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Local Ablative Therapy for Prostate Cancer (PLATON Trial)

N/A
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic diagnosis/confirmation of prostate adenocarcinoma and no evidence of small cell cancer
Stage IV at presentation or relapse after curative intent therapy, classification per AJCC 8th edition: M1 disease with ≤ 5 metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights

PLATON Trial Summary

This trial will compare the effectiveness of different treatments for prostate cancer.

Who is the study for?
Men over 18 with hormone-sensitive prostate cancer that has spread to no more than five places and hasn't become resistant to hormonal therapy. They should be in good physical condition, able to fill out questionnaires in English or French, and willing to use effective contraception. Those who've had certain previous treatments or have brain metastases can't join.Check my eligibility
What is being tested?
The trial is testing whether adding ablative therapy (targeted radiation or surgery) to standard care improves outcomes for men with limited-spread prostate cancer compared to standard care alone. Participants will be randomly assigned to one of the two approaches.See study design
What are the potential side effects?
Ablative therapy might cause pain, swelling at the treatment site, fatigue, urinary issues, bowel changes, and skin reactions. Standard treatments also have side effects like hot flashes, sexual dysfunction, bone thinning and mood swings.

PLATON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is adenocarcinoma without any small cell cancer.
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My cancer is stage IV with 5 or fewer metastases.
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My cancer has spread to 3 or fewer places in my body, not including bones.
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My prostate cancer is adenocarcinoma without any small cell cancer.
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My prostate cancer and any spread can be treated with surgery or radiation.
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I am fully active or can carry out light work.
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I am a man who can father children and agree to use effective birth control during the study.
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I am fully active or can carry out light work.
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My prostate cancer and any spread can be treated with surgery or radiation.
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I can and will complete questionnaires in English or French.
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I started or will start Zoladex within 12 weeks around my trial entry.
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I can attend all treatments and follow-ups for the study.
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I am 18 years old or older.
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I am medically cleared by doctors for the study treatments.
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My treatment for cancer spread starts within 6 weeks after being chosen for the trial.
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My cancer is stage IV with 5 or fewer spread sites.
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I agree to provide a sample of my tumor for study, and my doctor can get it.
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I have another cancer, but it won't affect this treatment's safety or results.
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I am 18 years old or older.
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I have 3 or fewer cancer spots in organs other than bones.

PLATON Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adrenal gland hypofunction
Secondary outcome measures
Ablative treatment related adverse events (>/= grade 3) using CTCAE v5.0
Economic analysis by determining an incremental cost-effectiveness ratio reported as a difference in cost per FFS-year between the 2 arms
Economic analysis measured by EQ-5D-5L
+6 more

Side effects data

From 2007 Phase 4 trial • 552 Patients • NCT00110890
7%
Vomiting
7%
Diarrhoea
3%
Nasopharyngitis
3%
Nausea
3%
Muscle spasms
1%
Arteriovenous fistula occlusion
1%
Orthostatic hypotension
1%
Angina pectoris
1%
Cardiac arrest
1%
Myocardial infarction
1%
Pericarditis
1%
Chest discomfort
1%
Chest pain
1%
Hernia
1%
Pyrexia
1%
Cholecystitis
1%
Jaundice
1%
Arthritis bacterial
1%
Bacterial sepsis
1%
Arteriovenous fistula thrombosis
1%
Fall
1%
Shunt thrombosis
1%
Hypovolaemia
1%
Back pain
1%
Pain in extremity
1%
Dyspnoea
1%
Skin ulcer
1%
Catheter placement
1%
Nephrectomy
1%
Hypertensive crisis
1%
Hypotension
1%
Peripheral ischaemia
1%
Atrial flutter
1%
Cardiac asthma
1%
Abdominal pain
1%
Sudden cardiac death
1%
Transplant rejection
1%
Gastroenteritis
1%
Perianal abscess
1%
Pneumonia
1%
Urinary tract infection
1%
Ankle fracture
1%
Arteriovenous fistula site complication
1%
Joint dislocation
1%
Joint injury
1%
Rib fracture
1%
Shunt occlusion
1%
Blood potassium increased
1%
Fluid retention
1%
Pancreatic carcinoma
1%
Cerebral infarction
1%
Cognitive disorder
1%
Gastrointestinal haemorrhage
1%
Catheter related infection
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Care
Cinacalcet

PLATON Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 (standard systemic therapy + ablative therapy))Experimental Treatment2 Interventions
Local Ablative therapy to all sites of disease (including untreated prostate primary) + Standard systemic therapy
Group II: Arm 1 (standard of care)Active Control1 Intervention
Standard systemic therapy + Ablative therapy to untreated prostate primary for patients with low volume metastatic disease burden
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ablative Radiation Therapy
2018
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

TerSera Therapeutics LLCIndustry Sponsor
9 Previous Clinical Trials
1,039 Total Patients Enrolled
1 Trials studying Prostate Cancer
500 Patients Enrolled for Prostate Cancer
Canadian Cancer Trials GroupLead Sponsor
122 Previous Clinical Trials
66,742 Total Patients Enrolled
11 Trials studying Prostate Cancer
7,135 Patients Enrolled for Prostate Cancer
Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,335 Total Patients Enrolled
8 Trials studying Prostate Cancer
7,625 Patients Enrolled for Prostate Cancer

Media Library

Standard of care (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03784755 — N/A
Prostate Cancer Research Study Groups: Arm 2 (standard systemic therapy + ablative therapy)), Arm 1 (standard of care)
Prostate Cancer Clinical Trial 2023: Standard of care Highlights & Side Effects. Trial Name: NCT03784755 — N/A
Standard of care (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03784755 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide a list of the healthcare facilities that are currently running this clinical trial within state boundaries?

"This research trial involves the participation of 15 clinical sites, such as Algoma District Cancer Program in Sault Ste. Marie, Ottawa Hospital Research Institute in Ottawa and Health Sciences North in Sudbury; all other locations are listed online."

Answered by AI

What is the current sample size of this investigation?

"TerSera Therapeutics LLC, the body overseeing the trial, requires 410 participants that match their criteria to run it. Two of these sites are Algoma District Cancer Program in Sault Ste. Marie, Ontario and Ottawa Hospital Research Institute in Ottawa, Quebec."

Answered by AI

Does this scientific research presently seek participants?

"Affirmative. According to information on clinicaltrials.gov, the medical trial opened for recruitment on April 18th 2019 and is currently accepting participants. The study aims to admit 410 patients from 15 distinct locations."

Answered by AI
~159 spots leftby Dec 2026