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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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Rates of acute toxicity
Secondary study objectives
Measure failure-free survival
Rates of late toxicity.

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
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%
Dysphagia-esophageal radiation
8%
Hypoglycemia
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)

Awards & Highlights

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

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
1,521 Previous Clinical Trials
503,264 Total Patients Enrolled

Media Library

Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05656794 — Phase 2
Prostate Metastasis Research Study Groups: Arm 1 - Investigational, Arm 2 - Standard
Prostate Metastasis Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT05656794 — Phase 2
Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05656794 — Phase 2
~27 spots leftby Aug 2031
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