Your session is about to expire
← Back to Search
Radiation Therapy
Short vs Long Course Radiotherapy for Prostate Cancer (CONSORT-PC Trial)
Phase 2
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
CONSORT-PC Trial Summary
This trial looks at whether two weeks of radiation has the same effects as 6 weeks of radiation.
Who is the study for?
Men aged 18+ with metastatic prostate cancer, either low or high volume, are eligible. They must be fit for daily activities (ECOG 0 or 1), planning to receive external beam radiation therapy (EBRT) while on hormone therapy +/- ARAT. Prior chemotherapy is okay if it was over six weeks ago. Men with active inflammatory bowel disease or conditions that rule out radiotherapy, especially prior pelvic radiation, can't join.Check my eligibility
What is being tested?
This study compares two schedules of delivering radiation treatment for metastatic prostate cancer: one group will receive treatments every other day for two weeks and the other once weekly for six weeks. The goal is to see if side effects differ between these schedules.See study design
What are the potential side effects?
Radiation may cause fatigue, skin reactions in treated areas, frequent urination with possible discomfort, bowel changes like diarrhea or pain during movements, and a risk of erectile dysfunction.
CONSORT-PC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rates of acute toxicity
Secondary outcome measures
Measure failure-free survival
Rates of late toxicity.
Side effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
CONSORT-PC Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2 - StandardExperimental Treatment1 Intervention
Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.
Group II: Arm 1 - InvestigationalExperimental Treatment1 Intervention
Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a health condition that prevents me from receiving radiotherapy.I am scheduled for external beam radiation therapy.I have had radiation therapy to my pelvic area before.My cancer has spread to other parts of my body, including possibly my bones or organs.I am 18 years old or older.My prostate cancer has spread and was confirmed by a biopsy.I am on hormone therapy for my cancer, with or without additional targeted therapy.I am fully active or restricted in physically strenuous activity but can do light work.My doctor confirms I have active ulcerative colitis or Crohn's Disease.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 - Investigational
- Group 2: Arm 2 - Standard
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.
Is the investigational drug in Arm 1 of this trial approved by the FDA?
"Arm 1 - Investigational was judged as 2 on the safety scale, due to Phase 2 trial data suggesting that it is safe but without any evidence for efficacy."
Answered by AI
Do I fulfill the criteria for participation in this trial?
"The qualifications to join this research trial are a diagnosis of metastatic prostate cancer and an age between 18 and 100. Forty individuals will be enrolled in total."
Answered by AI
Are there age restrictions for the participants in this trial?
"The age qualifications for this clinical trial are 18 to 100. Those younger than 18 can look into 73 other studies, whilst those older than 65 have 1255 options available."
Answered by AI
Are there still opportunities for participants to join this trial?
"According to the clinicaltrials.gov website, this particular study has concluded its recruitment process; it was first posted on March 1st 2023 and last updated on December 9th 2022. Nonetheless, there are still a multitude of other trials actively seeking participants at present- 1260 in total."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger