Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study) (SPECTacular)

The SPECTacular study will enroll patients who are already undergoing a FDA approved PSMA-targeted Radioligand treatment cycle. During each treatment cycle, patients will receive 5 additional SPECT/CT scans to investigate the limits of agreement between dosimetry (absorbed radiation dose) approximation methods and dosimetry using the triexponential fitting method.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Diagnostic test: SPECT/CT

Detailed Description

All patients with PSMA-positive tumor and/or Metastases of Prostate Cancer (PSMA-TMPC) who would be undergoing a PSMA-targeted Radioligand Therapy (PRLT) based on independent eligibility criteria for the same, will receive 6 serial SPECT-CT scans for every treatment cycle as a part of our study. The purpose of this investigation is to assess the limits of agreement of commonly employed dosimetry methods used to determine or approximate absorbed doses for organs and tumors compared to a dosimetry method using a triexponential fit requiring 6 post-injection SPECT-CT scans for all treatment cycles.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • BAMF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male, 18 years old or older
4. Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
5. Patient is receiving PSMA-targeted Radioligand Therapy (PRLT) for treatment of PSMA-positive tumor and/or metastases of prostate cancer. Therapy may be FDA approved or investigational in nature under an approved clinical trial.
6. Ability to lay flat on scanner for duration of SPECT-CT imaging studies (1-2 hours)

Exclusion Criteria:

1. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
3. All criteria which may preclude a PSMA-radioligand therapy using Lu-177 PSMA-617 or Lu-177 PSMA I&T to be performed as per standardized guidelines and protocols laid down for these treatments and per decision by the treating physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SPECT/CT; All patients enrolled will undergo 5 additional (6 total) SPECT/CT scans per treatment cycle. Current FDA approved PSMA radioligand therapy is administered over 6 cycles, so there will be a total of 30 additional SPECT/CT scans during this study. During each treatment cycle, patients will have a SPECT/CT scan at the following time points after administration of PRLT: 4 Hours; 24 Hours (+/- 8 Hours); 48 Hours (+/- 8 Hours); 96 Hours (+/- 8 Hours); 168 Hours (+/- 24 Hours); 336 Hours (+/- 24 Hours)

Diagnostic test: SPECT/CT; SPECT/CT imaging can generate 3-dimensional images of the location where the PSMA radioligand therapy has accumulated in the body. SPECT/CT imaging can also measure doses of radiation delivered to those locations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetry Method	To determine the limits of agreements between dosimetry approximation methods and dosimetry using the triexponential fitting method.	Immediately after the completion of SPECT/CT scanning.

Collaborators and Investigators

• Sponsor: BAMF Health

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: BAMF-2022-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No