Radiotherapy for Prostate Cancer

(MOB-RT Trial)

Overseen By Rachel Glicksman, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Prior pelvic radiotherapy, Contraindications to radiotherapy

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment for high-risk prostate cancer using high-energy X-rays to target and kill cancer cells in the prostate and pelvic area. Some patients may also receive hormone therapy to lower testosterone levels, which can help slow cancer growth. The goal is to see if this combined approach is effective for patients who are at a higher risk of their cancer spreading or not responding to standard treatments.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of this treatment for prostate cancer?

Research shows that using a combination of whole-pelvis irradiation and a focused boost to the prostate can increase the effectiveness of the treatment without adding extra side effects. This approach has been shown to be effective in treating high-risk localized prostate cancer, with studies reporting positive results over several years. ^{1 2 3 4 5}

Is hypofractionated radiotherapy for prostate cancer safe?

Research shows that hypofractionated radiotherapy, including techniques like external beam radiotherapy (EBRT) and stereotactic body radiotherapy (SBRT), can be used safely for prostate cancer without increasing toxicity. Studies have evaluated its safety over several years, indicating it is generally well-tolerated in humans. ^{1 2 3 5 6}

How is the treatment of moderate hypofractionated boost to the prostate with pelvic RT different from other prostate cancer treatments?

This treatment is unique because it combines a higher dose of radiation to the prostate with a lower dose to the surrounding pelvic area in fewer sessions, potentially increasing effectiveness without adding side effects. It uses advanced techniques to target the cancer more precisely, which may be beneficial for patients with high-risk prostate cancer. ^{1 2 3 7 8}

Eligibility Criteria

This trial is for men over 18 with high-risk localized prostate cancer or node-positive disease, who are generally in good health (ECOG status 0-1). They must not have had previous pelvic radiotherapy and should be free of metastatic disease as confirmed by imaging. Participants can give informed consent and may receive hormone therapy if their doctor thinks it's necessary.

Inclusion Criteria

My scans show no signs of cancer spread beyond the prostate.

I have been diagnosed with prostate cancer.

I am older than 18 years.

Exclusion Criteria

I cannot undergo radiotherapy due to health reasons.

I have had radiation therapy to my pelvic area before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive external beam radiotherapy: 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, with optional boosts

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 weeks post-intervention and every 6 months until 5 years

5 years

Treatment Details

Interventions

• Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)

Trial Overview The study is testing a specific type of radiation treatment called moderate hypofractionated boost to the prostate along with pelvic RT. It's designed for patients with serious forms of prostate cancer that hasn't spread beyond the pelvis. The trial will observe how well this intensified radiation approach works.

Participant Groups

Group I: Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy Experimental Treatment 1 Intervention

External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes

Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as External Beam Radiotherapy (EBRT) for:

• Prostate cancer
• Localized high-risk prostate cancer
• Node-positive prostate cancer

Approved in United States as External Beam Radiotherapy (EBRT) for:

• Prostate cancer
• Localized high-risk prostate cancer
• Node-positive prostate cancer

Approved in Canada as External Beam Radiotherapy (EBRT) for:

• Prostate cancer
• Localized high-risk prostate cancer
• Node-positive prostate cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 41 patients with high-risk localized prostate cancer, combining whole-pelvis irradiation with a stereotactic body radiotherapy (SBRT) boost resulted in a high 4-year biochemical failure-free survival rate of 91.9%, indicating effective cancer control.

The treatment was associated with minimal toxicity, with no severe (grade 3) gastrointestinal or genitourinary side effects reported, suggesting that this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Lin, YW., Lin, LC., Lin, KL.[2020]

External beam radiotherapy is a common treatment for localized prostate cancer, and hypofractionation is emerging as a viable alternative to traditional radiotherapy methods.

The simultaneous integrated boost technique allows for a higher dose to the prostate while simultaneously delivering a lower dose to pelvic nodes, potentially improving treatment outcomes for patients at risk of cancer spread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elective Pelvic Nodal Irradiation With a Simultaneous Hypofractionated Integrated Prostate Boost for Localised Prostate Cancer: Ready for Prime Time? Cheung, P., Niazi, T., Faria, S., et al.[2020]

Accelerated hypofractionated external beam radiotherapy combined with high-dose rate brachytherapy effectively delivered high radiation doses to prostate cancer patients, achieving high overall survival and biochemical control rates over an 8-year follow-up period.

