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M9241 + SBRT for Prostate Cancer

Phase 2
Recruiting
Led By Ravi A Madan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status < 2
Participants must have histologically or cytologically confirmed localized intermediate or high risk prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 4 weeks after end of treatment
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new drug (M9241) to see if it is safe and if it can help the immune system to fight prostate cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include typical reactions at injection sites like pain or swelling, possible flu-like symptoms such as fever or fatigue due to immune activation by M9241, organ inflammation risks from immunotherapy agents in general, and common radiation therapy side effects like skin irritation or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most of my daily activities without help.
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My prostate cancer is confirmed and is at an intermediate or high risk level.
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My organs and bone marrow are working well.
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I need SBRT and hormone therapy for my prostate cancer.
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I am a man aged 18 or older.
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My prostate cancer can be biopsied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks after start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and four weeks after start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine safety and tolerated doses of M9241 and SBRT
evaluate T-cell clonality as measures of immunologic activity
Secondary outcome measures
Evaluate peripheral immune response

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593
21%
Anemia
18%
Neutropenia
15%
Hypoalbuminemia
15%
White blood cell decreased ( leukopenia)
15%
Diarrhea
12%
Liver Dysfunction
9%
Hand-Foot
3%
Bleeding
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Edema
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gem + Xeloda + SBRT

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: 3/Arm 2bExperimental Treatment1 Intervention
SBRT
Group II: 2/Arm 2aExperimental Treatment2 Interventions
Highest tolerated dose of M941+SBRT
Group III: 1/Arm 1Experimental Treatment2 Interventions
De-escalating doses of M9241 if appropriate + SBRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~740

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,587 Previous Clinical Trials
41,242,437 Total Patients Enrolled
559 Trials studying Prostate Cancer
507,214 Patients Enrolled for Prostate Cancer
Ravi A Madan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
17 Previous Clinical Trials
973 Total Patients Enrolled
11 Trials studying Prostate Cancer
811 Patients Enrolled for Prostate Cancer

Media Library

Stereotactic Body Radiation Therapy (SBRT) Clinical Trial Eligibility Overview. Trial Name: NCT05361798 — Phase 2
Prostate Cancer Research Study Groups: 1/Arm 1, 2/Arm 2a, 3/Arm 2b
Prostate Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT05361798 — Phase 2
Stereotactic Body Radiation Therapy (SBRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361798 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can the trial accommodate in total?

"Affirmative. According to the information located on clinicaltrials.gov, this trial is currently enrolling participants and was initially announced on December 5th 2022; it has since been updated as of November 29th 2022. This study requires 65 patients from one medical site."

Answered by AI

Does this research trial have any active enrollment slots available?

"Clinicaltrials.gov presently displays this clinical trial's details, which were first published on December 5th 2022 and recently modified on November 29th of the same year."

Answered by AI

Is Stereotactic Body Radiation Therapy (SBRT) sanctioned by the FDA?

"There is some evidence suggesting Stereotactic Body Radiation Therapy (SBRT) may be safe, so it received a rating of 2. However, there are no studies to attest its efficacy as this trial is still in Phase 2."

Answered by AI
~25 spots leftby Aug 2024