RECRUITING

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

Conditions

Cancer Of Prostate Immunotherapy + Radiation Combination Therapy Nhs-Il 12

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Study Evaluating 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

Quick Facts

Study Start:2023-06-12

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05361798

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants must have histologically or cytologically confirmed localized intermediate or high risk prostate cancer: * Intermediate risk - Gleason 7 disease, PSA less than 10 * High Risk - Gleason 8-10, PSA\>10, Extracapsular Extension * Participants must require treatment with SBRT to the prostate and ADT. * Pre-treatment tissue availability (collected \<= 1 year to initiation of study therapy) for biomarker analysis is mandatory for enrollment. If tissue is determined to be of insufficient/unsuitable quality/quantity, a pre-treatment biopsy prior to initiation of study therapy will be required. * Male age \>= 18 years old * ECOG performance status \< 2 * Participants must have adequate organ and marrow function as defined below: * absolute neutrophil count \>= 1,500/mcL, without CSF support * platelets \>= 100,000/mcL * AST(SGOT)/ALT(SGPT) \<= 2.5 X institutional upper limit of normal * Hgb \>= 10g/dL (pRBC transfusions are not allowed to achieve acceptable Hgb) * Total bilirubin \<= 1.5 x upper limit of normal (ULN), * Serum albumin \>= 2.8 g/dL * Creatine \<= 1.5 X institutional ULN * Creatinine clearance \>= 50 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal by 24h urine * PT/INR and aPTT \<= 1.5 X institutional ULN * Testosterone greater than 100 ng/dL. * Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for 6 months after completion of radiation treatment or immunotherapy (if taken, whatever is last) * Participants must have prostate cancer accessible for biopsy * Ability of participant to understand and the willingness to sign a written informed consent document.	* Evidence of distant metastatic disease (including clinically or pathologically positive lymph nodes or metastatic disease outside of the pelvis). * Previous prostatectomy, focal therapy, or radiation to the prostate. Note: Previous finasteride, dutasteride, bicalutamide are allowed at PI discretion. * Initiation of ADT or SBRT or pelvic nodal radiation irradiation prior to trial enrollment (no time limit). * Live vaccine therapies for the prevention of infectious disease within 30 days prior to treatment administration. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted. * Contraindication to mpMRI including allergy or sensitivity to contrast agents (which cannot be alleviated by premedication) * Contraindications for SBRT such as: rectal wall invasion, history of inflammatory bowel disease, prior radiation in the treatment field that would exceed tissue tolerance. * Medical comorbidities that preclude the administration of androgen deprivation therapy or uncontrolled chronic or acute intercurrent illness /social situations or other illnesses considered by the Investigator as high risk for investigational drug treatment * Participants with active immune deficiencies, chronic inflammatory conditions, active autoimmune diseases, or participants on chronic immunosuppressive therapy for whom the primary endpoint of immune response could be impacted. * Participants requiring requiring systemic corticosteroids (\>10 mg daily prednisone equivalent) or immunosuppressive medications except inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or dose not threaten vital organ function including CN, heart, lungs, kidneys, skin and GI track will be allowed * Participants with HIV * Active Hepatitis B or Hepatitis C infection * Significant acute or chronic infections including tuberculosis (history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to M9241. * Participants with prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast or low risk Gleason 6 prostate cancer.

Inclusion Criteria

Exclusion Criteria

* Participants must have histologically or cytologically confirmed localized intermediate or high risk prostate cancer:
* Intermediate risk - Gleason 7 disease, PSA less than 10
* High Risk - Gleason 8-10, PSA\>10, Extracapsular Extension
* Participants must require treatment with SBRT to the prostate and ADT.
* Pre-treatment tissue availability (collected \<= 1 year to initiation of study therapy) for biomarker analysis is mandatory for enrollment. If tissue is determined to be of insufficient/unsuitable quality/quantity, a pre-treatment biopsy prior to initiation of study therapy will be required.
* Male age \>= 18 years old
* ECOG performance status \< 2
* Participants must have adequate organ and marrow function as defined below:
* absolute neutrophil count \>= 1,500/mcL, without CSF support
* platelets \>= 100,000/mcL
* AST(SGOT)/ALT(SGPT) \<= 2.5 X institutional upper limit of normal
* Hgb \>= 10g/dL (pRBC transfusions are not allowed to achieve acceptable Hgb)
* Total bilirubin \<= 1.5 x upper limit of normal (ULN),
* Serum albumin \>= 2.8 g/dL
* Creatine \<= 1.5 X institutional ULN
* Creatinine clearance \>= 50 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal by 24h urine
* PT/INR and aPTT \<= 1.5 X institutional ULN
* Testosterone greater than 100 ng/dL.
* Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for 6 months after completion of radiation treatment or immunotherapy (if taken, whatever is last)
* Participants must have prostate cancer accessible for biopsy
* Ability of participant to understand and the willingness to sign a written informed consent document.

* Evidence of distant metastatic disease (including clinically or pathologically positive lymph nodes or metastatic disease outside of the pelvis).
* Previous prostatectomy, focal therapy, or radiation to the prostate. Note: Previous finasteride, dutasteride, bicalutamide are allowed at PI discretion.
* Initiation of ADT or SBRT or pelvic nodal radiation irradiation prior to trial enrollment (no time limit).
* Live vaccine therapies for the prevention of infectious disease within 30 days prior to treatment administration. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.
* Contraindication to mpMRI including allergy or sensitivity to contrast agents (which cannot be alleviated by premedication)
* Contraindications for SBRT such as: rectal wall invasion, history of inflammatory bowel disease, prior radiation in the treatment field that would exceed tissue tolerance.
* Medical comorbidities that preclude the administration of androgen deprivation therapy or uncontrolled chronic or acute intercurrent illness /social situations or other illnesses considered by the Investigator as high risk for investigational drug treatment
* Participants with active immune deficiencies, chronic inflammatory conditions, active autoimmune diseases, or participants on chronic immunosuppressive therapy for whom the primary endpoint of immune response could be impacted.
* Participants requiring requiring systemic corticosteroids (\>10 mg daily prednisone equivalent) or immunosuppressive medications except inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or dose not threaten vital organ function including CN, heart, lungs, kidneys, skin and GI track will be allowed
* Participants with HIV
* Active Hepatitis B or Hepatitis C infection
* Significant acute or chronic infections including tuberculosis (history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings)
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to M9241.
* Participants with prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast or low risk Gleason 6 prostate cancer.

Contacts and Locations

Study Contact

Amy R Hankin, P.A.-C

CONTACT

(240) 858-3149

amy.hankin@nih.gov

Ravi A Madan, M.D.

CONTACT

(301) 480-7168

rm480i@nih.gov

Principal Investigator

Ravi A Madan, M.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Ravi A Madan, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-12

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2023-06-12

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

Immunotherapy + Radiation
Combination Therapy
Cancer Of Prostate
Nhs-Il 12

Additional Relevant MeSH Terms

Cancer Of Prostate