Prostate CancerPhase 2NCT04483414
68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer
A Phase 2 study testing 68Ga PSMA-11 injection and Positron Emission Tomography/Computed Tomography in people with Prostate Cancer and Prostate Cancer Metastatic, run by Dana Mathews at 1 site in United States.
Trial summary
The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to detect sites of recurrent prostate cancer in patients with biochemical recurrence previously treated with radical prostatectomy (RP) or… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Metastatic to Bone
- What is being tested?
- 68Ga PSMA-11 injection and Positron Emission Tomography/Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 5 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected BCR of prostate cancer following initial treatment with either prostatectomy or definitive EBRT of the prostate or patients with known metastatic prostate cancer who have failed systemic therapy.
- Patients being considered for salvage therapy.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Patients must be medically stable as judged by the patient's physician.
- Patients must be able to lie still for 20-40 minutes for the PET/CT scans.
- Ability to understand and the willingness to sign a written informed consent.
- Patients with BCR and no known lesions should not be on antiandrogen therapy at the time of scans. Patients with known metastases who are currently being treated with anti-androgen therapy may remain on this medication.
Who cannot join
- Patients who have or have had a biopsy proven concurrent other malignancy, excluding skin cancers.
- Patients may not weigh more than the maximum weight limit for the PET /CT scanner table (> 200 kg or 440 pounds).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11. Furosemide will not be administered to patients with known allergy.
- Patients must not be claustrophobic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of 68Gallium PSMA-11 in Biochemical Recurrence in Prostate Cancer and in Known Metastatic Prostate Cancer and in the Evaluation of Treatment Response After Salvage Therapy
The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to detect sites of recurrent prostate cancer in patients with biochemical recurrence previously treated with radical prostatectomy (RP) or external beam radiation (EBRT) and to assess treatment response to subsequent salvage therapy.
Read the detailed description
In developed countries, prostate cancer is the most common malignancy in men and the third leading cause of death in men. Following primary therapy for prostate cancer, a substantial number of patients will recur either locally in the pelvis or in extra pelvic locations. Approximately 20-30% of patients' status post RP will recur and up to 60% patients treated with EBRT will recur, as detected by rising serum levels of prostate specific antigen (PSA) after original therapy. This phenomenon is referred to as biochemical recurrence (BCR), as the elevated PSA usually occurs in advance of obvious clinical or radiologic evidence.
This study is designed to evaluate the performance of 68Ga PSMA-11 PET/CT in detecting the location (localized versus extra pelvic) of BCR and advanced metastatic prostate cancer compared to conventional imaging. In addition, we will evaluate its performance in assessing interim and post salvage therapy response compared to conventional imaging, including pelvic magnetic resonance imaging (MRI), computed tomography (CT), and bone scintigraphy.
- Being tested
- 68Ga PSMA-11 injection, Positron Emission Tomography/Computed Tomography
- Keywords
- PET/CT, prostate cancer, Gallium-68, PSMA-11
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga PSMA-11 injectionDrug
Injection of 68Ga PSMA-11
Positron Emission Tomography/Computed TomographyProcedure or surgery
Also called PET/CT
PET/CT scan after 68Ga PSMA-11 injection
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected BCR or metastatic prostate cancer | Experimental | Patients with suspected BCR or metastatic prostate cancer Receives: Drug: 68Ga PSMA-11 injection; Procedure: Positron Emission Tomography/Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Location of recurrence
Localized vs extra-pelvic recurrence will be determined for each patient based on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
Measured: Up to 3 years
Residual prostate cancer
For imaging during or after salvage therapy, existence of residual prostate cancer will be determined for each patient on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start19 Mar 2021
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Why it stopped: Study was closed since no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Unblinded, single arm imaging study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana Mathews
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dana Mathews, University of Texas Southwestern Medical Center
- Investigators
- Orhan K Oz, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483414
- Sponsor's protocol ID
- STU-2020-0488
- Status last verified
- May 2023
- First submitted
- 20 Jul 2020
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 68Gallium PSMA-11 in Biochemical Recurrence in Prostate Cancer and in Known Metastatic Prostate Cancer and in the Evaluation of Treatment Response After Salvage Therapy
- ClinicalTrials.gov ID
- NCT04483414
- Acronym / sponsor ID
- STU-2020-0488
- Keywords
- PET/CT, prostate cancer, Gallium-68, PSMA-11
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was closed since no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dana MathewsUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to detect sites of recurrent prostate cancer in patients with biochemical recurrence previously treated with radical prostatectomy (RP) or external beam radiation (EBRT) and to assess treatment response to subsequent salvage therapy.
Detailed description
In developed countries, prostate cancer is the most common malignancy in men and the third leading cause of death in men. Following primary therapy for prostate cancer, a substantial number of patients will recur either locally in the pelvis or in extra pelvic locations. Approximately 20-30% of patients' status post RP will recur and up to 60% patients treated with EBRT will recur, as detected by rising serum levels of prostate specific antigen (PSA) after original therapy. This phenomenon is referred to as biochemical recurrence (BCR), as the elevated PSA usually occurs in advance of obvious clinical or radiologic evidence.
This study is designed to evaluate the performance of 68Ga PSMA-11 PET/CT in detecting the location (localized versus extra pelvic) of BCR and advanced metastatic prostate cancer compared to conventional imaging. In addition, we will evaluate its performance in assessing interim and post salvage therapy response compared to conventional imaging, including pelvic magnetic resonance imaging (MRI), computed tomography (CT), and bone scintigraphy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Unblinded, single arm imaging study
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected BCR or metastatic prostate cancer | Experimental | Drug: 68Ga PSMA-11 injection, Procedure: Positron Emission Tomography/Computed TomographyPatients with suspected BCR or metastatic prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with suspected BCR of prostate cancer following initial treatment with either prostatectomy or definitive EBRT of the prostate or patients with known metastatic prostate cancer who have failed systemic therapy.
- Patients being considered for salvage therapy.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Patients must be medically stable as judged by the patient's physician.
- Patients must be able to lie still for 20-40 minutes for the PET/CT scans.
Key exclusion criteria (4 listed)
- Patients who have or have had a biopsy proven concurrent other malignancy, excluding skin cancers.
- Patients may not weigh more than the maximum weight limit for the PET /CT scanner table (> 200 kg or 440 pounds).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11. Furosemide will not be administered to patients with known allergy.
- Patients must not be claustrophobic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga PSMA-11 injectionInjection of 68Ga PSMA-11 | Drug | Patients with suspected BCR or metastatic prostate cancer |
| Positron Emission Tomography/Computed TomographyAlso: PET/CTPET/CT scan after 68Ga PSMA-11 injection | Procedure or surgery | Patients with suspected BCR or metastatic prostate cancer |
Primary outcome
Location of recurrence
Time frame: Up to 3 years
Localized vs extra-pelvic recurrence will be determined for each patient based on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
Residual prostate cancer
Time frame: Up to 3 years
For imaging during or after salvage therapy, existence of residual prostate cancer will be determined for each patient on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orhan K Oz, MD, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga PSMA-11 injection and Positron Emission Tomography/Computed Tomography in people with Prostate Cancer and Prostate Cancer Metastatic, run by Dana Mathews at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Location of recurrence (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.