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NCT Number: NCT06927635

Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

This is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves a change in ST) for patients with OP Castrate Resistance Prostate Cancer (CRPC).

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Key information

Conditions

Castrate Resistance Prostate Cancer OligoProgressive Metastatic Disease

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Rachel Glicksman, MD

CONTACT

[email protected]

416-946-4483

About this study

The current standard of care for patients with metastatic Oligopressive (OP) Castrate Resistance Prostate Cancer (CRPC) is a change in Systemic Therapy (ST). We propose that Stereotactic Body Radiotherapy (SBRT) to Oligopressive sites, while maintaining patients on their current Systemic Therapy, may allow for biochemical control of disease while maintaining patient Quality of Life and avoiding the toxicities associated with changing Systemic Therapy. We have proposed an initial prospective feasibility study, followed by a larger phase II prospective study to investigate the efficacy of SBRT in Oligopressive Castrate Resistance Prostate Cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years
  • Able to provide informed consent
  • Histologic diagnosis of prostate adenocarcinoma
  • Castrate Resistance Prostate Cancer
  • Radiographic evidence of <10 sites of extra-cranial OP metastatic lesions
  • Receiving any line of ST for >3 months
  • All sites of OP disease are amenable to and can be safely treated with SBRT
  • ECOG performance status 0-3

Exclusion criteria

  • Evidence of spinal cord compression
  • Contraindication to radiotherapy

Treatment and study plan

Stereotactic Body Radiation Therapy (SBRT)

Radiation

SBRT will be delivered as per institutional standard.

Systemic therapy

Other

Participants will receive Systemic Therapy. Participants in Arm 1 - SOC may change the Systemic Therapy throughout treatment. Participants in Arm 2 - Experimental will remain on the same Systemic Therapy throughout treatment.

Primary outcomes

  1. Study Feasibility

    Time frame: Within 18 months of study activation.

    Determine the feasibility of enrolling 21 patients patients onto a study randomizing patients to either MDT using SBRT plus remaining on current ST versus SoC (change in Systemic Therapy) by measuring the rate accrual (number of patients per month for 18 months).

  2. Change in Prostate-Specific Antigen (PSA)

    Time frame: Enrollment to 12 months post-enrollment.

    Assess by standard PSA blood testing if the proportion of patients having a >50% change in PSA compared to baseline (PSA50) is improved with MDT using SBRT plus remaining on current ST versus SoC.

Secondary outcomes

  1. Radiographic Local Control of Oligopressive Lesions

    Time frame: Enrollment to 12 months-post enrollment.

    Radiographic local control of the index OP lesions will be assessed by treating oncologist.

  2. Radiographic Distant Control of Oligopressive Lesions

    Time frame: Enrollment to 12-months post-enrollment.

    Defined by growth of non-Oligoprogressive metastatic sites and/or the development of new sites of metastatic disease, as assessed by treating oncologist.

  3. Progression Free Survival (PFS)

    Time frame: Enrollment to 12-months post-enrollment.

    Defined as the time from randomization to death from any cause, progression of disease, or date of last follow-up, whichever occurs first. PFS will be assessed by the treating oncologist.

  4. Time to next Systemic Therapy

    Time frame: Enrollment to 12-months post-enrollment.

    Defined as the time from when the study intervention has been commenced until commencement of any next systemic anti-cancer therapy (including a change to best supportive care) or date of last follow up, whichever occurs first, which will be assess by the treating oncologist.

  5. Differences in Toxicity

    Time frame: Enrollment to 12-months post-enrollment.

    Toxicity will be assessed to determine whether SBRT compared to SoC results in patient- and/or physician-reported toxicity differences. Toxicity will be collected using CTCAE v5.0

  6. Differences in Quality of Life

    Time frame: Enrollment to 12-months post-enrollment.

    Quality of Life (QoL) will be assessed to determine whether SBRT compared to SoC results in patient- and/or physician-reported QoL differences. QoL will be collected using the EORTC QLQ-C30 questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Glicksman, MD

CONTACT

[email protected]

416-946-4501 ext. 4961

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial

Acronym: SECURE

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 15, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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