Hormone Therapy + SBRT for Prostate Cancer

Overseen By Patrick Cheung

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: ADT

Disqualifiers: Castrate resistant, Recent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hormone Therapy + SBRT for Prostate Cancer?

Research shows that combining hormone therapy with stereotactic body radiation therapy (SBRT) can improve outcomes for prostate cancer patients. Studies have found that hormone therapy helps when used with radiotherapy, and SBRT is effective in delivering high doses of radiation to target cancer more precisely. ^{1 2 3 4 5}

Is hormone therapy combined with SBRT safe for treating prostate cancer?

Research shows that SBRT for prostate cancer is generally safe, with minimal acute side effects and low rates of severe late side effects. Studies have found that SBRT can be used safely with low toxicity, although long-term safety data is still being established. ^{6 7 8 9 10}

How does the treatment of hormone therapy combined with SBRT differ from other prostate cancer treatments?

This treatment is unique because it combines hormone therapy, which reduces testosterone levels to slow cancer growth, with stereotactic body radiation therapy (SBRT), a precise form of radiation that targets the tumor with high doses in fewer sessions, potentially reducing side effects compared to traditional methods. ^{2 11 12 13 14}

Eligibility Criteria

Men over 18 with hormone-sensitive, oligometastatic prostate cancer visible on PSMA PET-CT but not on conventional imaging. They must have a good performance status (able to carry out daily activities), up to 3 areas of metastasis treatable by SBRT, and controlled primary tumor without progression. Excluded are those with castrate-resistant cancer, spinal cord compression, recent ADT for palliation or other cancers in the past 5 years.

Inclusion Criteria

My cancer has spread to no more than 3 areas, as shown by a PSMA scan.

Able to provide informed consent.

I am fully active or can carry out light work.

Exclusion Criteria

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

I have health issues that make hormone therapy or radiation unsuitable for me.

I have used hormone therapy for prostate cancer over a year ago with the aim to cure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Intermittent hormone treatment with or without stereotactic body radiotherapy for a minimum of 8 months

8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Hormone therapy
• Stereotactic Body Radiotherapy

Trial Overview The trial is testing if adding stereotactic body radiotherapy (SBRT) to hormone therapy improves outcomes in patients with specific types of advanced prostate cancer that's still responsive to hormones and has limited spread as seen on specialized scans.

Participant Groups

Group I: Arm 2: SBRT to mets Experimental Treatment 2 Interventions

Intermittent Hormone treatment (minimum of 8 months) + SBRT to all sites of metastatic disease

Group II: Arm 1: Standard of Care Active Control 1 Intervention

Intermittent Hormone treatment (minimum of 8 months)

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Findings from Research

In a study of 44 prostate cancer patients treated with a combination of conventional pelvic radiation and an extreme hypofractionation SBRT boost, the five-year progression-free survival rate was an impressive 88.2%, indicating effective long-term control of the disease.

The treatment was associated with low rates of severe toxicity, with only 2.3% experiencing grade III or greater acute genitourinary and gastrointestinal side effects, suggesting that this approach is both effective and safe for patients with advanced prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II Study of Extreme Hypofractionated Stereotactic Body Radiation Therapy Boost to Prostate for Locally Advanced, Node-Positive and Oligometastatic Cancer. Narang, K., Kadian, M., Venkatesan, K., et al.[2021]

In a study of 230 men with early low-risk prostate cancer treated with stereotactic body radiotherapy (SBRT), the ten-year biochemical disease-free survival rate was an impressive 93%, indicating high efficacy of this treatment.

The treatment showed low toxicity, with only 10% of patients experiencing mild late urinary toxicity and 4% with late rectal toxicity, while quality of life scores for bowel and urinary function returned to baseline after initial declines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer: A Ten-Year Analysis. Katz, A.[2020]

In a study of 713 men treated with stereotactic body radiation therapy (SBRT) for localized prostate cancer, only 3% to 4% experienced significant long-term declines in health-related quality of life (HRQOL), indicating that SBRT has minimal long-term negative effects on overall well-being.

Factors such as lower baseline bowel HRQOL and depression were found to predict declines in HRQOL, suggesting that comorbid conditions may play a larger role in patient outcomes than the treatment itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of multidomain decline in health-related quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer. Dess, RT., Jackson, WC., Suy, S., et al.[2022]

The use of stereotactic body radiation therapy (SBRT) for low and intermediate risk prostate cancer increased dramatically from 0.9% in 2004 to 19.5% in 2015, indicating growing acceptance of this treatment method.

