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

NCT04619069 | Active Not Recruiting Phase 1

• 1 other identifier: iSTOP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Side Effects and Effectiveness

  Through study completion, approx 5 years

Study Arms (2)

Arm 1: Standard of Care

ACTIVE COMPARATOR

Intermittent Hormone treatment (minimum of 8 months)

Drug: Hormone therapy

Arm 2: SBRT to mets

EXPERIMENTAL

Intermittent Hormone treatment (minimum of 8 months) \+ SBRT to all sites of metastatic disease

Radiation: SBRT; Drug: Hormone therapy

Interventions

SBRT RADIATION

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

Arm 2: SBRT to mets

Hormone therapy DRUG

Intermittent Hormone Therapy per physician discretion (Min. 8 months)

Arm 1: Standard of Care; Arm 2: SBRT to mets

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate Cancer Patients only. Males only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Able to provide informed consent.
• Histologic diagnosis of prostate adenocarcinoma.
• ECOG performance status 0-1.
• 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.
• Up to a maximum of 3 PSMA avid areas of metastatic disease.
• 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.
• All sites of disease are amenable to and can be safely treated with SBRT.

You may not qualify if:

• Significant comorbidities rendering patient not suitable for ADT and/or SBRT.
• History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
• 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.
• Castrate resistant prostate cancer.
• Evidence of spinal cord compression.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 6, 2020
• Study Start: October 27, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-03

Locations

CA (1)