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Active, Not Recruiting

NCT Number: NCT03204123

PSMA PET Imaging of Recurrent Prostate Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Adenocarcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Ga-HBED-iPSMA PET

Drug

Patients will be injected with 100-300 MBq of 68Ga-HBED-iPSMA and after a waiting of 60-90 minutes patients will be scanned from mid-skull to mid-thigh.

PET/CT

Diagnostic Test

PET/CT will be acquired using a GE 710 or 690 time-of-flight PET/CT scanner. Following a waiting period of 60-90 minutes post 68Ga-HBED-iPSMA administration, patients will be scanned from top of the skull to mid-thigh. Images will be acquired with patients in a supine position with their arms raised above their head. If patients cannot raise their arms above the head, the arms will be comfortably positioned and secured by the side of the patient. The PET may be combined with a CT scan as a PET/CT or a MRI scan as PET/MR.

MRI

Diagnostic Test

Patients may undergo a diagnostic MRI of the prostate, other body parts or a whole-body MRI at the same imaging session as clinically indicated.

Primary outcomes

  1. Disease localization by PSMA PET/MR

    Time frame: 2 years

Secondary outcomes

  1. PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT

    Time frame: 2 years

  2. Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2017
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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