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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
Must not have
Patients who present with de novo stage IV disease with pelvic lymphadenopathy as their only site of metastases (N1 M0), where the primary prostate has never been treated with curative intent prostate surgery or radiotherapy in the past
Castration resistant prostate cancer, defined as rising PSA (per PCWG3) or radiographic progression in the setting of castrate levels of serum testosterone (< 1.7 nmol/L)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights

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.
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.
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.

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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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 am 18 years old or older.
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I have 3 or fewer cancer spots in organs other than bones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My prostate cancer has spread to pelvic lymph nodes only and hasn't been treated before.
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My prostate cancer is growing despite low testosterone levels.
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My cancer cannot be treated by targeting just the affected areas.
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My cancer has spread to the brain.
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I have had treatment for my cancer that has returned or spread.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adrenal gland hypofunction
Secondary study objectives
Economic analysis measured by EQ-5D-5L
Incidence of new metastases as first event
Overall Survival
+4 more

Side effects data

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

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
932 Total Patients Enrolled
1 Trials studying Prostate Cancer
500 Patients Enrolled for Prostate Cancer
Canadian Cancer Trials GroupLead Sponsor
127 Previous Clinical Trials
67,864 Total Patients Enrolled
11 Trials studying Prostate Cancer
7,135 Patients Enrolled for Prostate Cancer
Canadian Cancer Society (CCS)OTHER
79 Previous Clinical Trials
37,278 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
~130 spots leftby Dec 2026
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