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Radiation Therapy

Radiotherapy for Prostate Cancer (PROMPT Trial)

N/A
Recruiting
Led By Juanita Crook, MD
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed adenocarcinoma of the prostate
No prior therapy for prostate cancer apart from androgen deprivation
Must not have
Abnormal liver function
Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare ultrahypofractionation using SABR or brachytherapy to moderately hypofractionated EBRT to see if it is as well tolerated. They will also look at progression-free survival, overall survival, and cost-effectiveness.

Who is the study for?
Men with newly diagnosed prostate cancer that has spread only a little (oligometastatic) can join. They should be planning long-term hormone therapy, in good health for treatment and follow-up, and have not had other prostate cancer treatments except hormone drugs started within the last 24 weeks.
What is being tested?
The trial is testing if using focused radiation (SABR or brachytherapy) is as safe and well-tolerated as standard external beam radiotherapy for treating oligometastatic prostate cancer. It also looks at survival rates and cost-effectiveness compared to the standard approach.
What are the potential side effects?
Possible side effects include irritation of bladder or bowel, fatigue, sexual dysfunction, urinary issues like difficulty or increased frequency, skin reactions in treated area, and potential risks associated with anesthesia during procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer diagnosis was confirmed through a tissue examination.
Select...
I have only received hormone therapy for my prostate cancer.
Select...
I am scheduled for long-term hormone therapy to lower testosterone levels.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer is newly diagnosed and has a few spread sites.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My liver isn't working properly.
Select...
I cannot have external beam radiation due to conditions like inflammatory bowel disease or previous pelvic radiation.
Select...
My prostate is larger than 60cc after treatment to reduce its size.
Select...
I am considered medically unfit for anesthesia.
Select...
I have 5 or more bone or organ metastases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Urinary symptoms
Secondary study objectives
Biochemical failure (time to increase in prostate specific antigen (ng/ml) to 50% > nadir
Cause specific survival
Cost effectiveness
+6 more

Side effects data

From 2018 Phase 4 trial • 19 Patients • NCT01344356
100%
Mucositis
100%
Fatigue
100%
Dizziness
100%
Cranial Nerve Neuropathy
100%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benign Tumors
Malignant Tumors

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic body radiotherapyExperimental Treatment1 Intervention
36.25 Gy is delivered to the prostate in 5 fractions given either weekly or every second day, using a SABR technique.
Group II: Permanent seed implant brachytherapyExperimental Treatment1 Intervention
A single permanent implant of radioactive Iodine-125 seeds is performed under anesthesia as an out patient to deliver 125 Gy to the prostate
Group III: High dose rate brachytherapyExperimental Treatment1 Intervention
A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient.
Group IV: standardActive Control1 Intervention
External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic body radiotherapy
2021
Completed Phase 4
~840

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor
176 Previous Clinical Trials
95,060 Total Patients Enrolled
22 Trials studying Prostate Cancer
4,208 Patients Enrolled for Prostate Cancer
Juanita Crook, MDPrincipal InvestigatorBCCancer
4 Previous Clinical Trials
785 Total Patients Enrolled
1 Trials studying Prostate Cancer
190 Patients Enrolled for Prostate Cancer

Media Library

High dose rate brachytherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04610372 — N/A
Prostate Cancer Research Study Groups: standard, High dose rate brachytherapy, Permanent seed implant brachytherapy, Stereotactic body radiotherapy
Prostate Cancer Clinical Trial 2023: High dose rate brachytherapy Highlights & Side Effects. Trial Name: NCT04610372 — N/A
High dose rate brachytherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04610372 — N/A
~0 spots leftby Jan 2025
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