Study Summary
This trial is testing a treatment for prostate cancer that has come back after prior radiotherapy, which involves the placement of a radioactive material in the affected area of the prostate temporarily, and then is subsequently removed using a minimally invasive technique. Participants will also receive external radiation for 5 weeks targeting the pelvis and giving a higher dose each day to the suspicious lymph nodes on PET scan.
Eligible Conditions
- Prostate Cancer Recurrence
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 24 months
24 months
Toxicity rate
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
HDR Brachytherapy + EBRT + STAD
1 of 1
Experimental Treatment
24 Total Participants · 1 Treatment Group
Primary Treatment: HDR Brachytherapy + EBRT + STAD · No Placebo Group · Phase 1 & 2
HDR Brachytherapy + EBRT + STAD
Radiation
Experimental Group · 1 Intervention: HDR Brachytherapy + EBRT + STAD · Intervention Types: RadiationTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
Who is running the clinical trial?
Loyola UniversityLead Sponsor
150 Previous Clinical Trials
30,560 Total Patients Enrolled
Abhishek Solanki, MDPrincipal InvestigatorLoyola University Chicago
1 Previous Clinical Trials
50 Total Patients Enrolled
Eligibility Criteria
Age 18 - 99 · Male Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You can participate if you need to undergo radiation therapy for cancer treatment using specific methods like external beam therapy, brachytherapy, or stereotactic body radiotherapy. Additionally, you have specific cancer-related characteristics in your pelvic region and are also eligible for hormonal therapy.
References
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- Abhishek A. Solanki 2018. "BEACON: HDR Brachytherapy, EBRT and STAD for the Treatment of Local and Pelvic Recurrence of Prostate Cancer After Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03553602.
Frequently Asked Questions
Is there still an opportunity to participate in this research endeavor?
"According to the clinicaltrials.gov website, this research endeavour is currently recruiting participants and was initially made public on May 29th 2018 with a recent update transpired in 2020 of that same month." - Anonymous Online Contributor
Unverified Answer
Is the age criteria for this medical trial limited to those over 85 years old?
"This trial is open to participants between 18 and 99 years old. For those under the age of 18, there are 231 different clinical trials available, while 2110 exams can be found for individuals over 65." - Anonymous Online Contributor
Unverified Answer
How many subjects are being monitored for the current clinical investigation?
"Affirmative. The clinical trial registry on clinicaltrials.gov confirms that this experiment, which was first listed in May 2018, is actively recruiting participants. 24 people need to be recruited from one medical centre for the completion of this research project." - Anonymous Online Contributor
Unverified Answer
Who is the ideal candidate for participation in this research project?
"This clinical trial is seeking 24 individuals with [recurrent prostate cancer](https://www.withpower.com/clinical-trials/recurrent-prostate-cancer) aged between 18 and 99. Eligibility criteria include: biopsy-proven adenocarcinoma of the prostate, Mx or M0 stages cT1 to T3a, Nx or N0 status, external beam radiotherapy using photons/protons, definitive brachytherapy, stereotactic body radiotherapy (SBRT), F18-fluciclovine positive pelvic nodes without distal metastasis nor lymph node involvement beyond this area; also a candidate for hormonal therapy plus an ECOG performance score ranging from 0 to 2 on the" - Anonymous Online Contributor
Unverified Answer