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

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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Hormone therapy; Radiation: SBRT

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Patrick Cheung; Phone Number: 4164805000; Email: patrick.cheung@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Recruiting
      • Odette Cancer Centre
      • Contact: Patrick Cheung; Phone Number: 4164805000; Email: patrick.cheung@sunnybrook.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Standard of Care; Intermittent Hormone treatment (minimum of 8 months)	Drug: Hormone therapy; Intermittent Hormone Therapy per physician discretion (Min. 8 months)
Experimental: Arm 2: SBRT to mets; Intermittent Hormone treatment (minimum of 8 months) + SBRT to all sites of metastatic disease	Drug: Hormone therapy; Intermittent Hormone Therapy per physician discretion (Min. 8 months); Radiation: SBRT; SBRT to all sites of metastatic disease as seen on PSMA PET scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2027

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: iSTOP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No