Prostate AdenocarcinomaPhase 2NCT03204123
PSMA PET Imaging of Recurrent Prostate Cancer
A Phase 2 study testing Ga-HBED-iPSMA PET, PET/CT and MRI in people with Prostate Adenocarcinoma and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Prostate Cancer
- What is being tested?
- Ga-HBED-iPSMA PET, PET/CT and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,171 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Jun 2017to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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:
Show all 9Show fewer
- ° 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
Who cannot join
- Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553
About this study
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.
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer
- Being tested
- Ga-HBED-iPSMA PET, PET/CT, MRI
- Keywords
- prostate cancer, prostatectomy, biochemical recurrence, Ga-HBED-iPSMA, 16-306
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-HBED-iPSMA PETDrug
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/CTDiagnostic 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.
MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Ga-HBED-iPSMA PET with CT or MRI | Active comparator | 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. Receives: Drug: Ga-HBED-iPSMA PET; Diagnostic Test: PET/CT; Diagnostic Test: MRI |
| Ga-HBED-iPSMA PET with MRI | Active comparator | 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. Receives: Drug: Ga-HBED-iPSMA PET; Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease localization by PSMA PET/MR
Measured: 2 years
Secondary outcomes (2)
PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT
Measured: 2 years
Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start26 Jun 2017
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heiko Schöder, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204123
- Sponsor's protocol ID
- 16-306
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2017
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA PET Imaging of Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT03204123
- Acronym / sponsor ID
- 16-306
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer
- Keywords
- prostate cancer, prostatectomy, biochemical recurrence, Ga-HBED-iPSMA, 16-306
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,171 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Jun 2017 (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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ga-HBED-iPSMA PET with CT or MRI | Active comparator | Drug: Ga-HBED-iPSMA PET, Diagnostic Test: PET/CT, Diagnostic Test: MRIParticipants 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 | Active comparator | Drug: Ga-HBED-iPSMA PET, Diagnostic Test: MRIParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- For patients who have received additional treatment in the recurrent or metastatic setting:
- ° PSA ≥ 2 ng/ml above the most recent therapy nadir
Key exclusion criteria (1 listed)
- Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.
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 |
|---|---|---|
| Ga-HBED-iPSMA PETPatients 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. | Drug | Ga-HBED-iPSMA PET with CT or MRI, Ga-HBED-iPSMA PET with MRI |
| PET/CTPET/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. | Diagnostic test | Ga-HBED-iPSMA PET with CT or MRI |
| MRIPatients may undergo a diagnostic MRI of the prostate, other body parts or a whole-body MRI at the same imaging session as clinically indicated. | Diagnostic test | Ga-HBED-iPSMA PET with CT or MRI, Ga-HBED-iPSMA PET with MRI |
Primary outcome
Disease localization by PSMA PET/MR
Time frame: 2 years
2 secondary outcomes
PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Prostate Adenocarcinoma
RecruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Heiko Schöder, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ga-HBED-iPSMA PET, PET/CT and MRI in people with Prostate Adenocarcinoma and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 9 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Disease localization by PSMA PET/MR (time frame: 2 years). 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 26 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.