SBRT with PSMA PET/MR for Prostate Cancer

(PSMA SBRT-SIB Trial)

Overseen By Dakota Trick

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Must not be taking: Abiraterone

Disqualifiers: Metastatic disease, Prostate size, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1-2 weeks

50 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{4 7 8 9 10}

Research Team

Silvia Formenti, M.D.

Principal Investigator

Weill Medical College of Cornell University

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.

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

Treatment Details

Interventions

• Gallium-68 labeled PSMA-HBED-CC
• Stereotactic Body Radiation Therapy (SBRT)

Trial Overview 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.

Participant Groups

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)

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Gallium-68 PSMA ligand (Ga-68 PSMA) is a promising PET tracer for detecting prostate cancer, showing excellent image quality and resolution in renal parenchyma during scans.

In a study of four prostate cancer patients, the tracer demonstrated normal distribution in two cases, while the other two showed renal cysts affecting the imaging, highlighting the importance of evaluating renal uptake in PET scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Gallium-68 Prostate-specific Membrane Antigen Ligand be a Potential Radiotracer for Renal Cortical Positron Emission Tomography Imaging? Sarikaya, I., Elgazzar, AH., Alfeeli, MA., et al.[2020]

The study involving 20 patients demonstrated that (68)Ga-PSMA PET/MRI is more effective than PET/CT for detecting recurrent prostate cancer, providing clearer images and better characterization of unclear findings.

PET/MRI resulted in lower radiation exposure compared to PET/CT, although it presented challenges in scatter correction and differences in standardized uptake values (SUVs) between the two imaging methods.

NCBI (Pubmed)

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. Afshar-Oromieh, A., Haberkorn, U., Schlemmer, HP., et al.[2022]

Gallium-68 labeled PSMA-ligands, particularly 68Ga-PSMA, show improved detection rates and specificity for prostate cancer compared to standard imaging methods, making it a promising tool for diagnosing both primary and recurrent disease.

While 68Ga-PSMA PET scans outperform conventional imaging techniques, especially in identifying disease at low PSA levels (< 1 ng/mL), the current evidence base is still underdeveloped, highlighting the need for more rigorous studies to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of 68Ga-PSMA PET/CT for Prostate Cancer Management at Initial Staging and Time of Biochemical Recurrence. Bailey, J., Piert, M.[2018]

68Ga-PSMA PET/CT is highly effective for detecting recurrent prostate cancer, identifying cancer sites in 81% of patients with rising PSA levels after treatment, and showing a 50% detection rate for PSA levels between 0.2-0.49 ng/ml.

The imaging method demonstrated no reported adverse effects, making it a safe option for patients, and it outperformed traditional imaging methods like bone scans in detecting early recurrence of prostate cancer.

NCBI (Pubmed)

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. von Eyben, FE., Picchio, M., von Eyben, R., et al.[2022]

The study highlights the imaging characteristics of a metastatic superscan using gallium-68-PSMA PET/CT, a new radiotracer being tested for prostate cancer imaging.

This imaging technique was used to assess a patient with extensive bone metastases, indicating its potential role in evaluating candidates for targeted therapies like Lu-177-PSMA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic superscan in prostate carcinoma on gallium-68-prostate-specific membrane antigen positron emission tomography/computed tomography scan. Agarwal, KK., Tripathi, M., Kumar, R., et al.[2020]

Gallium-68 can be effectively used to radiolabel high-affinity inhibitors of prostate-specific membrane antigen (PSMA), achieving high yields (60-70%) and excellent purity (>99%).

The compounds [(68)Ga]3 and [(68)Ga]6 demonstrated significant tumor uptake in PSMA+ tumors, with clear delineation of tumors in PET imaging, indicating their potential for precise cancer imaging without the need for a cyclotron.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-labeled inhibitors of prostate-specific membrane antigen (PSMA) for imaging prostate cancer. Banerjee, SR., Pullambhatla, M., Byun, Y., et al.[2022]

(68)Ga-PSMA PET/CT is a highly sensitive diagnostic tool for detecting primary prostate cancer and its metastases, outperforming traditional fluorine-18 choline PET/CT by identifying more metastases at lower PSA levels.

The (68)Ga-PSMA radioligand can be produced in hospitals using a gallium generator, making it a convenient and accessible option for prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Lavalaye, J., Lam, MG., Verzijlbergen, JF., et al.[2021]

99mTechnetium labeled PSMA SPECT-CT imaging is a cost-effective and simpler alternative to Gallium-68 PSMA PET-CT for diagnosing prostate cancer, including detecting primary tumors and metastases.

The study presents a case showing the use of 99mTc-PSMA imaging before therapy and 177Lu-PSMA imaging after therapy, highlighting the potential for effective monitoring of treatment response in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tc-99m PSMA and Lu-177 PSMA Theranostic Pair in a Patient of Metastatic Castration Resistant Prostate Cancer. Sheikh, N., Younis, MN., Mumtaz, M., et al.[2022]

In a study of 144 patients, 68Ga-PSMA PET/CT showed a slightly lower sensitivity (83.1%) compared to mpMRI (90.1%) for detecting prostate cancer lesions, but it was more effective at identifying larger lesions that mpMRI missed.

68Ga-PSMA PET/CT provided additional detection of prostate cancer lesions, identifying 13.5% more index lesions and 18.2% more total lesions compared to mpMRI, suggesting it offers incremental value in the diagnostic process for prostate cancer.

NCBI (Pubmed)

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? Donato, P., Morton, A., Yaxley, J., et al.[2021]

(68)Gallium (Ga)-PSMA PET/CT scans are now being used in clinical practice in the Netherlands for prostate cancer, showing potential advantages over traditional imaging methods.

However, there is currently insufficient evidence to fully establish the effectiveness of Ga-PSMA PET/CT scans for both initial diagnosis and recurrent disease, highlighting the need for further well-designed studies to clarify their role and impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Introduction of PSMA PET requires thorough research]. de Reijke, TM., van Moorselaar, JR.[2019]

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]

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]

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]

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]

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]

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

68Ga-labeled inhibitors of prostate-specific membrane antigen (PSMA) for imaging prostate cancer. [2022]

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

[Not Available]. [2021]

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]

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]

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

[Introduction of PSMA PET requires thorough research]. [2019]