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Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

ConditionsCastrate Resistance Prostate CancerOligoProgressive Metastatic Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-100
SponsorUniversity Health Network, Toronto

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

Able to provide informed consent

Histologic diagnosis of prostate adenocarcinoma

Castrate Resistance Prostate Cancer

Disqualifiers

Evidence of spinal cord compression

Contraindication to radiotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic Body Radiation Therapy (SBRT)

    Radiation

    SBRT will be delivered as per institutional standard.

  • Systemic therapy

    Other intervention

    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.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Arm 1 - Standard of CareActive comparator 2 interventions
Group B: Arm 2 - ExperimentalExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Study Feasibility

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).

Time frame
Within 18 months of study activation.
2

Change in Prostate-Specific Antigen (PSA)

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.

Time frame
Enrollment to 12 months post-enrollment.

Secondary outcomes

1

Radiographic Local Control of Oligopressive Lesions

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

Time frame
Enrollment to 12 months-post enrollment.
2

Radiographic Distant Control of Oligopressive Lesions

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

Time frame
Enrollment to 12-months post-enrollment.
3

Progression Free Survival (PFS)

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.

Time frame
Enrollment to 12-months post-enrollment.
4

Time to next Systemic Therapy

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.

Time frame
Enrollment to 12-months post-enrollment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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