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Hormone Therapy

Hormone Therapy + SBRT for Prostate Cancer

Phase 1 & 2
Recruiting
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approx 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My cancer has spread to no more than 3 areas, as shown by a PSMA scan.
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I am fully active or can carry out light work.
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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.
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My prostate cancer has returned, with a rising PSA level, but no new growth in the prostate.
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All my cancer areas can be safely treated with targeted radiation.
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I am older than 18 years.
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I have been diagnosed with prostate cancer.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of eligible patients who enroll onto the study
Secondary outcome measures
Side Effects and Effectiveness

Side effects data

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

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
654 Previous Clinical Trials
1,543,267 Total Patients Enrolled
33 Trials studying Prostate Cancer
12,232 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

Frequently Asked Questions

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

Are there any opportunities to become involved in this research endeavor?

"Per the information listed on clinicaltrials.gov, this research is actively enrolling participants and was initially published online on October 27th 2020 with its most recent update occurring December 1st of the same year."

Answered by AI

How many individuals are being monitored for this research endeavor?

"Affirmative. Clinicaltrials.gov data suggests that this research is actively recruiting participants, with 30 enrollees needed from one medical facility since the trial's initial posting on October 27th 2020 and its last update in December 1st 2020."

Answered by AI
~7 spots leftby Mar 2025