68Ga-PSMA PET-CT Scan for Diagnosis and Management of Prostate Cancer (PSMA)
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|ClinicalTrials.gov Identifier: NCT02282137|
Recruitment Status : Recruiting
First Posted : November 4, 2014
Last Update Posted : August 19, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 68Ga-PSMA||Phase 2|
68Ga-PSMA-11 is a radioactive imaging contrast agent for use in PET CT scan that seeks to identify prostate cancer cells that have a specific protein target called prostate-specific membrane antigen (PSMA) on their surface. PET and CT make computerizing pictures of areas inside the body where the radioactive substance is lighting up. 68Ga-PSMA-11 PET / CT may be able to see smaller tumors than standard imaging and may help determine whether prostate cancer has come back and where it is in the body.
A 68Ga-PSMA-11 PET / CT scan may help doctors to better detect the location, extent, and characteristics of the tumor, allowing improved planning of subsequent therapy
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||68Ga-PSMA (ProstaMedix™) PET-CT Scan for Diagnosis and Management of Prostate Cancer|
|Actual Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
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.
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.
Other Name: 68Ga-HBED-CC-PSMA
- The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location. [ Time Frame: 12 months ]The sensitivity of 68Ga-PSMA-11 PET to detect tumor location and metastases in patients with biopsy confirmed diagnosis.tumor location confirmed by histopathology/biopsy and conventional imaging follow-up.
- Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value [ Time Frame: 12 months ]Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value (0.2 - <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, 5.0).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Karnofsky performance status of ≥50 (or ECOG/WHO equivalent).
- Age > 18 years .
- Ability to understand a written informed consent document, and the willingness to sign it.
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).
- Post radical prostatectomy (RP) - AUA recommendation, PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
- 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
- Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282137
|Contact: Susan Cork||713-781-6200 ext 3203||Scork@exceldiagnostics.com|
|Contact: Rodolfo Nunez, MD||713-781-6200 ext 3225||Rnunez@exceldiagnostics.com|
|United States, Texas|
|Radio- Isotope Therapy of America||Recruiting|
|Houston, Texas, United States, 77042|
|Contact: Susan Cork 713-341-3203 email@example.com|
|Contact: Ayman Gaber, MBBCh-MS 713-781-6200 ext 3242 firstname.lastname@example.org|
|Principal Investigator: Rodolfo Nunez, MD|
|Sub-Investigator: Ebrahim S Delpassand, MD-FACNM|
|Sub-Investigator: Ayman Gaber, MBBCh-MS|
|Principal Investigator:||Rodolfo Nunez, MD||Excel Diagnostics and Nuclear Oncology Center|
|Responsible Party:||Ebrahim Delpassand, Chairman and Medical Director, Radio Isotope Therapy of America|
|Other Study ID Numbers:||
IND124388 ( Other Identifier: US Food and Drug Administration )
|First Posted:||November 4, 2014 Key Record Dates|
|Last Update Posted:||August 19, 2020|
|Last Verified:||August 2020|
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