Radiation Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Chemotherapy

Disqualifiers: Bone metastases, Visceral metastases, 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

Compensation: Varies

Number of Visits: 3

Duration: 3-5 weeks

84 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those taking concurrent chemotherapy. It's best to discuss your specific medications with the trial team.

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

Research shows that both intensity-modulated radiation therapy (IMRT) and proton beam therapy (PBT) are effective for controlling localized prostate cancer over the long term. Additionally, intensity-modulated proton therapy (IMPT) can reduce the risk of secondary cancer by limiting radiation exposure to healthy tissue. ^{1 2 3 4 5}

Is radiation therapy for prostate cancer safe?

Both Intensity-Modulated Radiation Therapy (IMRT) and Proton Beam Therapy (PBT) are generally safe for treating prostate cancer, with PBT potentially causing less damage to nearby organs. Studies show minimal side effects, but patient positioning during IMRT is important to avoid rectal issues. ^{1 6 7 8 9}

How does the treatment of IMRT and Proton Beam Therapy for prostate cancer differ from other treatments?

IMRT (Intensity-Modulated Radiation Therapy) and Proton Beam Therapy are advanced forms of radiation treatment for prostate cancer that allow for precise targeting of the tumor, minimizing damage to surrounding healthy tissue. Proton Beam Therapy, in particular, uses protons instead of X-rays, which can reduce side effects and potentially improve outcomes compared to traditional radiation methods. ^{1 3 5 6 10}

What is the purpose of this trial?

This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or IMRT) for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated proton beam radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent prostate cancer.

Research Team

Brian J. Davis, M.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

Men over 18 with recurrent prostate cancer limited to certain lymph nodes, who've had primary radiotherapy. They must have a good performance status (able to carry out daily activities) and no bone or visceral metastases, other recent malignancies, or conditions that prevent radiation therapy or informed consent.

Inclusion Criteria

My cancer is only in my pelvic or nearby lymph nodes.

My prostate cancer has been confirmed through a biopsy.

My prostate cancer has returned after I had radiation therapy.

Exclusion Criteria

My cancer has spread to my bones or internal organs.

I cannot undergo treatments that lower testosterone levels.

I can start radiation treatment within 6 months after joining the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either proton beam radiation therapy or IMRT 5 days a week

3-5 weeks

Daily visits (in-person) for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Follow-up visits at 3-6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months

Treatment Details

Interventions

• Intensity-Modulated Radiation Therapy
• Proton Beam Radiation Therapy

Trial Overview The trial is testing two types of radiation: Hypofractionated Proton Beam Therapy which gives smaller doses over time, and IMRT which uses high-energy x-rays. The goal is to see if a shorter course of radiation can effectively treat recurrent prostate cancer with fewer side effects.

Participant Groups

Group I: Arm II (IMRT) Experimental Treatment 5 Interventions

Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.

Group II: Arm I (proton beam radiation therapy) Experimental Treatment 6 Interventions

Patients undergo proton beam radiation therapy 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.

Intensity-Modulated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as IMRT for:

• Oropharyngeal cancer
• Head and neck cancers
• Prostate cancer
• Breast cancer
• Lung cancer

Approved in European Union as IMRT for:

• Oropharyngeal cancer
• Head and neck cancers
• Prostate cancer
• Breast cancer
• Lung cancer

Approved in Canada as IMRT for:

• Oropharyngeal cancer
• Head and neck cancers
• Prostate cancer
• Breast cancer
• Lung cancer

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study involving 8 patients, intensity modulated radiation therapy (IMRT) generally outperformed standard bilateral proton therapy in protecting normal tissues, especially when using a fixed relative biological effectiveness (RBE) of 1.1.

The research highlights the need for further validation of RBE models, as using variable RBE assumptions with anterior oblique proton therapy often resulted in excessive radiation exposure to the rectum, raising concerns about its safety for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can We Advance Proton Therapy for Prostate? Considering Alternative Beam Angles and Relative Biological Effectiveness Variations When Comparing Against Intensity Modulated Radiation Therapy. Underwood, T., Giantsoudi, D., Moteabbed, M., et al.[2022]

Intensity-modulated proton therapy (IMPT) was found to irradiate only half the tissue volume with a lower dose compared to intensity-modulated x-ray therapy (IMXT), which could reduce the risk of secondary cancers and complications.

Both treatment plans were effective in covering target volumes for patients with advanced prostate carcinoma, indicating that IMPT can be a safer alternative without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LOW DOSE BATH FROM IMPT VS. IMXT FOR THE PELVIC AREA WHEN TREATING ADVANCED PROSTATE CANCER. Navrátil, M., Vondráček, V., Andrlík, M., et al.[2020]

Intensity-modulated photon radiotherapy (IMRT) provided better dose conformity to the prostate cancer target compared to three-dimensional conformal proton therapy (3D-CPT), while both methods effectively delivered the prescribed dose to at least 98% of the target volume.

Proton therapy, particularly with optimized configurations, significantly reduced radiation exposure to the bladder and rectum at lower doses, indicating a potential advantage in sparing healthy tissues during prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy treatment of early-stage prostate cancer with IMRT and protons: a treatment planning comparison. Trofimov, A., Nguyen, PL., Coen, JJ., et al.[2020]

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]

In a study involving 394 patients with localized prostate cancer, proton beam therapy (PBT) showed lower dosimetry for bladder and rectum compared to intensity-modulated radiation therapy (IMRT), suggesting a potential for reduced exposure to surrounding tissues.

However, after matching patients on risk factors and adjusting for confounders, there were no significant differences in the rates of acute or late gastrointestinal and genitourinary toxicities between PBT and IMRT, indicating similar safety profiles for both treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case-matched study of toxicity outcomes after proton therapy and intensity-modulated radiation therapy for prostate cancer. Fang, P., Mick, R., Deville, C., et al.[2022]

References

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

Case-Matched Outcomes of Proton Beam and Intensity-Modulated Radiation Therapy for Localized Prostate Cancer. [2023]

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

Can We Advance Proton Therapy for Prostate? Considering Alternative Beam Angles and Relative Biological Effectiveness Variations When Comparing Against Intensity Modulated Radiation Therapy. [2022]

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

Treatment planning comparison of IMPT, VMAT and 4π radiotherapy for prostate cases. [2022]

4. England pubmed.ncbi.nlm.nih.gov

LOW DOSE BATH FROM IMPT VS. IMXT FOR THE PELVIC AREA WHEN TREATING ADVANCED PROSTATE CANCER. [2020]

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

Radiotherapy treatment of early-stage prostate cancer with IMRT and protons: a treatment planning comparison. [2020]

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

Finding Value for Protons: The Case of Prostate Cancer? [2018]

7. 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]

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

Modeling of Acute Rectal Toxicity to Compare Two Patient Positioning Methods for Prostate Cancer Radiotherapy: Can Toxicity Modeling be Used for Quality Assurance? [2022]

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

A case-matched study of toxicity outcomes after proton therapy and intensity-modulated radiation therapy for prostate cancer. [2022]

10. Czech Republic pubmed.ncbi.nlm.nih.gov

[Five-year results of IMRT for prostate cancer - tumor control]. [2019]