Intensity Modulated Radiation Therapy for Prostate Cancer

(SIB Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how new radiation technologies can precisely target prostate cancer, potentially improving outcomes and reducing side effects. The focus is on Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT), which deliver high doses of radiation directly to cancer cells while sparing healthy tissue. Men with confirmed prostate cancer, who haven't had prior radiation or chemotherapy and meet specific criteria regarding tumor risks, might be suitable candidates. Participants will receive targeted radiation to both the prostate and nearby lymph nodes to assess the benefits and any drawbacks of this treatment. As an unphased trial, this study offers participants the opportunity to contribute to cutting-edge research that could shape future prostate cancer treatments.

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 prior data suggests that Intensity Modulated Radiation Therapy and Image Guided Radiation Therapy are safe for prostate cancer treatment?

Research has shown that Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT) are generally manageable for patients with prostate cancer. Studies have found that IMRT delivers radiation more precisely than older methods, resulting in fewer side effects. Specifically, patients experienced less harm to nearby healthy tissues, leading to fewer urinary and bowel issues.

Another study found that IGRT helps control tumor growth while reducing side effects related to the stomach and urinary system. IGRT allows doctors to aim the radiation more accurately, protecting nearby healthy tissues.

Overall, past research has demonstrated the safety of these newer radiation technologies. Most patients tolerated the treatments well, with fewer reports of severe side effects compared to traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intensity Modulated Radiation Therapy (IMRT) with Image-Guided Radiation Therapy (IGRT) for prostate cancer because it allows for precise targeting of high doses of radiation. Unlike standard radiation treatments, which may affect surrounding healthy tissues, IMRT and IGRT focus the radiation more accurately on the prostate and pelvic lymph nodes, minimizing damage to other areas. This precise delivery could potentially improve outcomes and reduce side effects, making it a promising approach for patients with prostate cancer.

What evidence suggests that Intensity Modulated Radiation Therapy is effective for prostate cancer?

Research has shown that Intensity Modulated Radiation Therapy (IMRT), which participants in this trial will receive, effectively treats prostate cancer that hasn't spread. Studies indicate that about 90% of patients do not experience a recurrence within five years. IMRT delivers precise radiation doses, resulting in fewer side effects compared to older treatments. In this trial, Image Guided Radiation Therapy (IGRT) accompanies IMRT to better target the tumor, potentially improving outcomes. No serious side effects have been reported, making these treatments both effective and safe for patients. ^{1 3 4 6 7}

Who Is on the Research Team?

William A. Hall

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. 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 ...

2. 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 ...

3. 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 ...

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

Real-world comparative outcomes and toxicities after ... IMRT is a standard treatment for localized prostate cancer with a 5-year bRFS of approximately 90% [13, 17–19]. In this study, there was a ...

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

Intensity-modulated radiotherapy for prostate cancer IMRT is a method to deliver dose escalated RT with more conformal dose distributions than 3D-CRT and has been associated with improved toxicity profiles.

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

Intensity-modulated radiotherapy for prostate cancer - PMC IMRT is a method to deliver dose escalated RT with more conformal dose distributions than 3D-CRT and has been associated with improved toxicity profiles.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405630822001008

The role of image-guided radiotherapy in prostate cancer IGRT was associated with an improvement in biochemical tumor control and a reduction in GI and acute GU toxicity, but did not significantly improve 5-year OS ...