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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: Recruiting Phase 2 study of Cancer Of Prostate, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
For the safety lead-in: grade and type of toxicities at each dose level will be assessed to determine safety and tolerated doses of PDS01ADC in combination with SBRT in participants with high and intermediate risk prostate cancer receiving standard of care ADT
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 |
What NCT05361798 shows while recruiting
NCT05361798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,930-participant average among 7 other Cancer Of Prostate trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
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