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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating prostate cancer using advanced imaging and radiation therapy. The goal is to determine how effectively a special scan, called PSMA PET/MR, can guide precise radiation treatment for men with high-risk prostate cancer. This involves a combination of an injected tracer (Gallium-68 labeled PSMA-HBED-CC) and targeted radiation (Stereotactic Body Radiation Therapy, or SBRT). Men diagnosed with high-risk prostate cancer, such as those with a PSA level of 20 or higher, might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Gallium-68 labeled PSMA-HBED-CC used in this trial is generally safe for people with prostate cancer. In studies, it was used in PET scans to detect cancer cells, and no major safety issues emerged. The FDA has approved this treatment for imaging, confirming its safety for this use.

Studies indicate that Stereotactic Body Radiation Therapy (SBRT) is a safe method for treating prostate cancer. Many patients tolerate it well, with manageable side effects like urinary problems, which are less severe than those from traditional radiation. Most people complete their treatment without major issues.

Overall, both treatments in this trial have been well-tolerated by people with prostate cancer, suggesting they are safe options for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments for prostate cancer?

Researchers are excited about the treatment combining Gallium-68 labeled PSMA-HBED-CC and Stereotactic Body Radiation Therapy (SBRT) for prostate cancer because it offers a cutting-edge approach to pinpointing and treating cancer cells. Unlike traditional methods that rely heavily on broad-spectrum imaging, this treatment uses a PSMA PET/MR scan to precisely identify cancerous areas, potentially leading to more accurate targeting during radiation therapy. This enhanced precision could mean fewer side effects and improved outcomes for patients. Additionally, by using the PSMA tracer, it targets prostate-specific membrane antigens, which is a new mechanism that could more effectively address prostate cancer than conventional therapies.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that a special imaging agent, Gallium-68 labeled PSMA-HBED-CC, effectively detects prostate cancer, particularly if it recurs after treatment. This agent identifies cancer in the prostate area and any spread to other body parts, aiding doctors in planning more precise treatments. In this trial, participants will undergo PSMA PET/MR imaging with Gallium-68 labeled PSMA-HBED-CC before starting radiation treatment planning.

Stereotactic Body Radiation Therapy (SBRT) shows promise for treating prostate cancer. One study found that 83.6% of patients who received SBRT did not experience cancer progression over five years. It also alleviates symptoms without causing severe side effects. In this trial, SBRT will manage prostate cancer more effectively, guided by the precise imaging provided by Gallium-68 labeled PSMA-HBED-CC. ^{3 4 5 6 7}

Who Is on the Research Team?

Silvia Formenti, M.D.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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)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]

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]

(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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30350010/

68Ga-PSMA-11 PET/CT in recurrent prostate cancer Our data confirmed the efficacy of 68 Ga-PSMA-11 PET/CT for detecting local vs systemic disease in PCa patients presenting PSA failure after radical therapy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03396874

Study Details | NCT03396874 | Gallium-68 PSMA-11 PET ... This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, ...

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.233460

Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in ... Visual 68 Ga-PSMA-11 PET/CT eligibility criteria helped identify participants with metastatic castration-resistant prostate cancer who benefitted from 177 Lu- ...

4. mayoclinic.org mayoclinic.org/drugs-supplements/gallium-ga-68-psma-11-intravenous-route/description/drg-20506366

Gallium ga 68 psma-11 (intravenous route) - Side effects & ... Gallium Ga 68 PSMA-11 injection is used with a PET scan (positron emission tomography) of prostate-specific membrane antigen (PSMA) positive lesions in ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/63/2/240

Diagnostic Performance and Clinical ... This multicenter, international, prospective trial of PSMA PET/CT confirmed its capability for detecting local and metastatic recurrence in most PCa patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8401928/

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga ... ... 68Ga-labeled radiopharmaceutical for PET imaging of PSMA-positive prostate cancer. ... PSMA HBED-CC PET/MRI Improves the Localization of Primary Prostate Cancer.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/212642s000lbl.pdf

Gallium Ga 68 PSMA-11 Injection, for intravenous use The safety and efficacy of Ga 68 PSMA-11 Injection were established in two prospective, open-label studies (PSMA-PreRP and PSMA-BCR) in men with prostate cancer ...