Bladder Management for Prostate Cancer Radiotherapy

Recruiting at6 trial locations

Overseen by Bradley J. Stish, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Urinary incontinence, Bladder metastases, Catheterization, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates the effects of an empty bladder versus (vs.) a full bladder prior to undergoing a computed tomography (CT) simulation for radiation therapy in patients with prostate cancer. Radiation therapy is a commonly used treatment for men diagnosed with prostate cancer. Prior to initiation of a course of radiotherapy, all patients with prostate cancer undergo a CT simulation that allows for computer-based optimization of radiation dose delivery to the target tissue (i.e., prostate) and simultaneous dose minimization to surrounding normal tissues, such as bladder and rectum. Patients are typically given standard instructions for preparation to present with a reproducible full bladder at the time of CT simulation and for each subsequent radiation treatment appointment. The goal of bladder distension is to displace portions of the bladder and bowel away from the highest dose radiation delivery to the prostate. However, as typical urinary symptoms related to radiotherapy develop during treatment, some patients are unable to reproduce the bladder distention achieved at the time of CT simulation. This can result in increased daily treatment time, sub-optimal reproducibility of patient internal anatomy, and increased stress for patients and radiation therapy staff. This trial will evaluate the effects of an empty bladder vs. a full bladder prior to CT simulation and radiation therapy in patients with prostate cancer and how it effects patient reported outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for prostate cancer radiotherapy?

Research shows that intensity-modulated radiation therapy (IMRT) can improve outcomes for prostate cancer patients by allowing higher doses of radiation to be delivered more precisely, reducing side effects and improving tumor control. Additionally, image-guided radiotherapy (IGRT) and stereotactic body radiotherapy (SBRT) are advanced techniques that enhance the accuracy and effectiveness of treatment, potentially leading to better long-term results. ^{1 2 3 4 5}

Is radiotherapy generally safe for humans?

Radiotherapy techniques like intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT) have been studied for prostate cancer, showing some risk of side effects such as urinary and gastrointestinal issues, but these are generally manageable. Advanced techniques like IMRT and IGRT can reduce the risk of these side effects compared to older methods. ^{6 7 8 9 10}

How is the treatment 'Radiation Therapy' for prostate cancer different from other treatments?

Radiation therapy for prostate cancer, including advanced techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT), allows for precise targeting of the cancer with high doses of radiation while minimizing damage to surrounding healthy tissue. This approach can be as effective as surgery and is particularly beneficial for patients who cannot undergo surgery, offering improved local control and potentially better quality of life. ^{4 11 12 13 14}

Research Team

Bradley J. Stish, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

Men over 18 with prostate cancer who can consent, have an ECOG performance status of 0-2, and can fill out questionnaires. They should be set for radiotherapy but not have significant urinary incontinence, bladder metastases, use catheters, need pelvic lymph node radiation or brachytherapy, or had prior pelvic radiotherapy above 5 Gy.

Inclusion Criteria

I am scheduled for targeted radiation therapy to my prostate.

Ability to complete questionnaire(s) by themselves or with assistance

Provide written informed consent

Exclusion Criteria

I am scheduled for radiation therapy targeting my pelvic lymph nodes.

I have severe urinary incontinence that prevents normal bladder filling.

My prostate cancer has spread to my bladder.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CT Simulation

Participants undergo a CT simulation to optimize radiation dose delivery

1 week

1 visit (in-person)

Radiation Therapy

Participants receive radiation therapy with either a full or empty bladder in 2-39 fractions

4-8 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

Treatment Details

Interventions

• Computed Tomography (Procedure)
• Radiation Therapy (Radiation Therapy)

Trial Overview The RELIEF trial is testing whether having an empty or full bladder during CT simulation affects the treatment experience for prostate cancer patients receiving radiation therapy. It looks at how this impacts patient comfort and the precision of targeting the tumor while sparing normal tissues.

Participant Groups

Group I: Arm II (bladder emptying, CT, radiation) Experimental Treatment 5 Interventions

Patients perform bladder emptying and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.

Group II: Arm I (bladder filling, CT, radiation) Active Control 5 Interventions

Patients perform SOC bladder filling and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.

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

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?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Findings from Research

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]

Radiotherapy can be an effective curative treatment for prostate cancer, especially when patient selection is done carefully to maximize benefits.

Dose-escalated radiation and advanced imaging technologies have improved patient outcomes, and there is renewed interest in hypofractionated radiotherapy methods like stereotactic body radiotherapy and brachytherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary issues in radiotherapy for clinically localized prostate cancer. Khor, R., Williams, S.[2013]

Radiation therapy is an effective treatment for localized prostate cancer, but there is still a significant rate of cancer persistence after treatment, indicating a need for improved methods.

New radiation techniques are being developed to enhance local control of the cancer while also aiming to preserve bladder and sexual function, and ongoing research seeks to identify which patients will benefit most from radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of radiotherapy in locally limited prostate cancer]. Herr, HW.[2006]

In a study of 58 patients receiving high-dose radiation therapy for prostate cancer, using gold markers for image-guided radiation therapy (IGRT) reduced residual positioning errors, particularly in the vertical direction.

