SBRT with PSMA PET/MR for Prostate Cancer

(PSMA SBRT-SIB Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Josephine Kang, M.D.,Ph.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Weill Medical College of Cornell University

Must not be taking: Abiraterone

Disqualifiers: Metastatic disease, Prostate size, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a single-arm Phase II clinical trial assessing the clinical efficacy of prostate specific membrane antigen (PSMA) PET/MR guided MR-LINAC based SBRT-SIB with planned accrual of 50 patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on or planning to take abiraterone, you cannot participate.

What data supports the effectiveness of this treatment for prostate cancer?

Research shows that Gallium-68 labeled PSMA ligands are promising for imaging prostate cancer, helping doctors see the cancer more clearly and potentially improving treatment decisions.

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Is the treatment using Gallium-68 labeled PSMA safe for humans?

The research articles do not provide specific safety data for Gallium-68 labeled PSMA in humans, but they do describe its use as a promising imaging tool for prostate cancer, indicating it is being actively studied and used in clinical settings.

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How is the treatment SBRT with PSMA PET/MR for prostate cancer different from other treatments?

This treatment is unique because it combines a special imaging technique using Gallium-68 labeled PSMA, which helps to precisely locate prostate cancer cells, with Stereotactic Body Radiation Therapy (SBRT), a highly focused form of radiation therapy. This combination allows for more accurate targeting of cancer cells, potentially improving treatment outcomes compared to traditional methods.

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Eligibility Criteria

Men over 21 with high-risk prostate cancer (Gleason score 8-10, PSA over 20 ng/ml, or advanced tumor stage) or unfavorable intermediate risk. Participants must not have metastatic disease and agree to use birth control after PSMA injections. Exclusions include contraindications to PSMA IV or SBRT, large prostate size, high AUA score, prior radiation treatment to the prostate, abiraterone usage.

Inclusion Criteria

My cancer has not spread to other parts of my body or lymph nodes.

I am a man aged 21 or older.

Ability to provide signed informed consent and willingness to comply with protocol requirements.

Exclusion Criteria

I have no medical reasons preventing me from undergoing prostate SBRT.

I have no health issues preventing me from receiving PSMA IV treatments.

I am not taking and do not plan to take abiraterone.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Planning

Participants undergo PSMA PET/MR imaging prior to the start of radiation treatment planning

1-2 weeks

1 visit (in-person)

Treatment

Participants receive stereotactic body radiation therapy (SBRT) in 5 sessions

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Multiple visits at 1 month, 6 months, 12 months, 18 months, and 24 months

Participant Groups

This Phase II trial is testing a targeted radiation therapy guided by PSMA PET/MR imaging in men with high-intermediate and high-risk prostate cancer. The study aims to enroll 50 patients who will receive Stereotactic Body Radiation Therapy (SBRT) with an integrated boost directed by advanced imaging techniques.

Group I: Single Arm Experimental Treatment 2 Interventions

Patients enrolling on the protocol will undergo prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance(MR) prior to start of the radiation treatment planning process. PSMA tracer is administered by IV injection and PET images are acquired. Any patients found to have possible metastatic disease will undergo a standard of care confirmatory biopsy (if feasible) and receive treatment appropriate for their stage. The PSMA PET/MR scan will be performed prior to initiation of androgen deprivation therapy (ADT).

Gallium-68 labeled PSMA-HBED-CC is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Illuccix for:

• Primary staging of patients with high-risk or suspected metastatic prostate cancer
• Suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels
• Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC)

🇪🇺 Approved in European Union as Locametz for:

• Primary staging of patients with high-risk or suspected metastatic prostate cancer
• Suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels
• Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Weill Cornell Medicine New York, NY

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. Germany pubmed.ncbi.nlm.nih.gov

Can Gallium-68 Prostate-specific Membrane Antigen Ligand be a Potential Radiotracer for Renal Cortical Positron Emission Tomography Imaging? [2020] Gallium-68 prostate-specific membrane antigen (Ga-68 PSMA) ligand (HBED-CC) is a new promising positron emission tomography (PET) tracer for prostate cancer. Intense renal parenchymal uptake is a physiologic finding on Ga-68 PSMA ligand PET images. Evaluation of kidneys in low intensity demonstrates excellent distribution of this radiotracer in renal parenchyma with excellent image quality and resolution. In this article, we present the Ga-68 PSMA ligand PET renal images of four patients with prostate cancer. In two patients, there is normal distribution of radiotracer, and in other two, there are renal cysts causing parenchymal defects.

2. Germany pubmed.ncbi.nlm.nih.gov

Comparison of PET/CT and PET/MRI hybrid systems using a 68Ga-labelled PSMA ligand for the diagnosis of recurrent prostate cancer: initial experience. [2022] (68)Ga-labelled HBED-CC-PSMA is a highly promising tracer for imaging recurrent prostate cancer (PCa). The intention of this study was to evaluate the feasibility of PET/MRI with this tracer.

3. United States pubmed.ncbi.nlm.nih.gov

Performance of 68Ga-PSMA PET/CT for Prostate Cancer Management at Initial Staging and Time of Biochemical Recurrence. [2018] Label="PURPOSE OF THE REVIEW" NlmCategory="OBJECTIVE">Recently introduced Gallium-68 labeled PSMA-ligands such as HBED-CC (68Ga-PSMA) have shown promise for unmet diagnostic needs in prostate cancer.

