Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer

NCT03784755 | Active Not Recruiting DMC

• 1 other identifier: PR20
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 18

Brief Summary

The purpose of this study is to compare the effects of ablative therapy (radiation or surgery) to all sites of disease combined with standard treatments on prostate cancer, compared to the standard or usual treatments used to treat this disease.

Conditions

Prostate Cancer Metastatic

Keywords

Oligometastatic Hormone

Outcome Measures

Primary Outcomes (1)

• Failure-free Survival

  defined as the time from randomization to the time of the first occurrence.

  12 years

Secondary Outcomes (9)

• Radiographic Progression-free Survival

  12 years

• Incidence of new metastases as first event

  12 years

• Overall Survival

  12 years

• Ablative treatment related adverse events (>/= grade 3) using CTCAE v5.0

  12 years

• Quality of Life measured by EORTC QLQ-C30

  12 years

Study Arms (2)

Arm 1 (standard of care)

ACTIVE COMPARATOR

Standard systemic therapy \+ Ablative therapy to untreated prostate primary for patients with low volume metastatic disease burden

Other: Standard of care

Arm 2 (standard systemic therapy + ablative therapy))

EXPERIMENTAL

Local Ablative therapy to all sites of disease (including untreated prostate primary) \+ Standard systemic therapy

Radiation: Ablative Radiation Therapy; Other: Standard of care

Interventions

Ablative Radiation Therapy RADIATION

Undergo stereotactic radiotherapy and/or surgery to all sites of disease (oligometastases and primary prostate if previously untreated).

Also known as: SBRT, Stereotactic External Beam Irradiation, Stereotactic Radiation Therapy, Stereotactic Radiotherapy

Arm 2 (standard systemic therapy + ablative therapy))

Standard of care OTHER

Patients continue to receive their current planned systemic therapy at the discretion of the treating physician

Arm 1 (standard of care); Arm 2 (standard systemic therapy + ablative therapy))

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis/confirmation of prostate adenocarcinoma and no evidence of small cell cancer.
• Stage IV at presentation or relapse after curative intent therapy, classification per AJCC 8th edition: M1 disease with ≤ 5 metastases
• ≤ 3 metastases in any non-bone organ system
• Zoladex must commence within 12 weeks prior to randomization or within 12 weeks after randomization.
• Radiology (CT/MRI chest/abdomen/pelvis) within 42 days of randomization
• Bone scan within 42 days of randomization
• All tumours (Primary prostate and metastases) must be amenable to local ablative therapy (radiation and/or surgery).
• Age ≥ 18
• ECOG performance 0-2
• Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and economics questionnaires in either English or French
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
• Patients must be medically suitable for study treatments as assessed by the appropriate specialties: medical, radiation, and surgical
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
• Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
• In accordance with CCTG policy, ablative therapy to metastases is to begin within 6 weeks after patient randomization

You may not qualify if:

• Prior treatment with ADT in the neoadjuvant or adjuvant setting, unless treatment was discontinued ≥ 12 months prior to randomization AND total duration of treatment was ≤ 36 months (including expiry of last depot injection).
• Previously diagnosed recurrent/metastatic disease which has been already treated with any systemic therapy or radiotherapy with palliative intent.
• Castration resistant prostate cancer, defined as rising PSA (per PCWG3) or radiographic progression in the setting of castrate levels of serum testosterone (\< 1.7 nmol/L).
• Patients who present with de novo stage IV disease with pelvic lymphadenopathy as their only site of metastases (N1 M0), where the primary prostate has never been treated with curative intent prostate surgery or radiotherapy in the past.
• Inability to treat all sites of disease with local ablative therapy
• Patients with parenchymal brain metastases

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (18)

BCCA - Victoria

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Trillium Health Partners - Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Algoma District Cancer Program

Sault Ste. Marie, Ontario, P6B 0A8, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

CIUSSS de l'Est-de-I'lle-de-Montreal

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Interventions

Radiosurgery; Standard of Care

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Patrick CF Cheung

  Odette Cancer Centre, Sunnybrook Health Science Centre, Toronto, ON Canada

  STUDY CHAIR

• M. Tamim Niazi

  The Jewish General Hospital, Montreal, QC Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 24, 2018
• Study Start: November 15, 2019
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): July 30, 2033
• Last Updated: March 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (18)