Proton Therapy vs. IMRT for Prostate Cancer

(PARTIQoL Trial)

Not currently recruiting at 14 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of radiation treatments for prostate cancer to determine which one has fewer side effects. One treatment uses x-ray beams (Intensity Modulated Radiation Therapy, or IMRT), while the other uses proton beams (Proton Beam Therapy, or PBT). Both aim to target the cancer while sparing healthy tissue, but it remains unclear which has fewer side effects, such as bowel, urinary, and erectile problems. Men diagnosed with certain stages of prostate cancer who have not undergone prior treatments like surgery or chemotherapy may be suitable for this study. As an unphased trial, this study allows patients to contribute to important research that could enhance future prostate cancer treatments.

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.

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

Research has shown that both Proton Beam Therapy (PBT) and Intensity Modulated Radiation Therapy (IMRT) are generally safe for treating prostate cancer, though side effects can occur.

For PBT, studies indicate it often controls cancer effectively with fewer severe side effects. At a 45-month follow-up, patients experienced manageable side effects. However, long-term data remains limited.

IMRT also maintains a good safety record. Research found that most patients tolerate it well, with only about 1% to 2.3% experiencing severe stomach, intestine, or urinary side effects over the long term.

Both treatments aim to limit radiation exposure to healthy tissues, reducing the risk of side effects. Nonetheless, issues with bowel, urinary, and erectile function can still arise.

Overall, both PBT and IMRT are considered safe, but individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Proton Beam Therapy (PBT) is unique because it targets prostate cancer cells with high precision, minimizing damage to surrounding healthy tissues. Unlike standard radiation treatments, PBT uses charged particles (protons) that stop at the tumor, potentially reducing side effects. Researchers are excited about this method because it could offer better quality of life during and after treatment. Meanwhile, Intensity Modulated Radiation Therapy (IMRT) allows for precise targeting, too, but uses X-rays instead. The excitement here lies in comparing these two advanced technologies to find out which one offers the best outcomes for prostate cancer patients.

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

This trial will compare Proton Beam Therapy (PBT) and Intensity Modulated Radiation Therapy (IMRT) for treating prostate cancer. Research has shown that both PBT and IMRT are effective for this condition. Studies have found that PBT achieves a high five-year survival rate, with 97% of men alive after treatment. Similarly, IMRT provides excellent long-term disease control, with a 99% success rate in preventing cancer recurrence over ten years. A study comparing PBT and IMRT found no major differences in survival between the two treatments. Both therapies effectively target the prostate while protecting nearby tissues. However, researchers continue to study the side effects to determine if one treatment causes fewer problems than the other. ^{1 6 7 8 9}

Who Is on the Research Team?

Jason A. Efstathiou

Principal Investigator

Massachusetts General Hospital

Justin Bekelman, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

Citations

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

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%) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2331518023000136

Case-Matched Outcomes of Proton Beam and Intensity ... Both PBT and IMRT offer excellent long-term disease control for PCa, with no significant differences between the 2 modalities in BFFS, PCSS, and OS in matched ...

3. academic.oup.com academic.oup.com/jrr/article/66/1/39/7954234

Real-world comparative outcomes and toxicities after ... This retrospective study aimed to compare the clinical outcomes of intensity-modulated radiation therapy (IMRT) and proton beam therapy (PBT). A ...

4. 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.

5. asco.org asco.org/abstracts-presentations/ABSTRACT89265

Comparative effectiveness of intensity modulated radiation ... Results: IMRT use increased from 0.15% in 2000 to 95.9% in 2008. In propensity score-adjusted analyses, men who received IMRT vs. CRT were less likely to be ...

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

Prostate cancer intensity-modulated radiotherapy and long ... The pooled 60-month cumulative incidence of RTOG and CTCAE Grade ≥2 genitourinary toxicity were 17% (95% CI: 5–20%, n = 678) and 33% (95% CI: 27 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40208274/

Intensity modulated radiation therapy in prostate cancer ... Overall survival rates for patients with a total radiation dose ≥ 76 Gy were 92% and 59% at 5 and 10 years, respectively, in comparison with ...

8. 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 ...

9. advancesradonc.com advancesradonc.com/article/S2452-1094(19)30042-9/fulltext

Dose-Escalated Intensity Modulated Radiation Therapy for ... Our findings indicate that it is well tolerated with 1.0% and 2.3% incidence of long-term grade 3+ GI and GU toxicity, respectively.