ARM 1 - 2 weeks for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Weill Cornell Medicine, New York, NYProstate Cancer5 days Radiation Therapy (32.5 Gy in 5 fractions) - Radiation
Eligibility
18 - 90
Male
What conditions do you have?
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Study Summary

This trial will compare two types of radiation therapy for men with prostate cancer that has come back after surgery. One type is given over 4 weeks and the other over 2 weeks. The study will look at side effects and health scores.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Hypofractionated Radiation Therapy
1
Treatment (MRI-guided IMRT, ADT)
1
High-Dose Rate Brachytherapy

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Through study completion, an average of 10 years

Month 60
Change in the number of patient reported GI-GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
Overall survival (OS)
Time to progression (TTP)
Month 24
Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
Year 10
Number of patients who expired due to prostate cancer.

Trial Safety

Safety Progress

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

Similar Trials

1
Hypofractionated Radiation Therapy
2
Treatment (MRI-guided IMRT, ADT)
1
High-Dose Rate Brachytherapy

Trial Design

2 Treatment Groups

ARM 1 - 2 weeks
1 of 2
ARM 2 - 4 weeks
1 of 2

Active Control

134 Total Participants · 2 Treatment Groups

Primary Treatment: ARM 1 - 2 weeks · No Placebo Group · Phase 2

ARM 1 - 2 weeks
Radiation
ActiveComparator Group · 1 Intervention: 5 days Radiation Therapy (32.5 Gy in 5 fractions) · Intervention Types: Radiation
ARM 2 - 4 weeks
Radiation
ActiveComparator Group · 1 Intervention: 20 days Radiation therapy (55 Gy in 20 fractions) · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 10 years

Who is running the clinical trial?

Viewray Inc.Industry Sponsor
11 Previous Clinical Trials
970 Total Patients Enrolled
1 Trials studying Prostate Cancer
136 Patients Enrolled for Prostate Cancer
Weill Medical College of Cornell UniversityLead Sponsor
997 Previous Clinical Trials
1,331,731 Total Patients Enrolled
46 Trials studying Prostate Cancer
49,055 Patients Enrolled for Prostate Cancer
Himanshu Nagar, M.D.Principal InvestigatorWeill Medical College of Cornell University
5 Previous Clinical Trials
207 Total Patients Enrolled
2 Trials studying Prostate Cancer
171 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18 - 90 · Male Participants · 6 Total Inclusion Criteria

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You can answer questions in the EPIC questionnaire.
References

Frequently Asked Questions

How do I sign up for the clinical trial?

"Prostate cancer patients that are between 18 and 90 years old may be eligible for this study. The research team is currently trying to enroll 134 people in total." - Anonymous Online Contributor

Unverified Answer

How many people can enroll in this clinical trial?

"That is accurate. The listing for this clinical trial on clinicaltrials.gov says that it is still looking for patients to enroll. This particular study was posted on September 24th, 2020 and updated as recently as June 29th, 2022. They are hoping to have 134 people participate at a single location." - Anonymous Online Contributor

Unverified Answer

Are young adults eligible to participate in this experiment?

"As long as potential patients are above the age of 18 and have not yet reached their 90th birthday, they will be eligible for this trial." - Anonymous Online Contributor

Unverified Answer

Is there a high risk of developing complications from ARM 1 - 2 weeks after treatment?

"While there is some safety data from Phase 2 trials, there is none currently supporting efficacy. Therefore, our team has rated the ARM 1-2 weeks as a 2." - Anonymous Online Contributor

Unverified Answer

Are we still enrolling people in this experiment?

"Yes, the information on clinicaltrials.gov indicates that this clinical trial is actively recruiting patients. The clinical trial was originally posted on 9/24/2020 and was most recently updated on 6/29/2022. The clinical trial is enrolling 134 participants across 1 locations" - 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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