Radiotherapy for Prostate Cancer

(AMPORA Trial)

Overseen By Andrew McPartlin, MBChB

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Disqualifiers: Prior pelvic radiotherapy, Mets, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4-5 weeks

204 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-institution, randomized, non-inferiority Phase II trial comparing external beam radiotherapy delivered as 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily with external beam radiotherapy delivered as 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.

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 Proton Beam Therapy for prostate cancer?

Proton Beam Therapy (PBT) is shown to have unique properties that allow it to target prostate cancer effectively while minimizing damage to surrounding healthy tissues. Studies suggest that PBT can provide good disease control and maintain quality of life, although more research is needed to compare it directly with other treatments like photon-based radiation and brachytherapy. ^{1 2 3 4 5}

Is proton beam therapy (PBT) safe for treating prostate cancer?

Proton beam therapy (PBT) for prostate cancer has been studied for its safety, focusing on side effects like rectal toxicities and patient-reported quality of life. Research shows that PBT can target cancer cells while minimizing damage to surrounding healthy tissues, suggesting it is generally safe, though some side effects may occur. ^{2 3 5 6 7}

How is proton beam therapy different from other treatments for prostate cancer?

Proton beam therapy (PBT) is unique because it can deliver higher doses of radiation directly to the prostate cancer while minimizing exposure to surrounding healthy tissues, potentially reducing side effects. This is due to its precise dose deposition properties, which differ from other radiation therapies like intensity modulated radiation therapy (IMRT). ^{1 3 5 8 9}

Eligibility Criteria

This trial is for men over 18 who've had prostate surgery at least 6 months ago and are now set to receive post-op radiation. They should be relatively active (able to walk around and take care of themselves) with a confirmed diagnosis of prostate adenocarcinoma.

Inclusion Criteria

I am older than 18 years.

Able to provide informed consent

I am fully active or can carry out light work.

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

I cannot undergo radiotherapy due to health reasons.

Mets confirmed as per (if scan has been done for clinical care)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive external beam radiotherapy, either 54 Gy in 20 fractions delivered daily or 30 Gy in 5 fractions delivered on alternate days

4-5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of acute and late toxicity, quality of life, and disease control

2 years

Treatment Details

Interventions

• Proton Beam Therapy

Trial Overview The study compares two radiotherapy schedules for prostate cancer after surgery: one delivers a total dose daily in smaller parts over several weeks, while the other gives larger doses every other day in fewer sessions.

Participant Groups

Group I: Arm 2: Ultrahypofractionated Radiotherapy Experimental Treatment 1 Intervention

External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.

Group II: Arm 1: Moderately Hypofractionated Radiotherapy Experimental Treatment 1 Intervention

External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily.

Proton Beam Therapy is already approved in United States, European Union, Japan, Canada for the following indications:

Approved in United States as Proton Beam Therapy for:

• Various cancers including prostate, breast, lung, liver, and head and neck cancers

Approved in European Union as Proton Therapy for:

• Various cancers including ocular melanoma, chordomas, chondrosarcomas, and certain pediatric cancers

Approved in Japan as Proton Beam Therapy for:

• Various cancers including prostate, liver, and ocular melanoma

Approved in Canada as Proton Therapy for:

• Various cancers including ocular melanoma and certain pediatric cancers

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 295 men who underwent postoperative radiation therapy for prostate cancer, proton beam therapy (PBT) showed similar long-term disease control outcomes compared to intensity-modulated radiation therapy (IMRT) after a median follow-up of 59 months.

Both treatment modalities had comparable rates of biochemical failure, local failure, regional failure, distant failure, and all-cause mortality, indicating that PBT is as effective as IMRT in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Analysis of 5-Year Clinical Outcomes and Patterns of Failure of Proton Beam Therapy Versus Intensity Modulated Radiation therapy for Prostate Cancer in the Postoperative Setting. Barsky, AR., Carmona, R., Verma, V., et al.[2021]

In a study of 423 men treated with proton beam therapy (PBT) for prostate cancer, the 5.2-year follow-up showed an impressive overall survival rate of 99.8% and a disease-specific survival rate of 100%, indicating high efficacy of this treatment.

While acute toxicity was relatively low, with no severe grade ≥3 complications, there was a modest but clinically significant decrease in bowel quality of life scores after treatment, suggesting that while PBT is effective, it may still impact certain aspects of quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy for Localized Prostate Cancer: Results from a Prospective Quality-of-Life Trial. Pugh, TJ., Choi, S., Nogueras-Gonzalaez, GM., et al.[2022]

Proton beam therapy (PBT) allows for higher radiation doses to be delivered to prostate cancer tissues while reducing exposure to surrounding healthy organs, making it a safer option for treatment.

Interest in PBT is growing due to improvements in treatment delivery systems and increased availability, highlighting the need for a comprehensive understanding of its effectiveness and technical aspects in treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam therapy for the treatment of prostate cancer. Pugh, TJ., Lee, AK.[2018]

In a study of 276,880 men with localized prostate cancer, proton beam therapy (PBT) was associated with significantly better overall survival (OS) compared to photon-based external-beam radiation therapy (EBRT), with an adjusted hazard ratio of 1.72, indicating a higher risk of worse outcomes with EBRT.

PBT showed similar OS outcomes to brachytherapy (BT), particularly benefiting younger men (≤ 65 years) with low-risk disease, suggesting that PBT may be a more effective treatment option for certain patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall Survival After Treatment of Localized Prostate Cancer With Proton Beam Therapy, External-Beam Photon Therapy, or Brachytherapy. Liu, Y., Patel, SA., Jani, AB., et al.[2021]

In a study of 151 patients with organ-confined prostate cancer, proton beam therapy (PBT) demonstrated a low incidence of late Grade 2 or greater rectal toxicities, reported at only 2.0% after 2 years of follow-up.

The study indicates that PBT is a safe treatment option for localized prostate cancer, with minimal acute and late toxicities, suggesting it can effectively control side effects while delivering targeted radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional Phase II study of proton beam therapy for organ-confined prostate cancer focusing on the incidence of late rectal toxicities. Nihei, K., Ogino, T., Onozawa, M., et al.[2022]

In a study of 192 prostate cancer patients treated with proton beam therapy (PBT) over a median follow-up of 1.7 years, only 5 patients experienced grade 3 toxicity, with no occurrences of grade 4 or 5 toxicity, indicating a high safety profile for this treatment.

Patient-reported outcomes showed stable urinary function post-treatment, while sexual health scores declined slightly at 1 year but did not worsen thereafter; bowel function scores also decreased but stabilized, suggesting manageable side effects associated with PBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early toxicity and patient reported quality-of-life in patients receiving proton therapy for localized prostate cancer: a single institutional review of prospectively recorded outcomes. Lee, HJ., Macomber, MW., Spraker, MB., et al.[2019]

In a study of 289 prostate cancer patients, hypofractionated proton beam therapy (PBT) showed no significant differences in acute adverse event rates or quality of life, as measured by the International Prostate Symptom Score (IPSS), compared to conventionally fractionated PBT.

The study evaluated patients treated with different doses (2.0, 2.5, and 3.0 Gy RBE per fraction) and found that factors like diabetes, age, and androgen deprivation therapy did not influence the IPSS outcomes, suggesting that hypofractionated PBT is a safe option without increased toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. Iizumi, T., Ishikawa, H., Sekino, Y., et al.[2022]

Proton beam therapy (PBT) allows for higher doses of radiation to be delivered to prostate cancer tissues while minimizing damage to surrounding healthy tissues, making it a promising treatment option.

The review highlights the growing interest and advancements in PBT technology for localized prostate cancer, emphasizing the need for a deeper understanding of its application and treatment planning in radiation medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam therapy for the treatment of prostate cancer. Pugh, TJ., Choi, S., Nguyen, QN., et al.[2016]

Proton beam therapy (PBT) for prostate cancer patients receiving pelvic radiation significantly reduces acute gastrointestinal (GI) toxicity compared to intensity modulated radiation therapy (IMXT), with rates of grade 1, 2, and 3 GI toxicity at 16.4%, 2.4%, and 0%, respectively.

The study involved 85 patients with a median follow-up of 14.5 months, and while GU toxicity was higher, the results suggest that PBT may spare the small bowel, leading to less GI side effects, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal toxicity after proton beam therapy for prostate and pelvic nodal irradiation: results from the proton collaborative group REG001-09 trial. Chuong, MD., Hartsell, W., Larson, G., et al.[2018]

References

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

Comparative Analysis of 5-Year Clinical Outcomes and Patterns of Failure of Proton Beam Therapy Versus Intensity Modulated Radiation therapy for Prostate Cancer in the Postoperative Setting. [2021]

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

Proton Beam Therapy for Localized Prostate Cancer: Results from a Prospective Quality-of-Life Trial. [2022]

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

Proton beam therapy for the treatment of prostate cancer. [2018]

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

Overall Survival After Treatment of Localized Prostate Cancer With Proton Beam Therapy, External-Beam Photon Therapy, or Brachytherapy. [2021]

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

Multi-institutional Phase II study of proton beam therapy for organ-confined prostate cancer focusing on the incidence of late rectal toxicities. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Early toxicity and patient reported quality-of-life in patients receiving proton therapy for localized prostate cancer: a single institutional review of prospectively recorded outcomes. [2019]

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

Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. [2022]

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

Proton beam therapy for the treatment of prostate cancer. [2016]

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

Minimal toxicity after proton beam therapy for prostate and pelvic nodal irradiation: results from the proton collaborative group REG001-09 trial. [2018]