Proton Therapy vs. IMRT for Prostate Cancer

(PARTIQoL Trial)

Recruiting at 13 trial locations

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Prior surgery, Metastases, Hip prosthesis, others

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

Compensation: Varies

Number of Visits: 5

454 Participants Needed

Trial Summary

What is the purpose of this trial?

We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams. IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and are thought to be equally effective at curing prostate cancer. However, both treatments have also been shown to cause the potential side effects of radiation, including bowel, urinary and erectile problems. It is possible that side effect rates with PBT will be lower, the same, or even higher than with IMRT, but this has not been studied well to date. Though both of these radiation therapies have been used in the past to treat prostate cancer, there has never been a study that compares the effects of these two therapies to see which one has less side effects. In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking Dutasteride or Finasteride, your PSA levels must meet certain criteria.

What data supports the effectiveness of the treatment Proton Therapy vs. IMRT for Prostate Cancer?

Both proton beam therapy (PBT) and intensity-modulated radiation therapy (IMRT) are effective for controlling prostate cancer, but PBT may reduce the dose to normal organs, potentially leading to less side effects. However, direct comparisons of their effectiveness and side effects are limited. ^{1 2 3 4 5}

Is proton therapy safe compared to IMRT for prostate cancer?

Research shows that proton therapy (PBT) and intensity-modulated radiation therapy (IMRT) for prostate cancer have been studied for safety, focusing on side effects like those affecting the stomach and urinary systems. Studies suggest that PBT may have a lower risk of these side effects compared to IMRT. ^{1 2 5 6 7}

How does proton therapy differ from IMRT for prostate cancer treatment?

Proton therapy (PBT) is unique because it can reduce the dose to normal organs compared to intensity-modulated radiation therapy (IMRT), potentially leading to less side effects in the gastrointestinal (GI) and genitourinary (GU) systems. ^{1 2 3 4 5}

Research Team

Jason A. Efstathiou

Principal Investigator

Massachusetts General Hospital

Justin Bekelman, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

Men with low or intermediate risk prostate cancer, specifically adenocarcinoma based on biopsy within the last year. Eligible participants have a PSA level <20, Gleason score ≤7, and are in good physical condition (ECOG 0-1). They must not have had prior treatments for prostate cancer or other cancers unless disease-free for 5 years or at low risk of recurrence.

Inclusion Criteria

I was diagnosed with prostate cancer from a biopsy within the last year.

I am taking or have recently taken Dutasteride or Finasteride, and my PSA is 10 or below.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

My cancer has spread to distant areas or lymph nodes, confirmed by a CT scan in the last year.

I do not have AIDS or untreated HIV.

I have had liver problems causing jaundice or blood clotting issues in the past year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive either IMRT or PBT radiation therapy once a day for 5 days a week for up to 9 weeks

9 weeks

Daily visits (in-person) for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months

60 months

Multiple visits (in-person) over 5 years

Long-term Follow-up

Assess longer-term rates of disease-specific and overall survival as well as development of late effects such as second cancers

10 years

Treatment Details

Interventions

• Intensity Modulated Radiation Therapy
• Proton Beam Therapy

Trial Overview The study is comparing two external radiation treatments for prostate cancer: Intensity Modulated Radiation Therapy (IMRT) and Proton Beam Therapy (PBT). Both aim to target the cancer while sparing surrounding tissue. The goal is to determine which therapy better minimizes side effects like bowel, urinary, and erectile problems.

Participant Groups

Group I: PBT Active Control 1 Intervention

Proton Beam Therapy

Group II: IMRT Active Control 1 Intervention

Intensity Modulated Radiation Therapy

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

Approved in United States as Intensity Modulated Radiation Therapy for:

• Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors

Approved in European Union as Intensity Modulated Radiation Therapy for:

• Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors

Approved in Canada as Intensity Modulated Radiation Therapy for:

• Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors

Approved in Japan as Intensity Modulated Radiation Therapy for:

• Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors

Approved in China as Intensity Modulated Radiation Therapy for:

• Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Northwestern Medicine Chicago Proton Center

Collaborator

Trials

1

Recruited

450+

University of Maryland Medical Center

Collaborator

Trials

4

Recruited

850+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

ProCure Proton Therapy Center

Collaborator

Trials

1

Recruited

450+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Provision Center for Proton Therapy

Collaborator

Trials

3

Recruited

990+

University of Florida Proton Therapy Institute

Collaborator

Trials

1

Recruited

450+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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 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]

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 of 1850 patients with early-stage prostate cancer, both moderately hypofractionated proton beam therapy (PBT) and intensity modulated radiation therapy (IMRT) resulted in low rates of late genitourinary (GU) and gastrointestinal (GI) toxicity, indicating that both treatments are safe options.

There was no significant difference in late toxicity rates between PBT and IMRT, with late grade 3+ GU toxicity at 2.0% for PBT and 3.9% for IMRT, and late grade 2+ GI toxicity at 14.6% for PBT and 4.7% for IMRT, suggesting both modalities are equally effective in minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pooled Toxicity Analysis of Moderately Hypofractionated Proton Beam Therapy and Intensity Modulated Radiation Therapy in Early-Stage Prostate Cancer Patients. Vapiwala, N., Wong, JK., Handorf, E., et al.[2022]

Proton-beam therapy (PBT) significantly reduced low-range doses to the bladder and rectum compared to intensity-modulated radiotherapy (IMRT) in patients treated post-prostatectomy, indicating a potential advantage in minimizing radiation exposure to surrounding tissues.

Despite the dosimetric benefits of PBT, there were no significant differences in acute or late genitourinary (GU) and gastrointestinal (GI) toxicities reported by clinicians between the two treatment modalities, suggesting that both therapies have similar safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative toxicity outcomes of proton-beam therapy versus intensity-modulated radiotherapy for prostate cancer in the postoperative setting. Santos, PMG., Barsky, AR., Hwang, WT., et al.[2020]

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

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

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

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

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

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

5. 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]

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

A Pooled Toxicity Analysis of Moderately Hypofractionated Proton Beam Therapy and Intensity Modulated Radiation Therapy in Early-Stage Prostate Cancer Patients. [2022]

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

Comparative toxicity outcomes of proton-beam therapy versus intensity-modulated radiotherapy for prostate cancer in the postoperative setting. [2020]