Adding up to 6 months of androgen deprivation therapy did not improve outcomes and was associated with increased rates of metastasis and cancer-related deaths, raising concerns about its use in conjunction with high-dose radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of benefit from a short course of androgen deprivation for unfavorable prostate cancer patients treated with an accelerated hypofractionated regime. Martinez, AA., Demanes, DJ., Galalae, R., et al.[2018]

Postoperative external beam radiation therapy (EBRT) using hypofractionation shows a favorable acute toxicity profile and comparable biochemical control rates for prostate cancer patients after radical prostatectomy, based on a systematic review of the literature.

However, there are conflicting reports regarding long-term genitourinary toxicity, indicating that more prospective studies are needed to fully understand the safety and efficacy of hypofractionation in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for prostate cancer in the postoperative setting: What is the evidence so far? Picardi, C., Perret, I., Miralbell, R., et al.[2018]

In a study of 76 patients with intermediate-risk prostate cancer, the combination of external beam radiation therapy (EBRT) and hypofractionated stereotactic boost (SBRT) showed excellent tolerance, with only 1.4% experiencing significant genitourinary toxicities and 9.3% experiencing gastrointestinal toxicities after 5 years.

The treatment resulted in high efficacy, with 5-year biochemical relapse-free survival rates of 87.4% and overall relapse-free survival rates of 86.2%, indicating that this approach is both safe and effective for managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter Phase 2 study of Hypofractionated Stereostatic Boost in Intermediate Risk Prostate Carcinoma: A 5-Year Analysis of the CKNO-PRO Trial. Pasquier, D., Peiffert, D., Nickers, P., et al.[2020]

In a clinical trial involving 42 men with intermediate-risk prostate cancer, a treatment combining a single 15 Gy HDR brachytherapy boost with a five-fraction external beam radiation therapy (EBRT) resulted in a high biochemical disease-free survival rate of 95.5% after a median follow-up of 36 months.

The treatment demonstrated low toxicity, with only one case of acute Grade 3 gastrointestinal and genitourinary toxicity, and no significant differences in health-related quality of life across urinary, bowel, or sexual domains, suggesting it is a safe and effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase IB clinical trial of 15 Gy HDR brachytherapy followed by hypofractionated/SBRT in the management of intermediate-risk prostate cancer. Den, RB., Greenspan, J., Doyle, LA., et al.[2023]

This ongoing phase II clinical study is investigating an ultra-hypofractionated radiotherapy scheme for low- or intermediate-risk prostate cancer patients, focusing on the feasibility and incidence of acute side effects.

The study aims to assess not only the immediate tolerability of the treatment but also its long-term effects on quality of life and oncological outcomes, with expectations of good tolerability and effectiveness based on previous research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and protocol of AIRC IG-13218, short-term radiotherapy for early prostate cancer with concomitant boost to the dominant lesion. Timon, G., Ciardo, D., Bazani, A., et al.[2018]

In a study of 54 prostate cancer patients treated with either hypofractionated external beam radiation (HypoF) or standard fractionation (SF) combined with high-dose-rate brachytherapy (HDR), there were no significant differences in quality of life outcomes, including urinary and bowel function, between the two treatment groups over time.

The findings suggest that HypoF EBRT can be safely combined with HDR for treating intermediate and high-risk prostate cancer without increasing toxicity compared to standard fractionation, indicating its potential as an effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated external beam radiation therapy in combination with HDR boost for localized prostate cancer: patient reported quality of life outcomes. Morgan, TM., Press, RH., Cutrell, PK., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Elective Pelvic Nodal Irradiation With a Simultaneous Hypofractionated Integrated Prostate Boost for Localised Prostate Cancer: Ready for Prime Time? [2020]

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

Lack of benefit from a short course of androgen deprivation for unfavorable prostate cancer patients treated with an accelerated hypofractionated regime. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for prostate cancer in the postoperative setting: What is the evidence so far? [2018]

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

A Multicenter Phase 2 study of Hypofractionated Stereostatic Boost in Intermediate Risk Prostate Carcinoma: A 5-Year Analysis of the CKNO-PRO Trial. [2020]

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

A phase IB clinical trial of 15 Gy HDR brachytherapy followed by hypofractionated/SBRT in the management of intermediate-risk prostate cancer. [2023]

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

Rationale and protocol of AIRC IG-13218, short-term radiotherapy for early prostate cancer with concomitant boost to the dominant lesion. [2018]

8. Poland pubmed.ncbi.nlm.nih.gov

Hypofractionated external beam radiation therapy in combination with HDR boost for localized prostate cancer: patient reported quality of life outcomes. [2022]