Recruiting

SPECT-CT

Sponsor:

BAMF Health

Code:

NCT05823402

Conditions

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SPECT/CT

Study Details

Brief 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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT05823402

Start date

May 1, 2023

Status verified date

May, 2023

Completion date

Oct 31, 2024

Anticipated

Primary completion date

Oct 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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)

Interventions

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.

Primary outcome measure

  • Dosimetry Method [ Time Frame: Immediately after the completion of SPECT/CT scanning. ]

Central Contacts and Locations

Locations

BAMF Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Dan Rogers

616-330-3886clinical.research@bamfhealth.com

More Information

Sponsor

BAMF Health

Last update posted

May 3, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BAMF Health on 2023-05-03.