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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of radiation therapy to determine if a shorter treatment course can effectively manage prostate cancer that has returned or spread to nearby areas. Proton beam therapy aims to reduce side effects by delivering smaller doses over time, while IMRT (Intensity-Modulated Radiation Therapy) uses high-energy x-rays to target tumors. Men previously treated for prostate cancer but experiencing a recurrence limited to certain lymph nodes might find this trial relevant. Participants will undergo imaging tests and blood sample collection throughout the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both proton beam radiation therapy and intensity-modulated radiation therapy (IMRT) are well-tolerated treatments for prostate cancer.

For proton beam radiation therapy, studies have found it to be at least as effective as traditional radiation in treating cancer. No major differences in long-term cancer control or survival exist between proton therapy and other radiation methods, making proton therapy a safe option for treating prostate cancer.

IMRT also demonstrates good safety results. One study found no severe side effects with highly hypofractionated IMRT, which uses larger doses over fewer sessions. Long-term analysis revealed that moderate side effects affecting the urinary system occurred in about 17% to 33% of patients, indicating that IMRT is generally safe with manageable side effects.

Both treatments have been used in prostate cancer care, providing good cancer control and manageable side effects, making them viable options for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they offer cutting-edge advancements in radiation therapy. Proton beam radiation therapy stands out by using protons instead of traditional X-rays, which can deliver high doses of radiation more precisely to tumor sites, potentially reducing damage to surrounding healthy tissue. On the other hand, Intensity-Modulated Radiation Therapy (IMRT) uses advanced technology to modulate the radiation intensity, allowing for customized radiation doses that conform to the shape of the tumor. Both methods aim to improve treatment effectiveness and reduce side effects compared to standard radiation therapies.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare two treatments for prostate cancer: proton beam radiation therapy and intensity-modulated radiation therapy (IMRT). Studies have shown that proton beam radiation therapy effectively controls tumors and has few side effects, with survival rates for men with varying risk levels ranging from 76% to 99% five years after treatment. This therapy is expected to perform as well as traditional methods. Meanwhile, IMRT has also proven effective, with 89% of men remaining disease-free eight years after treatment. Long-term research indicates that IMRT has a 99% rate of controlling cancer locally and a 66% survival rate over ten years. Both treatments, tested in separate arms of this trial, offer promising results for managing prostate cancer. ^{2 5 6 7 8}

Who Is on the Research Team?

Brian J. Davis, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043750/

Intensity-modulated radiotherapy for prostate cancer - PMC Multiple clinical trials have demonstrated improved cancer outcomes with dose escalation, but toxicities using 3D-CRT and escalated doses have been problematic.

2. myrxtoolkit.com myrxtoolkit.com/web/public/brands/medicalpolicy/external-policies/intensity-modulated-radiotherapy-of-the-prostate/

Intensity-Modulated Radiotherapy of the Prostate Although there are few prospective comparative trials, the evidence has generally shown that IMRT provides tumor control and survival outcomes similar to 3- ...

3. nature.com nature.com/articles/s41391-022-00535-4

Prostate cancer intensity-modulated radiotherapy and long ... While the benefit of IMRT in reducing GU side effects compared to 3D-CRT techniques may be overall less evident than the expected benefit in ...

4. mskcc.org mskcc.org/news-releases/long-term-outcomes-prostate-show-intensity-modulated-radiation-therapy-curative-89-percent-men-disease-free-eight-years-l

Long-term Outcomes for Prostate Cancer Show Intensity ... Long-term Outcomes for Prostate Cancer Show Intensity Modulated Radiation Therapy Curative: 89 Percent of Men Disease-Free Eight Years Later.

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.921465/full

Long-term outcomes of prostate intensity-modulated ... The 10-year rates of local control, distant control, and survival were 99%, 88%, and 66%, respectively. Of 25 patients who died, only four (5%) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9399820/

Long-term outcomes of prostate intensity-modulated ... This retrospective study demonstrates the long-term outcomes of treating prostate cancer using intensity modulated (IMRT) with incorporation of MRI-directed ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1879850023001753

Long-Term Outcomes of a Prospective Study on Highly ... No grade ≥3 adverse events were observed, suggesting that highly hypofractionated IMRT is a safe treatment. Conventional fractionated radiation therapy at 1.8 ...

8. tau.amegroups.org tau.amegroups.org/article/view/17922/html

Intensity-modulated radiotherapy for prostate cancer Multiple clinical trials have demonstrated improved cancer outcomes with dose escalation, but toxicities using 3D-CRT and escalated doses have been problematic.