Intensity Modulated Radiation Therapy for Prostate Cancer

(SIB Trial)

Recruiting at 1 trial location

Overseen By Colleen A. Lawton

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Metastases, Radical surgery, Chemotherapy, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does allow for induction hormonal therapy before joining the study.

What data supports the effectiveness of Intensity Modulated Radiation Therapy (IMRT) for prostate cancer treatment?

Research shows that Intensity Modulated Radiation Therapy (IMRT) for prostate cancer can deliver higher radiation doses with lower toxicity, improving tumor control and potentially increasing disease-free survival rates. IMRT combined with Image-Guided Radiotherapy (IGRT) is recommended for high-dose treatments, and it shows promising results in increasing locoregional control while limiting side effects. ^{1 2 3 4 5}

Is Intensity Modulated Radiation Therapy (IMRT) generally safe for humans?

Research shows that Intensity Modulated Radiation Therapy (IMRT) is generally safe for treating prostate cancer, with reduced side effects compared to older methods. Studies have found that IMRT, especially when combined with image guidance, results in fewer acute and late toxicities, particularly in the gastrointestinal and genitourinary systems. ^{6 7 8 9 10}

How is intensity-modulated radiation therapy (IMRT) different from other treatments for prostate cancer?

Intensity-modulated radiation therapy (IMRT) is unique because it uses advanced computer technology to deliver higher doses of radiation directly to the prostate while minimizing exposure to surrounding healthy tissues, potentially reducing side effects like gastrointestinal and urinary issues. ^{11 12 13 14 15}

Research Team

William A. Hall

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for men with prostate cancer that hasn't spread to other parts of the body. They must have a specific Gleason score, which measures cancer aggressiveness, and no history of chemotherapy or radiation in the pelvic area. Participants need to be able to perform daily activities without significant assistance (Karnofsky Performance Scale > 70).

Inclusion Criteria

My prostate cancer is at an early stage but has a high risk of spreading, or it's more advanced but hasn't spread to other parts.

I haven't had radiation or chemotherapy for my pelvic or prostate area, but I may have had hormone therapy.

I am able to care for myself and perform normal activities with minimal assistance.

Exclusion Criteria

I have had radiation therapy in the pelvic area before.

My cancer has spread to distant parts of my body.

I have had chemotherapy in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

High-dose radiation delivered to pelvic lymph nodes and prostate using IMRT and IGRT

8-10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

55 months

Treatment Details

Interventions

• Radiation Therapy

Trial Overview The study tests high-dose radiation therapy targeting lymph nodes using advanced technologies called Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT), aiming for precise delivery to improve treatment outcomes.

Participant Groups

Group I: IMRT & IGRT Radiation Therapy Experimental Treatment 1 Intervention

In this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).

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

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Findings from Research

Radiotherapy is as effective as radical prostatectomy for localized prostate cancer when administered at sufficient doses, with various modalities like interstitial brachytherapy and external beam radiotherapy available.

Advancements such as intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) allow for higher radiation doses while reducing toxicity, and combining radiotherapy with hormonal ablation enhances local control rates in specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiotherapy in prostate cancer]. Ganswindt, U., Belka, C.[2021]

In a study of 285 patients treated with salvage radiation therapy (SRT) after prostate surgery, intensity-modulated radiation therapy (IMRT) significantly reduced the risk of late grade ≥2 gastrointestinal (GI) toxicity compared to three-dimensional conformal radiation therapy (3D-CRT), with rates of 1.9% for IMRT versus 10.2% for 3D-CRT.

While IMRT showed benefits in reducing GI toxicity, it did not significantly lower the risk of late grade ≥2 genitourinary (GU) toxicity or other complications like urinary incontinence and erectile dysfunction when compared to 3D-CRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved toxicity profile following high-dose postprostatectomy salvage radiation therapy with intensity-modulated radiation therapy. Goenka, A., Magsanoc, JM., Pei, X., et al.[2022]

Intensity-modulated radiation therapy (IMRT) significantly reduces the mean dose and volume of radiation received by the rectum and bladder compared to 3-dimensional conformal radiation therapy (3DCRT), which is crucial for minimizing side effects in prostate cancer treatment.

IMRT allows for dose escalation up to 72.0 Gy while maintaining similar safety profiles for the bladder and rectum compared to 3DCRT at 68.4 Gy, suggesting potential for improved treatment efficacy without increasing toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential for dose escalation in the postprostatectomy setting with intensity-modulated radiation therapy: a dosimetric study using EORTC consensus guidelines for target volume contours. Harrison, A., Studenski, M., Harvey, A., et al.[2016]

Prostate cancer treatment has advanced significantly from traditional 2D radiotherapy to more precise methods like intensity-modulated radiation therapy (IMRT) and stereotactic radiotherapy, enhancing treatment efficacy and reducing side effects.

