PSMA PET Imaging of Recurrent Prostate Cancer

Phase 2

Active, not recruiting

• Conditions: Prostate Adenocarcinoma; Prostate Cancer
• Interventions: Drug: Ga-HBED-iPSMA PET; Diagnostic Test: PET/CT; Diagnostic Test: MRI

• Registration Number: NCT03204123
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-26
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-06-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 1171

Inclusion Criteria

• Biopsy proven adenocarcinoma of the prostate

• Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible)

• For patients initially treated with surgery, radiation therapy, brachytherapy, or cryotherapy:

  • PSA ≥ 0.2 ng/mL in at least two consecutive tests within 6 months of date of consent for patients
  • Note: The most recent PSA value must be within 6 weeks of consent

• For patients who have received additional treatment in the recurrent or metastatic setting:

  ° PSA ≥ 2 ng/ml above the most recent therapy nadir

• Age ≥ 18 years

• Patient must be able to tolerate PET/CT or PET/MR imaging

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Exclusion Criteria

• Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ga-HBED-iPSMA PET with CT or MRI	Ga-HBED-iPSMA PET	Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
Ga-HBED-iPSMA PET with CT or MRI	PET/CT	Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
Ga-HBED-iPSMA PET with CT or MRI	MRI	Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
Ga-HBED-iPSMA PET with MRI	Ga-HBED-iPSMA PET	Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.
Ga-HBED-iPSMA PET with MRI	MRI	Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.

Primary Outcome Measures

Name	Time	Method
Disease localization by PSMA PET/MR	2 years

Secondary Outcome Measures

Name	Time	Method
PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT	2 years
Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)	2 years	The safety and tolerability of 68Ga-HBED-iPSMA will be followed by assessing the incidence, nature and severity of toxicities by common terminology criteria for adverse events (CTCAE v4.0)

Trial Locations

Locations (7)

Memorial Sloan Kettering Nassau (Consent only); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Monmouth (Consent only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent only ); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Consent only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (Consent only); 🇺🇸 Harrison, New York, United States