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Radiation Therapy

SABR for Prostate Cancer

N/A

Recruiting

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation of metastatic, castration-resistant prostate cancer

ECOG performance status 0-1

Must not have

Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.

Patients presenting with unequivocal clinical progression, defined as one of the following: (i) cancer pain requiring the initiation of opioid therapy; (ii) immediate need for cytotoxic chemotherapy as per treating physician's discretion; or (iii) deterioration of performance status to grade ≥ 3 according to ECOG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is exploring the use of SABR to treat men with prostate cancer who have oligoprogressive metastases.

Who is the study for?

This trial is for men with prostate cancer that's spread but mostly under control while on abiraterone, except for up to 5 'rogue' tumors getting worse. They should be fairly active (ECOG 0-1), have a confirmed diagnosis, and all progressing spots can be targeted by SABR. Men with spinal cord compression, recent cancers besides skin or in-situ types, or severe symptoms needing immediate other treatments can't join.

What is being tested?

The study tests if Stereotactic Ablative Radiation Therapy (SABR) can target few worsening metastases in prostate cancer patients resistant to abiraterone without changing their current systemic therapy. The goal is to see if this approach delays the need for new systemic treatments and helps control the disease longer.

What are the potential side effects?

SABR may cause side effects like fatigue, skin reactions at the treatment site, nausea, urinary issues due to inflammation of bladder or urethra, bowel discomfort from intestinal irritation and potential damage to nearby organs depending on where radiation targets.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has spread and is not responding to hormone therapy.

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I am fully active or can carry out light work.

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I am currently being treated with abiraterone.

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My prostate cancer has been confirmed through a biopsy.

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My cancer spread can be treated with targeted radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had cancer, except for non-dangerous skin cancer or in-situ cancer, in the last 5 years.

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My cancer has worsened, needing strong painkillers, immediate chemotherapy, or has greatly affected my daily activities.

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I have been diagnosed with spinal cord compression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival

SABR-related toxicities

Secondary study objectives

Biochemical progression-free survival

Overall survival

Quality of Life (QoL) assessment

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

All metastases that fulfill the definition of oligoprogression seen on conventional imaging will be treated with standard SABR dose fractionation schemes routinely used at Sunnybrook Odette Cancer Centre. The prostate (if present and not previously treated) will be treated to a dose of 35 Gy in 5 fractions. Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Spine metastases will be treated to a dose of 24 Gy in 2-3 fractions or 30-40 Gy in 5 fractions. Involved lymphadenopathy will be treated to a dose of 30-40 Gy in 5 fractions. Similarly, brain, lung, liver, and adrenal metastases will be treated with standard Sunnybrook SABR doses. Patients will remain on abiraterone during and after SABR treatments.

0 / 8Eligibility criteria met