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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
PROMPT Trial 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.Check my eligibility
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.See study design
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.
PROMPT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer diagnosis was confirmed through a tissue examination.
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I have only received hormone therapy for my prostate cancer.
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I am scheduled for long-term hormone therapy to lower testosterone levels.
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer is newly diagnosed and has a few spread sites.
PROMPT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary symptoms
Secondary outcome measures
Biochemical failure (time to increase in prostate specific antigen (ng/ml) to 50% > nadir
Cause specific survival
Cost effectiveness
+6 moreSide effects data
From 2018 Phase 4 trial • 19 Patients • NCT01344356100%
Dizziness
100%
Cranial Nerve Neuropathy
100%
Fatigue
100%
Alopecia
100%
Mucositis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benign Tumors
Malignant Tumors
PROMPT 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
2014
Completed Phase 4
~370
Find a Location
Who is running the clinical trial?
British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,343 Total Patients Enrolled
24 Trials studying Prostate Cancer
5,812 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a prostate surgery (TURP) within the last 12 weeks before brachytherapy.My prostate cancer diagnosis was confirmed through a tissue examination.I have only received hormone therapy for my prostate cancer.I started hormone therapy for my cancer within the last 24 weeks.I can undergo all required tests before and within 12 weeks of starting ADT or being assigned to a treatment group.My liver isn't working properly.I cannot have external beam radiation due to conditions like inflammatory bowel disease or previous pelvic radiation.I am scheduled for long-term hormone therapy to lower testosterone levels.My prostate is larger than 60cc after treatment to reduce its size.I can take care of myself and am up and about more than half of my waking hours.I am considered medically unfit for anesthesia.The shape and size of your pelvic area could make it difficult to safely insert medical equipment during the study.You have severe urinary problems with an International Prostate Symptom Score (IPSS) greater than 20.My cancer is newly diagnosed and has a few spread sites.I have 5 or more bone or organ metastases.I started anti-androgen therapy less than 26 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: standard
- Group 2: High dose rate brachytherapy
- Group 3: Permanent seed implant brachytherapy
- Group 4: Stereotactic body radiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings remaining in this clinical exploration?
"As per clinicaltrials.gov, this experiment is currently seeking volunteers - it was first made available on December 7th 2021 and the latest update came on March 3rd 2022."
Answered by AI
At what venues is this clinical experiment taking place?
"Four medical sites are participating in the clinical trial, including Vancouver Island Cancer Center located in Victoria, Vancouver Cancer Centre based in Vancouver and Fraser Valley Cancer Centre situated in Surrey. Additionally, there exist 4 additional locations taking part as well."
Answered by AI
How many patients are currently being administered this clinical trial?
"Affirmative. The clinical trial was initially published on July 12th 2021, and is currently listed as actively recruiting patients according to information found on clinicaltrials.gov. 168 volunteers from 4 different medical centres need to be enlisted for the study's completion."
Answered by AI
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