Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05361798 · ClinicalTrials.gov registry record · Phase 2
T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High- and Intermediate-Risk Prostate Cancer Treated With Androgen Deprivation Therapy
A Phase 2 study of Cancer Of Prostate, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT05361798 is a Phase 2 study of Cancer Of Prostate that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 65 participants, below the 1,930-participant average among 7 other Cancer Of Prostate trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05361798, a Phase 2 study of Cancer Of Prostate, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
- DRUG M9241
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2023-06-12 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05361798
The ClinicalTrials.gov registry entry for NCT05361798 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,930-participant average among 7 other Cancer Of Prostate trials with a reported enrollment target (97% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cancer Of Prostate appearing as the primary indexed condition, and to 2 interventions - of which Stereotactic Body Radiation Therapy (SBRT) is the first listed.
NCT05361798 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05361798 about?
NCT05361798 is a clinical study titled "T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High- and Intermediate-Risk Prostate Cancer Treated With Androgen Deprivation Therapy". 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...
What is the current status of trial NCT05361798?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2023-06-12. Estimated completion is 2026-12-01.
What conditions does trial NCT05361798 study?
This clinical trial studies the following conditions: Cancer Of Prostate.
What interventions are being tested in trial NCT05361798?
The interventions under investigation include: Stereotactic Body Radiation Therapy (SBRT) (RADIATION), M9241 (DRUG).
Who is sponsoring clinical trial NCT05361798?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05361798 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cancer Of Prostate
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Collection of Blood From Patients With Prostate Cancer
RECRUITING
-
A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer
RECRUITING · Phase 1
-
Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer
RECRUITING
-
Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer
RECRUITING · Phase 1
-
Onco-primary Care Networking to Support TEAM-based Care
ACTIVE NOT RECRUITING · NA
-
North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)
COMPLETED
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.