A Phase 1 study testing Actinium-J591, Stereotactic Body Radiation Therapy and Androgen Deprivation Therapy in people with Prostate Cancer Metastatic, run by Weill Medical College of Cornell University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the safety of combining Actinium- J591 with radiation therapy or with androgen deprivation therapy. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
Actinium-J591, Stereotactic Body Radiation Therapy and Androgen Deprivation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2023to Jan 2030
Phase
Phase 1
Are there results?
None posted in the registry

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 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration.
  • Age ≥ 18 years
  • ECOG Performance Status 0-2.
  • Prior curative-intent treatment to the prostate, by either:
  • External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
  • Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
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  • Must meet study entry criteria based on the following diagnostic workup within 120 days prior to enrollment: • History and physical examination
  • 99mTc bone scan (Must be negative or equivocal);
  • Either CT or MRI of pelvis +/- abdomen (Must be negative or equivocal);
  • PSMA PET scan (Must be positive with exception of local disease); Note: All 3 scans are mandatory (bone scan; CT/MR; PET)
  • Serum total testosterone >100 ng/dL within 120 days prior to enrollment.
  • Be willing to use effective contraception during the entire study period.
  • To have adequate organ and marrow function, as defined below:
  • a. Absolute neutrophil count (ANC) of ≥2,000/mm3
  • b. Hemoglobin ≥9 g/dL without need for transfusion
  • c. Platelet count ≥150,000/mm3 and absent history or primary quantitative or qualitative platelet defect
  • d. Serum creatinine of ≤1.5 x ULN or calculated creatinine clearance of ≥60 mL/min/1.73 m2 by Cockcroft-Gault (or determined by 24 hour urine collection)
  • e. Serum total bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome, in which case direct bilirubin must be normal)
  • f. Serum AST and ALT ≤1.5 x ULN.

Who cannot join

  • 1. Currently on androgen deprivation or anti-androgen therapy.
  • Definitive radiologic evidence of metastatic disease on conventional imaging, defined by one of the following:
  • a. osseous metastasis on 99mTc radionuclide bone scan, or
  • b. extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
  • Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis. Note: Spinal metastases (PSMA PET- detected) with epidural extension are eligible if there is >0.3cm spatial separation between the gross tumor volume and spinal cord.
  • Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell).
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  • Prior metastatic or non-metastatic, invasive malignancy (except non metastatic, non-melanomatous skin cancer) unless continuously disease free for > 3 years.
  • Prior chemotherapy for prostate cancer or bilateral orchiectomy. Note: Prior chemotherapy for a different cancer is allowed if continuously disease-free for > 3 years.
  • Intrapelvic lymph nodes as only site of prostate cancer recurrence.
  • Received a platelet transfusion within 4 weeks of treatment
  • Received growth factors for white blood cells or platelets within 4 weeks of treatment
  • Prior treatment with unsealed radiation sources such as 89Strontium or 153Samarium-containing compounds (e.g. Metastron, Quadramet)
  • History of prior PSMA-TRT
  • Known history of myelodysplastic syndrome
  • Other serious illness(es) involving the cardiac, respiratory, central nervous, renal, hepatic, or hematological systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.

About this study

The purpose of this study is to evaluate the safety of combining Actinium- J591 with radiation therapy or with androgen deprivation therapy.

Read the detailed description

This is a two cohort pilot study for patients with hormone-sensitive prostate cancer after primary treatment +/- salvage treatment with metastases detected on PSMA-PET scan but equivocal, indeterminate or absent on conventional imaging.

Cohort 1 will have patients with Oligometastatic (low volume, between 1 and 5 metastases) disease and Cohort 2 will have patients with polymetastatic (high volume, ≥5 metastases) disease detected via PSMA PET.

Being tested
Actinium-J591, Stereotactic Body Radiation Therapy, Androgen Deprivation Therapy

What participants receive

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

  • Actinium-J591Drug

    Cohort 1 with oligometastatic disease will receive Actinium-J591 and Stereotactic Body Radiation Therapy

  • Stereotactic Body Radiation TherapyRadiation

    Also called SBRT

    Cohort 1 patients with oligometastatic disease will receive Actinium-J591 and Stereotactic Body Radiation Therapy

  • Androgen Deprivation TherapyDrug

    Also called ADT

    Cohort 2 patient with Polymetastatic disease will receive Actinium-J591 and Androgen Deprivation therapy (ADT)

Study groups in NCT05567770
Study groupRoleWhat they receive
Cohort 1Active comparatorNot described
Receives: Drug: Actinium-J591; Radiation: Stereotactic Body Radiation Therapy
Cohort 2Active comparatorNot described
Receives: Drug: Actinium-J591; Drug: Androgen Deprivation Therapy

What is being measured

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

  1. Dose Limiting Toxicity (DLT) Rate

    A DLT will is defined as a grade 3 or higher hematologic adverse event or a grade 2 or higher non-hematologic adverse event deemed to be at least possibly related to study treatment. Adverse events will be assessed using CTCAE version 5. Patients will be observed for a DLT for 3 months from the second dose of actinium-J591.

    Measured: 24 months

  2. Change in Maximum Tolerated Dose (MTD)

    Measured: 3,6,12,18 and 24 months.

Secondary outcomes (10)

  1. Progression Free Survival (PFS) on conventional Imaging

    Measured: 3 months

  2. Progression Free Survival (PFS) on conventional Imaging

    Measured: 6 months

  3. Progression Free Survival (PFS) on conventional Imaging

    Measured: 12 months

  4. Progression Free Survival (PFS) on conventional Imaging

    Measured: 24 months

  5. Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.

    Measured: 3 months

  6. Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.

    Measured: 6 months

  7. Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.

    Measured: 12 months

  8. Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.

    Measured: 24 months

  9. Changes in PSMA expression measured by comparison of SUV on PSMA PET scans before and after treatment

    Measured: 3, 6, 12, and 24 months

  10. Change in Percentage of PSA decline

    Measured: 3, 6, 12, 15, 18, 21, and 24 months.

Timeline

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

  1. First posted5 Oct 2022
  2. Study startDec 2023 (estimated)
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2030 (estimated)

Why it stopped: Stakeholder elected not to proceed with the study

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05567770
Sponsor's protocol ID
22-08025155
Acronym
ACTION
Status last verified
Aug 2023
First submitted
3 Oct 2022
Last updated
24 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Actinium-J591, Stereotactic Body Radiation Therapy and Androgen Deprivation Therapy in people with Prostate Cancer Metastatic, run by Weill Medical College of Cornell University.

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 19 inclusion and 15 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: withdrawn, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Dose Limiting Toxicity (DLT) Rate (time frame: 24 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?

On the ClinicalTrials.gov record for NCT05567770.

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 24 Aug 2023.

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