Recruiting
Phase 2

68Ga-PSMA PET-CT

Sponsor:

Ebrahim Delpassand

Code:

NCT02282137

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

68Ga-PSMA

Study Details

Brief summary:

This is a phase II clinical trial study to show how well the 68Ga-PSMA-11 (ProstaMedix™) PET-CT scan works in detecting tumor location and size in patients with suspected or confirmed prostate cancer, as well as prostate cancer that may have come back in patients with elevated PSA ( a prostate-specific antigen tumor marker) after initial treatment.

Conditions

Prostate Cancer

Study ID

NCT02282137

Start date

May, 2015

Status verified date

Aug, 2020

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

General requirements:

1. Karnofsky performance status of ≥50 (or ECOG/WHO equivalent).
2. Age > 18 years .
3. Ability to understand a written informed consent document, and the willingness to sign it.
4. i. inclusion criteria specific for the pre-prostatectomy group:

  • Biopsy proven prostate adenocarcinoma.
  • Planned prostatectomy with lymph node dissection.
  • Intermediate to high-risk disease (as determined by elevated PSA \[PSA>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score > 6\] or other risk factors).

4. ii. inclusion criteria specific for biochemical recurrence group:

  • Histopathological proven prostate adenocarcinoma.
  • Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

1. Post radical prostatectomy (RP) - AUA recommendation, PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
2. Post-radiation therapy -ASTRO-Phoenix consensus definition, Nadir + greater than or equal to 2 ng/mL rise in PSA 5. Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET

Exclusion Criteria

General requirements:

1. Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
2. Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criterion can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
3. i. Exclusion criteria specific for the pre-prostatectomy group: Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu) within the last 2 months.

3. ii. Exclusion criteria specific for biochemical recurrence group:

  • Investigational therapy for prostate cancer for less than 2 months.
  • Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Study Design

Enrollment

208 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 68Ga-PSMA

Evaluation of concordance and discordance between the results of 68Ga-PSMA PET/CT and other available conventional imaging modalities (such as CT, MRI, FDG, NaF scan), histology or follow up.

Interventions

68Ga-PSMA

Patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.

Primary outcome measure

  • The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location. [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Radio- Isotope Therapy of America

Recruiting

Houston, Texas, United States, 77042

Contacts

Principal Investigator:

Rodolfo Nunez, MD

More Information

Sponsor

Ebrahim Delpassand

Last update posted

Aug 19, 2020

Last verified

Aug, 2020

Keywords

  • Prostate cancer
  • PET / CT
  • Ga-PSMA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ebrahim Delpassand on 2020-08-19.