Despite the reduction in positioning errors with gold markers, the overall differences in dose distributions were moderate, suggesting that daily megavoltage CT (MVCT) alone could be a sufficient and valid alternative for IGRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric implications of inter- and intrafractional prostate positioning errors during tomotherapy : Comparison of gold marker-based registrations with native MVCT. Wust, P., Joswig, M., Graf, R., et al.[2022]

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]

In a study of 156 patients with localized prostate cancer, three-dimensional conformal radiation therapy resulted in significantly higher rates of grade 1 or 2 urinary toxicities compared to intensity-modulated radiation therapy and high-dose-rate brachytherapy, indicating a potential safety concern with this treatment method.

Gastrointestinal toxicities were also more frequent with three-dimensional conformal radiation therapy, while high-dose-rate brachytherapy showed no grade 1 or 2 gastrointestinal toxicities, suggesting that brachytherapy techniques may be safer options for minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of acute and subacute genitourinary and gastrointestinal adverse events of radiotherapy for prostate cancer using intensity-modulated radiation therapy, three-dimensional conformal radiation therapy, permanent implant brachytherapy and high-dose-rate brachytherapy. Morimoto, M., Yoshioka, Y., Konishi, K., et al.[2017]

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 100 prostate cancer patients treated with high-dose intensity-modulated radiotherapy (IMRT) and image-guided treatment (IGRT), acute gastrointestinal (GI) toxicity was observed in 12% and genitourinary (GU) toxicity in 42%, with only 4% experiencing severe GU toxicity (grade 3).

After a median follow-up of 26 months, late toxicity rates were low, with only 1.5% experiencing late GI toxicity and 7.7% experiencing late GU toxicity, indicating that high-dose radiotherapy is both effective and has manageable safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity after intensity-modulated, image-guided radiotherapy for prostate cancer. Guckenberger, M., Ok, S., Polat, B., et al.[2022]

In a study of 23 patients with high-risk prostate cancer, stereotactic body radiation therapy (SBRT) was found to be feasible and well tolerated, with low rates of severe gastrointestinal (GI) and genitourinary (GU) toxicities.

The treatment resulted in acute grade 1 GI toxicities in only 9.1% of patients and grade 3 GU toxicities in 4.5%, indicating that serious side effects were uncommon, but further long-term follow-up is needed to assess ongoing safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Tolerance Outcomes of Stereotactic Hypofractionated Accelerated Radiation Therapy Concomitant with Pelvic Node Irradiation in High-risk Prostate Cancer. Pinitpatcharalert, A., Happersett, L., Kollmeier, M., et al.[2022]

Recent advancements in radiation therapy techniques, such as stereotactic and intensity-modulated radiotherapy, allow for effective pelvic irradiation in metastatic bladder and prostate cancers with minimal major side effects.

Emerging data suggest that these advanced radiation therapies can improve quality of life, local control of the disease, and overall survival, although treatment decisions should be personalized for each patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[When is a nonsurgical approach possible for metastatic primary tumors and lymph node metastases of the urinary bladder and prostate?] Fietkau, R.[2018]

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]

The study involved 18 patients with muscle-invasive bladder cancer who had fiducial markers placed to improve targeting during radiotherapy, achieving a 98% retention rate of the markers throughout treatment without any complications.

Using micro-tined fiducial markers significantly improved targeting accuracy, resulting in a 2 to 6-fold reduction in the area of the bladder receiving high-dose radiation, which may enhance treatment efficacy and reduce side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic gold fiducial marker placement into the bladder wall to optimize radiotherapy targeting for bladder-preserving management of muscle-invasive bladder cancer: feasibility and initial outcomes. Garcia, MM., Gottschalk, AR., Brajtbord, J., et al.[2021]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. 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]

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

Contemporary issues in radiotherapy for clinically localized prostate cancer. [2013]

4. Germany pubmed.ncbi.nlm.nih.gov

[The role of radiotherapy in locally limited prostate cancer]. [2006]

5. Germany pubmed.ncbi.nlm.nih.gov

Dosimetric implications of inter- and intrafractional prostate positioning errors during tomotherapy : Comparison of gold marker-based registrations with native MVCT. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Comparison of acute and subacute genitourinary and gastrointestinal adverse events of radiotherapy for prostate cancer using intensity-modulated radiation therapy, three-dimensional conformal radiation therapy, permanent implant brachytherapy and high-dose-rate brachytherapy. [2017]

8. 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]

9. Germany pubmed.ncbi.nlm.nih.gov

Toxicity after intensity-modulated, image-guided radiotherapy for prostate cancer. [2022]

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

Early Tolerance Outcomes of Stereotactic Hypofractionated Accelerated Radiation Therapy Concomitant with Pelvic Node Irradiation in High-risk Prostate Cancer. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[When is a nonsurgical approach possible for metastatic primary tumors and lymph node metastases of the urinary bladder and prostate?] [2018]

12. Germany pubmed.ncbi.nlm.nih.gov

[Radiotherapy in prostate cancer]. [2021]

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

Endoscopic gold fiducial marker placement into the bladder wall to optimize radiotherapy targeting for bladder-preserving management of muscle-invasive bladder cancer: feasibility and initial outcomes. [2021]

14. France pubmed.ncbi.nlm.nih.gov

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