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

NCT05567770 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 22-08025155
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• 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.

  24 months

• Change in Maximum Tolerated Dose (MTD)

  3,6,12,18 and 24 months.

Secondary Outcomes (10)

• Progression Free Survival (PFS) on conventional Imaging

  3 months

• Progression Free Survival (PFS) on conventional Imaging

  6 months

• Progression Free Survival (PFS) on conventional Imaging

  12 months

• Progression Free Survival (PFS) on conventional Imaging

  24 months

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

  3 months

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

Drug: Actinium-J591; Radiation: Stereotactic Body Radiation Therapy

Cohort 2

ACTIVE COMPARATOR

Drug: Actinium-J591; Drug: Androgen Deprivation Therapy

Interventions

Actinium-J591 DRUG

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

Cohort 1; Cohort 2

Stereotactic Body Radiation Therapy RADIATION

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

Also known as: SBRT

Cohort 1

Androgen Deprivation Therapy DRUG

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

Also known as: ADT

Cohort 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Must meet study entry criteria based on the following diagnostic workup within 120 days prior to enrollment: • History and physical examination
• mTc 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

You may not qualify if:

• \. 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).
• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Convergent Therapeutics, Inc.: collaborator

MeSH Terms

Interventions

Radiosurgery; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Himanshu Nagar, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 5, 2022
• Study Start: December 1, 2023
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share