4. Netherlands pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Computed Tomography for Prostate Cancer: A Systematic Review and Meta-analysis. [2022] Label="CONTEXT"> 68Gallium prostate-specific membrane antigen (PSMA) ligand 68Ga-HBED-CC-PSMA (68Ga-PSMA) is a promising radiotracer for positron emission tomography (PET)/computed tomography (CT) of prostate cancer.

5. India pubmed.ncbi.nlm.nih.gov

Metastatic superscan in prostate carcinoma on gallium-68-prostate-specific membrane antigen positron emission tomography/computed tomography scan. [2020] We describe the imaging features of a metastatic superscan on gallium-68 Glu-NH-CO-NH-Lys-(Ahx)-[Ga-68(HBED-CC)], abbreviated as gallium-68-prostate-specific membrane antigen ((68)Ga-PSMA) positron emission tomography/computed tomography (PET/CT) imaging. (68)Ga-PSMA is novel radiotracer undergoing evaluation for PET/CT imaging of prostate carcinoma. This patient had a superscan of metastases on conventional bone scintigraphy and was referred for (68)Ga-PSMA PET/CT to evaluate the feasibility of (177)Lu-PSMA therapy.

6. United States pubmed.ncbi.nlm.nih.gov

68Ga-labeled inhibitors of prostate-specific membrane antigen (PSMA) for imaging prostate cancer. [2022] Gallium-68 is a generator-produced radionuclide for positron emission tomography (PET) that is being increasingly used for radiolabeling of tumor-targeting peptides. Compounds [(68)Ga]3 and [(68)Ga]6 are high-affinity urea-based inhibitors of the prostate-specific membrane antigen (PSMA) that were synthesized in decay-uncorrected yields ranging from 60% to 70% and radiochemical purities of more than 99%. Compound [(68)Ga]3 demonstrated 3.78 +/- 0.90% injected dose per gram of tissue (%ID/g) within PSMA+ PIP tumor at 30 min postinjection, while [(68)Ga]6 showed a 2 h PSMA+ PIP tumor uptake value of 3.29 +/- 0.77 %ID/g. Target (PSMA+ PIP) to nontarget (PSMA- flu) ratios were 4.6 and 18.3, respectively, at those time points. Both compounds delineated tumor clearly by small animal PET. The urea series of imaging agents for PSMA can be radiolabeled with (68)Ga, a cyclotron-free isotope useful for clinical PET studies, with maintenance of target specificity.

7. Netherlands pubmed.ncbi.nlm.nih.gov

[Not Available]. [2021] (68)Gallium (Ga)-PSMA PET/CT (PSMA stands for "prostate-specific membrane antigen") is a new diagnostic tool for patients with prostate cancer or with prostate cancer metastases. PET/CT is a combination scan which uses the physiological information of the PET scan and the anatomic information of the CT scan. The radioligand (68)Ga-PSMA is a radioactively labelled peptide that binds to the membrane protein PSMA. Prostate cancer cells in the primary tumour and in metastases express increased levels of PSMA in the plasma membrane. A number of studies have shown that (68)Ga-PSMA PET/CT is sensitive in detecting primary prostate cancer and metastases in lymph nodes and bone. In the same patient, (68)Ga-PSMA PET/CT detects more metastases in an earlier phase, i.e. at a lower PSA level, than fluorine-18 choline PET/CT. Furthermore, the (68)Ga-PSMA can be produced in the investigating hospital with a gallium generator. The expectation is that the use of (68)Ga-PSMA PET/CT will increase to a major extent over the coming years in patients with prostate cancer.

8. Pakistan pubmed.ncbi.nlm.nih.gov

Tc-99m PSMA and Lu-177 PSMA Theranostic Pair in a Patient of Metastatic Castration Resistant Prostate Cancer. [2022] Prostate specific membrane antigen (PSMA) targeted PET-CT imaging labeled with Gallium-68 (68Ga) is a standard diagnostic investigation in patients of carcinoma of prostate, for detection of primary tumour, initial staging of high risk disease for metastases as well as detection of recurrence. 99mTechnetium labeled PSMA SPECT-CT is a more cost-effective and logistically simple alternative for it. We present pre-therapy images of 99mTc-PSMA and post-therapy scan with 177Lu- PSMA in the same patient.

9. Germany pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT better characterises localised prostate cancer after MRI and transperineal prostate biopsy: Is 68Ga-PSMA PET/CT guided biopsy the future? [2021] 68Ga prostate specific membrane antigen PET/CT (68Ga-PSMA PET/CT) may be superior to multiparametric MRI (mpMRI) for localisation of prostate cancer tumour foci, however the concordance and differences between 68Ga-PSMA PET/CT and mpMRI when applied to all biopsied patients and potential benefit in patients with negative mpMRI is unclear.

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Introduction of PSMA PET requires thorough research]. [2019] (68)Gallium (Ga)-PSMA PET/CT scans have been introduced in clinical practice in the Netherlands too. Although there are some indications that this new imaging modality for prostate cancer might be superior to other techniques, evidence is lacking both for primary diagnosis and in the case of recurrent disease. The exact role of the (68)Ga-PSMA PET/CT scan needs to be defined on the basis of well-designed studies that also evaluate the impact of earlier diagnosis on the outcome for the individual patient.