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Stereotactic Body Radiation Therapy for Prostate Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, CAProstate Adenocarcinoma+5 MoreStereotactic Body Radiation Therapy - Radiation
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial is testing a way to predict which prostate cancer patients will experience long-term genitourinary toxicity after radiation therapy, so that patients and doctors can make more informed decisions about treatment.

Eligible Conditions
  • Prostate Adenocarcinoma
  • Stage I Prostate Cancer
  • Stage II Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Up to 5 years

Year 5
Change in patient-reported bowel quality of life
Change in patient-reported sexual quality of life by the Sexual Health Inventory for Men instrument by five years
Change in patient-reported sexual quality of life outcome
Change in patient-reported urinary quality of life
Up to 5 years
5-year biochemical recurrence-free survival
5-year cumulative incidence of Late grade >= 2 GU physician-scored toxicity
5-year cumulative incidence of late grade >= 2 physician-scored genitourinary toxicity
Proportions of patients who choose to receive radiation treatment
Day 90
Rate of acute grade >= 2 genitourinary and gastrointestinal physician-scored toxicity
Day 90
Rate of acute grade >= 2 gastrointestinal physician-scored toxicity

Trial Safety

Safety Progress

1 of 3

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Side Effects for

Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
55%Leukopenia
36%Thrombocytopenia
36%Lymphopenia
18%AST elevation
18%ALT elevation
18%Anemia
18%Reduced ANC
9%Sinusitis
9%Pneumonia
9%Pancreatitis
9%Hyperkalemia
9%Urinary tract infection
9%Sepsis
9%Pleural effusion
9%Acidosis
9%Cardiac disorders
9%Orthostasis
9%Rash
9%Nausea
9%Vomiting
9%Dehydration
9%Depression
9%Somnolence
9%Hypokalemia
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01959672) in the Treatment (Chemotherapy, Oregovomab, SBRT, Surgery) ARM group. Side effects include: Leukopenia with 55%, Thrombocytopenia with 36%, Lymphopenia with 36%, AST elevation with 18%, ALT elevation with 18%.

Trial Design

1 Treatment Group

Treatment (radiotherapy, genomic DNA testing)
1 of 1

Experimental Treatment

198 Total Participants · 1 Treatment Group

Primary Treatment: Stereotactic Body Radiation Therapy · No Placebo Group · N/A

Treatment (radiotherapy, genomic DNA testing)Experimental Group · 6 Interventions: Laboratory Biomarker Analysis, Discussion, Hypofractionated Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Body Radiation Therapy · Intervention Types: Other, Procedure, Radiation, Other, Other, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Discussion
2018
N/A
~100
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~650

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
21,546 Total Patients Enrolled
MiraDXUNKNOWN
Amar KishanPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
4 Previous Clinical Trials
529 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

How many participants are in the clinical trial at its peak capacity?

"Affirmative. Clinical trial records hosted on clinicaltrials.gov confirm that this medical research, which was first published on November 10th 2020, is still open for applicants. The study aims to enlist 200 participants from a single centre." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies available for participation in this experiment?

"According to the clinicaltrials.gov, this medical trial is currently recruiting participants with initiation of recruitment beginning in November 2020 and most recent update taking place on December 1st 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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