SBRT has been shown to have a favorable toxicity profile and efficacy, leading to a significant decline in conventional fractionation treatments, which dropped from 96.3% to 75.8% during the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current use of stereotactic body radiation therapy for low and intermediate risk prostate cancer: A National Cancer Database Analysis. Malouff, TD., Stross, WC., Seneviratne, DS., et al.[2021]

Stereotactic body radiation therapy (SBRT) and high-dose-rate brachytherapy (HDRBT) are effective modern treatments for prostate cancer, allowing for higher doses of radiation to be delivered precisely to the tumor while protecting surrounding healthy tissue.

These treatments are particularly beneficial for men with low- and intermediate-risk prostate cancer, as they can potentially shorten treatment duration while maintaining effective oncological outcomes and minimizing toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ablative Radiotherapy in Prostate Cancer: Stereotactic Body Radiotherapy and High Dose Rate Brachytherapy. Ma, TM., Lilleby, O., Lilleby, WA., et al.[2023]

Stereotactic body radiotherapy (SBRT) shows a high local control rate of 98.1% in treating oligorecurrent prostate cancer limited to lymph nodes, based on a systematic review of 363 patients across nine studies with a median follow-up of 19.23 months.

The treatment demonstrated a low incidence of toxicity, with only 5.6% of patients experiencing grade ≥2 adverse effects, and no cases of grade 4 toxicity, suggesting that SBRT is a safe option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring All Avenues for Radiotherapy in Oligorecurrent Prostate Cancer Disease Limited to Lymph Nodes: A Systematic Review of the Role of Stereotactic Body Radiotherapy. Ponti, E., Lancia, A., Ost, P., et al.[2022]

Stereotactic body radiation therapy (SBRT) resulted in significantly lower post-treatment PSA levels compared to intensity-modulated radiation therapy (IMRT) at 2 and 3 years, indicating better efficacy in controlling prostate cancer.

Both SBRT and IMRT showed similar overall survival rates after 5 years, but SBRT offers advantages such as lower cost and easier application, making it a suitable alternative for treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. Gao, QN.[2022]

Androgen deprivation therapy is the most common treatment for radio-recurrent prostate cancer, but it is only palliative and can have adverse effects due to testosterone suppression.

Stereotactic body radiation therapy (SBRT) offers a promising alternative by delivering high doses to tumors with precision, potentially reducing damage to surrounding tissues, although current data supporting its use is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retreatment for prostate cancer with stereotactic body radiation therapy (SBRT): Feasible or foolhardy? Arcangeli, S., Agolli, L., Donato, V.[2020]

In a study of 515 patients treated with stereotactic body radiation therapy (SBRT) for prostate cancer, the 7-year freedom from biochemical failure rates were excellent, with 95.8% for low-risk, 89.3% for intermediate-risk, and 68.5% for high-risk patients, indicating strong disease control.

The treatment was found to be safe, with no acute Grade 3 or 4 complications and low rates of late toxicity (4% for rectal and 9.1% for urinary Grade 2 toxicity), while quality of life measures returned to baseline within 2 years post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life and Toxicity after SBRT for Organ-Confined Prostate Cancer, a 7-Year Study. Katz, AJ., Kang, J.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Salvage Stereotactic Body Radiotherapy for Patients With Prostate Cancer With Isolated Lymph Node Metastasis: A Single-Center Experience. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Neoadjuvant hormonal therapy in men being treated with radiotherapy for localized prostate cancer. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Long-term results and PSA kinetics after robotic SBRT for prostate cancer: multicenter retrospective study in Korea (Korean radiation oncology group study 15-01). [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Phase I/II Study of Extreme Hypofractionated Stereotactic Body Radiation Therapy Boost to Prostate for Locally Advanced, Node-Positive and Oligometastatic Cancer. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer: A Ten-Year Analysis. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Predictors of multidomain decline in health-related quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy as boost for organ-confined prostate cancer. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Current use of stereotactic body radiation therapy for low and intermediate risk prostate cancer: A National Cancer Database Analysis. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Ablative Radiotherapy in Prostate Cancer: Stereotactic Body Radiotherapy and High Dose Rate Brachytherapy. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring All Avenues for Radiotherapy in Oligorecurrent Prostate Cancer Disease Limited to Lymph Nodes: A Systematic Review of the Role of Stereotactic Body Radiotherapy. [2022]

12. China pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. [2022]

13. Poland pubmed.ncbi.nlm.nih.gov

Retreatment for prostate cancer with stereotactic body radiation therapy (SBRT): Feasible or foolhardy? [2020]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Quality of Life and Toxicity after SBRT for Organ-Confined Prostate Cancer, a 7-Year Study. [2022]