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

Prostate Cancer Clinical Trial

Official title:

Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer: A Randomized Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04619069
• Other study ID #: iSTOP
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 27, 2020
• Est. completion date: October 2027

Study information

• Verified date: May 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2027
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• SBRT
SBRT to all sites of metastatic disease as seen on PSMA PET scan

Drug:
• Hormone therapy
Intermittent Hormone Therapy per physician discretion (Min. 8 months)

Locations

Country	Name	City	State
Canada	Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eligible patients who enroll onto the study	The primary purpose of this feasibility study is to measure the proportion of patients who are willing to enter this randomized trial	Through accrual completion, approx 2 years
Secondary	Side Effects and Effectiveness	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	Through study completion, approx 5 years