M9241 + SBRT for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Ravi A Madan, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: National Cancer Institute (NCI)

Must be taking: ADT

Must not be taking: Systemic corticosteroids, Immunosuppressive medications

Disqualifiers: Metastatic disease, Previous prostatectomy, Autoimmune diseases, HIV, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Background: Prostate cancer is often treated with radiation and ADT (ADT is androgen deprivation therapy). Up to 30% of these cancers recur within 5 years of treatment. Researchers want to see if a new drug (M9241) can help the immune system to fight prostate cancer. Objective: To find what doses of M9241 are safe in people who are treated for prostate cancer. Also, to see what effects M9241 has on the immune system. Eligibility: People aged 18 and older with high- and intermediate-risk prostate cancer. Their cancer must not have spread to other parts of the body. Design: The study will last 7 months. Participants will be screened. They will share their medical history. They will also have: \<TAB\>A physical exam \<TAB\>Routine blood and urine tests \<TAB\>Imaging scans of the chest, abdomen, and pelvis \<TAB\>A bone scan \<TAB\>A tumor biopsy \<TAB\>A specialized MRI. Participants will lie face down on the MRI scanner table. An antenna that receives a signal may be placed in the rectum. All participants will be treated with radiation therapy and ADT. Some participants will also receive M9241 as an injection under the skin. This treatment will start 4 weeks after the radiation has ended. Participants will receive a total of 3 doses. The injections will be 4 weeks apart. Some screening tests will be repeated at each visit. Participants who do not receive M9241 will also have screening tests during the treatment period. Participants will return for follow-up about 1 month after the last treatment or set of tests.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or immunosuppressive medications, you may need to adjust your treatment, as these are generally not allowed unless they are low-dose or inhaled steroids.

What data supports the effectiveness of the treatment M9241 + SBRT for Prostate Cancer?

Research shows that stereotactic body radiation therapy (SBRT) is increasingly used and considered safe and effective for treating low- and intermediate-risk prostate cancer, with studies reporting positive patient-reported quality of life outcomes. However, evidence for its use in high-risk prostate cancer is less solid, and there is no direct data on the combination with M9241. ^{1 2 3 4 5}

Is the combination of M9241 and SBRT safe for humans?

Stereotactic body radiation therapy (SBRT) has been shown to be safe for treating prostate cancer, with studies confirming its safety and effectiveness. However, specific safety data for the combination of M9241 (also known as NHS-IL12) with SBRT is not provided in the available research. ^{6 7 8 9 10}

How is the treatment M9241 + SBRT for prostate cancer different from other treatments?

The treatment M9241 + SBRT for prostate cancer is unique because SBRT delivers high-dose radiation in fewer sessions (usually 5 or less), making it a shorter and more convenient option compared to traditional radiotherapy, which requires many more sessions. This approach may offer radiobiologic advantages and improved survival outcomes for certain prostate cancer patients. ^{3 11 12 13 14}

Eligibility Criteria

Men over 18 with intermediate or high-risk prostate cancer that hasn't spread are eligible. They need to have certain levels of blood cells, liver and kidney function, and agree to use contraception. Excluded are those with HIV, active hepatitis, other recent cancers (except some skin/cervical/breast/prostate), previous prostate treatments, immune deficiencies/autoimmune diseases, allergies to M9241 or SBRT contraindications.

Inclusion Criteria

My prostate cancer can be biopsied.

I am a man aged 18 or older.

Testosterone greater than 100 ng/dL

Exclusion Criteria

I don't have conditions like inflammatory bowel disease that prevent SBRT.

I have started hormone therapy or radiation treatment before joining this trial.

I haven't had any cancer except for treatable ones in the last 3 years.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Radiation Therapy

Participants receive Stereotactic Body Radiation Therapy (SBRT) along with Androgen Deprivation Therapy (ADT)

4 weeks

Weekly visits (in-person)

Immunotherapy Treatment

Participants receive M9241 injections every 4 weeks for 3 doses, starting 4 weeks after radiation ends

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• M9241 (Immunocytokine)
• Stereotactic Body Radiation Therapy (SBRT) (Radiation)

Trial Overview The trial tests if the drug M9241 can boost the immune system against prostate cancer when added to standard radiation therapy and ADT. Participants will receive either just radiation and ADT or these plus three doses of M9241 injections after radiation ends. The study lasts 7 months with follow-ups for safety and effectiveness.

Participant Groups

Group I: 3/Arm 2b Experimental Treatment 1 Intervention

SBRT

Group II: 2/Arm 2a Experimental Treatment 2 Interventions

Highest tolerated dose of M941+SBRT

Group III: 1/Arm 1 Experimental Treatment 2 Interventions

De-escalating doses of M9241 if appropriate + SBRT

Stereotactic Body Radiation Therapy (SBRT) is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

🇪🇺 Approved in European Union as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

🇯🇵 Approved in Japan as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

National Institutes of Health Clinical Center Bethesda, MD

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References

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

Prostate Stereotactic Body Radiation Therapy With a Focal Simultaneous Integrated Boost: 5-Year Toxicity and Biochemical Recurrence Results From a Prospective Trial. [2023] Stereotactic body radiation therapy (SBRT) is increasingly used as a definitive treatment option for patients with prostate adenocarcinoma. The aim of this study was to assess the late toxicity, patient-reported quality of life outcomes, and biochemical recurrence rates after prostate SBRT with simultaneous integrated boost (SIB) targeting lesions defined by magnetic resonance imaging (MRI).

