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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

— SPECTacular  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823402
• Other study ID #: BAMF-2022-02
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2023
• Source: BAMF Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	BAMF Health	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
BAMF Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.