Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate CancerStereotactic Body Radiation Therapy (SBRT) - Radiation
Eligibility
18+
Male
What conditions do you have?
Select

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.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: four weeks after start of treatment

Week 4
Evaluate peripheral immune response
evaluate T-cell clonality as measures of immunologic activity
four weeks after start of treatment
To determine safety and tolerated doses of M9241 and SBRT

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Gem + Xeloda + SBRT
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)
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01360593) in the Gem + Xeloda + SBRT ARM group. Side effects include: Anemia with 21%, Neutropenia with 18%, Hypoalbuminemia with 15%, White blood cell decreased ( leukopenia) with 15%, Diarrhea with 15%.

Trial Design

3 Treatment Groups

2/Arm 2a
1 of 3
3/Arm 2b
1 of 3
1/Arm 1
1 of 3

Experimental Treatment

65 Total Participants · 3 Treatment Groups

Primary Treatment: Stereotactic Body Radiation Therapy (SBRT) · No Placebo Group · Phase 2

2/Arm 2aExperimental Group · 2 Interventions: M9241, Stereotactic Body Radiation Therapy (SBRT) · Intervention Types: Drug, Radiation
3/Arm 2b
Radiation
Experimental Group · 1 Intervention: Stereotactic Body Radiation Therapy (SBRT) · Intervention Types: Radiation
1/Arm 1Experimental Group · 2 Interventions: M9241, Stereotactic Body Radiation Therapy (SBRT) · Intervention Types: Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2014
Completed Phase 2
~660

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: four weeks after start of treatment

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,077 Previous Clinical Trials
41,139,563 Total Patients Enrolled
536 Trials studying Prostate Cancer
502,331 Patients Enrolled for Prostate Cancer
Ravi A Madan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
16 Previous Clinical Trials
923 Total Patients Enrolled
10 Trials studying Prostate Cancer
761 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a Gleason score of 8-10, a PSA level of 10, and extracapsular extension.
You have intermediate risk disease, PSA less than 10.
Participants must be treated with SBRT to the prostate and ADT.