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

Overview of the current role of stereotactic body radiotherapy in the treatment of unfavorable intermediate- and high-risk prostate cancer. [2023] Stereotactic body radiotherapy (SBRT) is well accepted for low- and intermediate-favorable risk prostate cancer. Available evidence about the application of SBRT in unfavorable- and high-risk prostate cancer is less solid. During last year's multiple variations in treatment, techniques have been reported making comparisons more complicated. This review's objective is to review current evidence in application of SBRT in intermediate unfavourable and high-risk prostate cancer and to outline variations in SBRT treatment techniques and relevant results.

3. Italy pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy in castration-resistant prostate cancer patients with oligoprogression during androgen receptor-targeted therapy. [2021] To report outcomes of stereotactic body radiotherapy (SBRT) in metastatic castration-resistant prostate cancer (mCRPC) patients with oligoprogression (≤ 5 metastases) during first-line treatment with androgen receptor-targeted therapy (ARTT).

4. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design? [2020] Stereotactic body radiation therapy (SBRT) is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding the appropriate patient-reported outcome (PRO) endpoints for clinical trials evaluating radiation modalities for early stage prostate cancer is lacking. To aid in clinical trial design, this study presents PROs over a 36-month period following SBRT for clinically localized prostate cancer.

5. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy with flattening filter-free beams for prostate cancer: assessment of patient-reported quality of life. [2021] Stereotactic body radiotherapy (SBRT) is an emerging treatment approach reported as safe and effective strategy for low- and intermediate-risk prostate cancer patients. End point of the current study is to appraise the patient-reported quality of life according to the expanded prostate cancer index composite (EPIC) questionnaire.

6. China pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. [2022] To explore the efficacy and toxicity of stereotactic body radiation therapy (SBRT) versus conventional intensity-modulated radiation therapy (IMRT) in the treatment of prostate cancer.

7. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021] The safety and efficacy of stereotactic body radiotherapy (SBRT) in localised prostate cancer are now established through phase III randomised trials. Its utility in node-positive prostate cancer is restricted due to a lack of controlled studies specifically addressing this subgroup. Herein we report the safety and efficacy of SBRT in this subgroup.

8. Ireland pubmed.ncbi.nlm.nih.gov

Patient-reported quality of life after stereotactic body radiotherapy (SBRT), intensity modulated radiotherapy (IMRT), and brachytherapy. [2022] Stereotactic body radiotherapy (SBRT) is being used for prostate cancer, but concerns persist about toxicity compared to other radiotherapy options.

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

Early Tolerance Outcomes of Stereotactic Hypofractionated Accelerated Radiation Therapy Concomitant with Pelvic Node Irradiation in High-risk Prostate Cancer. [2022] This study aimed to evaluate the toxicity of prostate and pelvic lymph node stereotactic body radiation therapy (SBRT) for high-risk prostate cancer.

10. England pubmed.ncbi.nlm.nih.gov

Current use of stereotactic body radiation therapy for low and intermediate risk prostate cancer: A National Cancer Database Analysis. [2021] Recent studies have demonstrated both safety and efficacy of stereotactic body radiation therapy (SBRT) as monotherapy in the treatment of low and intermediate risk prostate cancer. Our study aims to provide an update analyzing the use of SBRT compared with conventional and hypofractionated regimens in the United States from 2004 to 2015.

11. England pubmed.ncbi.nlm.nih.gov

A phase II trial of stereotactic body radiotherapy in 4 fractions for patients with localized prostate cancer. [2022] To report results from our phase II study of stereotactic body radiotherapy (SBRT) delivering 36 Gy in 4 fractions for patients with localized prostate cancer.

12. Netherlands pubmed.ncbi.nlm.nih.gov

Highly hypofractionated schedules for localized prostate cancer: Recommendations of the GETUG radiation oncology group. [2022] Stereotactic body radiotherapy (SBRT) has become treatment option for localized prostate cancer but the evidence base remains incomplete. Several clinical studies, both prospective and retrospective, have been published. However, treatment techniques, target volumes and dose constraints lack consistency between studies. Based on the current available literature, the French Genito-Urinary Group (GETUG) suggests that.

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

Propensity-Weighted Survival Analysis of SBRT vs. Conventional Radiotherapy in Unfavorable Intermediate-Risk Prostate Cancer. [2023] Prostate stereotactic body radiotherapy (SBRT), which delivers high-dose precision treatment in ≤5 fractions, is a shorter, more convenient, and less expensive alternative to conventionally fractionated radiotherapy (CRFT; ∼44 fractions) or moderately hypofractionated radiotherapy (MFRT; 20-28 fractions). SBRT has not been widely adopted but may have radiobiologic advantages over CFRT/MFRT. We hypothesized that SBRT would be associated with improved overall survival (OS) versus CFRT or MFRT ± androgen deprivation therapy (ADT) for unfavorable-intermediate-risk prostate cancer (UIR-PCa).

14. Germany pubmed.ncbi.nlm.nih.gov

The march toward single-fraction stereotactic body radiotherapy for localized prostate cancer-Quo Vadimus? [2023] Stereotactic body radiotherapy (SBRT) is an emerging treatment option for localized prostate cancer. There is increasing interest to reduce the number of fractions for prostate SBRT.