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Hormone Therapy

Hormone Therapy + SBRT for Prostate Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Up to a maximum of 3 PSMA avid areas of metastatic disease.
ECOG performance status 0-1.
Must not have
History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
Significant comorbidities rendering patient not suitable for ADT and/or SBRT.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approx 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new, more focused type of radiotherapy to see if it improves outcomes for patients with cancer who are negative on conventional imaging but positive on PSMA PET scan.

Who is the study for?
Men over 18 with hormone-sensitive, oligometastatic prostate cancer visible on PSMA PET-CT but not on conventional imaging. They must have a good performance status (able to carry out daily activities), up to 3 areas of metastasis treatable by SBRT, and controlled primary tumor without progression. Excluded are those with castrate-resistant cancer, spinal cord compression, recent ADT for palliation or other cancers in the past 5 years.
What is being tested?
The trial is testing if adding stereotactic body radiotherapy (SBRT) to hormone therapy improves outcomes in patients with specific types of advanced prostate cancer that's still responsive to hormones and has limited spread as seen on specialized scans.
What are the potential side effects?
Potential side effects include typical reactions from radiation like skin irritation, fatigue, urinary issues, and bowel problems; plus hormonal treatment side effects such as hot flashes, sexual dysfunction, bone thinning and mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has spread to no more than 3 areas, as shown by a PSMA scan.
Select...
I am fully active or can carry out light work.
Select...
My prostate cancer is in stage IV, sensitive to hormones, and has a few spread sites not seen on regular scans but visible on a PSMA PET-CT.
Select...
All my cancer areas can be safely treated with targeted radiation.
Select...
I am older than 18 years.
Select...
I have been diagnosed with prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had cancer, except for non-melanoma skin or in-situ cancer, in the last 5 years.
Select...
I have health issues that make hormone therapy or radiation unsuitable for me.
Select...
My prostate cancer is not responding to hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approx 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approx 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
Proportion of eligible patients who enroll onto the study
Secondary study objectives
Side Effects and Effectiveness

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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
Active Control
Group I: Arm 2: SBRT to metsExperimental Treatment2 Interventions
Intermittent Hormone treatment (minimum of 8 months) + SBRT to all sites of metastatic disease
Group II: Arm 1: Standard of CareActive Control1 Intervention
Intermittent Hormone treatment (minimum of 8 months)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2014
Completed Phase 2
~1060

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,855 Total Patients Enrolled
31 Trials studying Prostate Cancer
12,051 Patients Enrolled for Prostate Cancer

Media Library

Hormone therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04619069 — Phase 1 & 2
Prostate Cancer Research Study Groups: Arm 2: SBRT to mets, Arm 1: Standard of Care
Prostate Cancer Clinical Trial 2023: Hormone therapy Highlights & Side Effects. Trial Name: NCT04619069 — Phase 1 & 2
Hormone therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04619069 — Phase 1 & 2
~5 spots leftby Oct 2025
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