Emerging techniques such as proton therapy and carbon therapy are being explored to further improve treatment outcomes, shorten treatment times, and minimize toxicity and costs for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What is the level of evidence of new techniques in prostate cancer radiotherapy?]. Khadige, M., Peiffert, D., Supiot, S.[2018]

Intensity-modulated radiotherapy (IMRT) combined with image-guided radiotherapy (IGRT) is recommended for high-dose treatments (≥76Gy) in prostate cancer, as it allows for effective dose escalation while managing toxicity.

Stereotactic body radiotherapy shows promise for prostate cancer treatment, but more extensive follow-up and phase III trials are needed to establish its efficacy and safety compared to established techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prostate cancer: what treatment techniques for which tumors? Ethical and methodological issues]. de Crevoisier, R., Castelli, J., Guérif, S., et al.[2018]

Intensity-modulated radiation therapy (IMRT) resulted in significantly lower rates of acute and late genitourinary (GU) and gastrointestinal (GI) toxicity compared to (125)I seed implants, with 3-year rates of 3.5% GU and 2.4% GI toxicity for IMRT versus 19.2% GU and 7.7% GI for (125)I.

Both treatments showed similar biochemical failure rates, with IMRT having a 4-year freedom from failure rate of 99.5% compared to 93.5% for (125)I, indicating that while both are effective, IMRT may be safer with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or (125)I permanent implant. Eade, TN., Horwitz, EM., Ruth, K., et al.[2022]

In a study of 192 patients with localized prostate cancer, using prostate-based IGRT (P-IGRT) resulted in significantly lower acute gastrointestinal toxicities compared to bony structure-based IGRT (B-IGRT), with rates of 3% versus 11%.

Both P-IGRT and B-IGRT showed similar prostate-specific antigen failure-free survival rates at 3 years (95.5% for P-IGRT and 92.7% for B-IGRT), indicating that P-IGRT can reduce toxicity without compromising tumor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. Nakamura, K., Mizowaki, T., Inokuchi, H., et al.[2018]

In a study of 421 patients undergoing salvage radiotherapy (SRT) after prostate surgery, the use of advanced techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) significantly reduced the incidence of late gastrointestinal (GI) toxicities to 4.8%.

However, increasing the radiation dose to 68 Gy or more was linked to a higher risk of genitourinary (GU) toxicities, indicating that while advanced techniques can help minimize some side effects, higher doses may still pose risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. Tomita, N., Uchiyama, K., Mizuno, T., et al.[2021]

Patients with high-risk prostate cancer treated with image-guided intensity-modulated radiotherapy (IG-IMRT) experienced significantly lower rates of gastrointestinal (GI) toxicity (5.8%) compared to those treated with 3D conformal radiotherapy (3DCRT) (57.3%), indicating that IG-IMRT is a safer option.

Both IG-IMRT and 3DCRT showed similar rates of biochemical progression-free survival at 3 years (90.3% for IG-IMRT vs. 86.0% for 3DCRT), suggesting that while IG-IMRT reduces toxicity, it does not compromise treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance. Sveistrup, J., af Rosenschöld, PM., Deasy, JO., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Radiotherapy in prostate cancer]. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Improved toxicity profile following high-dose postprostatectomy salvage radiation therapy with intensity-modulated radiation therapy. [2022]

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

Potential for dose escalation in the postprostatectomy setting with intensity-modulated radiation therapy: a dosimetric study using EORTC consensus guidelines for target volume contours. [2016]

4. France pubmed.ncbi.nlm.nih.gov

[What is the level of evidence of new techniques in prostate cancer radiotherapy?]. [2018]

5. France pubmed.ncbi.nlm.nih.gov

[Prostate cancer: what treatment techniques for which tumors? Ethical and methodological issues]. [2018]

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

A comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or (125)I permanent implant. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]

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

Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Percutaneous radiotherapy for low-risk prostate cancer: options for 2007. [2018]

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

High-dose intensity modulated radiation therapy for prostate cancer. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of external-beam radiation approaches for prostate cancer. [2022]

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

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

14. England pubmed.ncbi.nlm.nih.gov

Clinical use of intensity-modulated radiotherapy: part II. [2005]

15. Germany pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy (IMRT) of localized prostate cancer: a review and future perspectives. [2015]