Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer

Phase 1

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Hormone therapy; Radiation: SBRT

• Registration Number: NCT04619069
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

This study is evaluating whether adding stereotactic radiotherapy (a new, more focused type of radiotherapy) to treat all the tumours that are present will improve outcomes or not compared to drugs alone for patients who are negative on conventional imaging and positive on PSMA PET scan

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-27
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. Age > 18 years.
2. Able to provide informed consent.
3. Histologic diagnosis of prostate adenocarcinoma.
4. ECOG performance status 0-1.
5. Stage IV hormone sensitive, synchronous or metachronous oligometastatic prostate cancer as detected by PSMA PET-CT scan with no metastases visible on conventional imaging (CT chest/abdomen/pelvis and bone scan +/- MRI) performed within 3 months of starting ADT.
6. Up to a maximum of 3 PSMA avid areas of metastatic disease.
7. For patients with metachronous disease, there must be a documented PSA rise. For those who had previous prostatectomy, PSA must be > 0.2 ng/mL. For those who had previous radical radiotherapy, PSA must have risen to at least 2 ng/mL above the nadir (Phoenix definition). The primary tumor must be controlled, with no PSMA avid progression within the primary prostate.
8. All sites of disease are amenable to and can be safely treated with SBRT.

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Exclusion Criteria

1. Significant comorbidities rendering patient not suitable for ADT and/or SBRT.
2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
3. Prior use of salvage or palliative intent ADT. Prior ADT use allowed only if it was delivered neoadjuvantly, concurrently, or adjuvantly with curative-intent treatment to the prostate or prostate bed (for patients with metachronous presentations), and at least 12 months have elapsed.
4. Castrate resistant prostate cancer.
5. Evidence of spinal cord compression.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Standard of Care	Hormone therapy	Intermittent Hormone treatment (minimum of 8 months)
Arm 2: SBRT to mets	SBRT	Intermittent Hormone treatment (minimum of 8 months) + SBRT to all sites of metastatic disease
Arm 2: SBRT to mets	Hormone therapy	Intermittent Hormone treatment (minimum of 8 months) + SBRT to all sites of metastatic disease

Primary Outcome Measures

Name	Time	Method
Proportion of eligible patients who enroll onto the study	Through accrual completion, approx 2 years	The primary purpose of this feasibility study is to measure the proportion of patients who are willing to enter this randomized trial

Secondary Outcome Measures

Name	Time	Method
Side Effects and Effectiveness	Through study completion, approx 5 years	An important secondary purpose is to measure the side effects and effectiveness of adding stereotactic radiotherapy to all sites of disease to intermittent hormone therapy compared to intermittent hormone therapy alone, using CTCAE v.5

Trial Locations

Locations (1)

Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada