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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation therapy for men with high-risk prostate cancer that hasn't spread beyond nearby lymph nodes. The treatment uses a focused radiation boost to the prostate area through external beam radiotherapy, which delivers radiation from a machine outside the body. The researchers aim to determine if this method can effectively target cancer cells while minimizing side effects. It suits men diagnosed with localized high-risk prostate cancer, particularly those whose tumors haven't received prior radiation treatment. As an unphased trial, it allows patients to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that this radiotherapy technique is safe for prostate cancer patients?

Research has shown that using fewer but larger doses of external beam radiotherapy for prostate cancer is generally well-tolerated by patients. Studies have found that this treatment can be administered safely and effectively with fewer sessions. Reports indicate that side effects, particularly those affecting the urinary and digestive systems, remain manageable and acceptable. These findings suggest that this treatment could be a safe option for individuals with localized high-risk or node-positive prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of moderate hypofractionated boost radiotherapy for prostate cancer because it offers a different approach from traditional methods. Unlike standard treatments that often involve longer courses of radiotherapy, this method delivers higher doses over fewer sessions, potentially improving convenience for patients. Additionally, the technique allows for targeted boosts to specific areas like the dominant intraprostatic lesion and involved lymph nodes, which could enhance effectiveness by focusing on the most affected regions. This targeted and time-efficient approach may lead to better outcomes with fewer side effects, making it a promising option for prostate cancer patients.

What evidence suggests that this radiotherapy is effective for prostate cancer?

Research shows that external beam radiotherapy (EBRT) is as effective as surgery for treating prostate cancer. Studies have found that delivering higher doses of radiation over fewer sessions, known as moderately hypofractionated radiotherapy, effectively treats prostate cancer. This method achieves similar results to traditional radiation but requires less time. Other studies found no major differences in quality of life or side effects when comparing different radiation methods. Overall, evidence supports this radiation approach as effective for high-risk prostate cancer. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05313815

Moderate Hypofractionated Boost to the Prostate With ... Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6223284/

Moderately hypofractionated prostate external-beam ... External beam radiotherapy (EBRT) has been proven to have equivalent efficacy compared with radical prostatectomy for the definitive management of prostate ...

3. ctro.science ctro.science/article/S2405-6308(24)00123-X/fulltext

Moderately hypofractionated prostate-only versus whole- ... Moderately hypofractionated WPRT did not improve oncological outcomes. •. No observed difference in QoL, GI, or sexual toxicity between PORT and ...

4. medicaljournalssweden.se medicaljournalssweden.se/SJU/article/download/7719/19061/56119

Current evidence for moderate and ultra-hypofractionated ... Data from large randomised control trials (RCTs) comparing moderate hypofractionated (MHRT, 2.4–3.4 Gray/fraction (Gy/fx)) and ultra-hypof- ractionated (UHRT, > ...

5. urotoday.com urotoday.com/library-resources/prostate-cancer-active-surveilance/140262-radiotherapy-in-prostate-cancer-hypofractionation-for-clinically-localized-disease.html

Radiotherapy in Prostate Cancer: Hypofractionation for ... Classically, external beam radiotherapy has been administered in a non-fractionated schedule of 1.8 – 2.0 Gy per day, five days per week for 6 to 8 weeks.

6. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-021-01976-2

Safety of accelerated hypofractionated whole pelvis radiation ... Accelerated, hypofractionated whole pelvis radiotherapy was associated with acceptable GU and GI toxicities and should be further validated for those at risk ...

7. link.springer.com link.springer.com/article/10.1007/s00066-023-02104-7

Assessing the toxicity after moderately hypofractionated ... With this study, we provided more data on the effects of hypofractionation at a specific dose for WPRT. Our results demonstrated that moderately ...