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Anti-mitotic Agent
ctDNA-Guided Therapy for Prostate Cancer (PROTRACT Trial)
Phase 2
Recruiting
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
Eligible for treatment with either enzalutamide or docetaxel as per standard of care guidelines
Evidence of biochemical or imaging progression in the setting of surgical or medical castration while on abiraterone. Progressive disease for study entry is defined by one of the following three criteria as per PCWG317:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
PROTRACT Trial Summary
This trial is testing whether using ctDNA to guide treatment decision-making leads to better outcomes than letting clinicians choose the treatment.
Who is the study for?
This trial is for adult males over 18 with metastatic castration-resistant prostate cancer who have previously been treated with abiraterone. Participants must show disease progression, consent to tissue analysis, and have adequate organ function. They cannot join if they've had seizures, brain metastases, certain gastrointestinal disorders, prior enzalutamide or docetaxel chemotherapy (with exceptions), other active cancers (with exceptions), or uncontrolled hypertension.Check my eligibility
What is being tested?
The study aims to optimize prostate cancer treatment by using circulating tumor DNA (ctDNA) levels to decide between two drugs: Enzalutamide for ctDNA fraction <2% and Docetaxel for ≥2%. This approach is compared against the clinician's choice of either drug without ctDNA guidance.See study design
What are the potential side effects?
Enzalutamide may cause fatigue, back pain, constipation, joint pain and hot flushes. Docetaxel can lead to effects like low blood cell counts increasing infection risk, hair loss, nausea/vomiting and muscle aches.
PROTRACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for treatment with enzalutamide or docetaxel.
Select...
My prostate cancer has worsened despite treatment with abiraterone.
Select...
My PSA levels have increased twice from the baseline in a week, with a minimum of 1.0 ng/mL at screening.
Select...
My cancer has grown by 20% or I have new cancer spots since starting treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My scans show cancer has spread to my bones or other parts.
Select...
I have been treated with abiraterone for prostate cancer.
Select...
I have recovered from previous cancer treatment side effects.
Select...
My kidneys work well enough (creatinine clearance ≥ 30 ml/min).
Select...
I have prostate cancer without certain rare features, and my PSA was over 20 when diagnosed.
Select...
I am a man aged 18 or older.
PROTRACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Clinical benefit rate (CBR)
Correlation of specific ctDNA-based genomic alterations to treatment response
Objective response
+3 morePROTRACT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: A: Biomarker directed Therapy (BT)Experimental Treatment2 Interventions
ctDNA fraction <2% receives enzalutamide, and ctDNA fraction ≥2% receives docetaxel until disease progression, then cross-over to the other therapy (e.g., enzalutamide to docetaxel, or docetaxel to enzalutamide).
Group II: B: Clinician's Choice (CC)Active Control2 Interventions
Enzalutamide or docetaxel until disease progression, then cross-over to the other therapy (e.g., enzalutamide to docetaxel, or docetaxel to enzalutamide).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Enzalutamide
2014
Completed Phase 4
~2760
Find a Location
Who is running the clinical trial?
British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,411 Total Patients Enrolled
24 Trials studying Prostate Cancer
5,812 Patients Enrolled for Prostate Cancer
Daniel Khalaf, MDStudy ChairBritish Columbia Cancer Agency
Kim N Chi, MDStudy ChairBritish Columbia Cancer Agency
5 Previous Clinical Trials
475 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is not higher than 160/100 mmHg.My bone scans show at least 2 new lesions, confirmed 8 weeks apart.I am eligible for treatment with enzalutamide or docetaxel.My prostate cancer has worsened despite treatment with abiraterone.I have had chemotherapy with docetaxel or cabazitaxel, except if it was for early-stage disease and I didn't worsen for 12 months after.I have a digestive condition that affects how my body absorbs nutrients.My organs are functioning well.I have brain metastases or active epidural disease.My PSA levels have increased twice from the baseline in a week, with a minimum of 1.0 ng/mL at screening.My cancer has grown by 20% or I have new cancer spots since starting treatment.I can take pills and follow the study's requirements, including giving blood samples.I have not had a seizure or stroke in the last 6 months.I can take care of myself and am up and about more than half of my waking hours.My scans show cancer has spread to my bones or other parts.I have been treated with abiraterone for prostate cancer.I have recovered from previous cancer treatment side effects.I haven't had certain types of radiation therapy in the last 28 days.I have previously been treated with enzalutamide or similar drugs.My kidneys work well enough (creatinine clearance ≥ 30 ml/min).I have prostate cancer without certain rare features, and my PSA was over 20 when diagnosed.I am a man aged 18 or older.I do not have any active cancer except for non-dangerous skin cancer or any cancer that has been cured and without signs for over 3 years.I cannot take prednisone due to my uncontrolled diabetes.I have not had major surgery in the last 4 weeks.I have had surgery or am on hormone therapy to lower my testosterone for prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: A: Biomarker directed Therapy (BT)
- Group 2: B: Clinician's Choice (CC)
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.
How many healthcare centers are participating in this trial?
"Four medical centres are currently accepting participants to this clinical trial, such as BC Cancer - Surrey Centre in Surrey, BC Cancer - Vancouver Centre in Vancouver, and the BC Cancer - Victoria Centre found in Victoria."
Answered by AI
What is the participant enrollment for this particular investigation?
"Affirmative. As noted on clinicaltrials.gov, the medical trial from October 7th 2020 is still actively recruiting patients. 100 participants are needed to be recruited from 4 sites around the country."
Answered by AI
Has Docetaxel received official sanction from the FDA?
"Docetaxel's safety has been partially established, resulting in it receiving a score of 2. Unfortunately, efficacy data is still lacking for this Phase 2 trial."
Answered by AI
What other investigations have been completed concerning Docetaxel?
"Presently, 403 clinical studies are underway to evaluate Docetaxel's efficacy. Out of these trials, 150 are in the advanced Phase 3 stage. Although most research is conducted at a single site in Germantown, Tennessee, this treatment has been subject to study across 27508 different medical facilities."
Answered by AI
Are there still vacancies available for participants within this experiment?
"Affirmative. Clinicaltrials.gov displays that this scientific endeavor, which was first made available on October 7th 2020, is presently recruiting individuals for the study. Requiring 100 participants at 4 different medical centres."
Answered by AI
What maladies does Docetaxel typically alleviate?
"Docetaxel is predominantly used to treat cancerous tumours. There are, however, exceptions where it can be prescribed for a range of different malignancies including advanced directives, sarcoma and esophageal neoplasms."
Answered by AI
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