Bladder Management for Prostate Cancer Radiotherapy

Not currently recruiting at 6 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Urinary incontinence, Bladder metastases, Catheterization, 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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how bladder fullness affects radiation therapy for prostate cancer. Radiation therapy treats prostate cancer, and the trial aims to determine if bladder fullness alters the treatment experience or outcomes. Participants are divided into two groups: one with a full bladder during treatment and one with an empty bladder. Men diagnosed with prostate cancer, planning to undergo radiation therapy, and without severe urinary issues may qualify for this trial. As an unphased trial, it provides a unique opportunity to contribute to understanding the impact of bladder fullness on radiation therapy 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 prior data suggests that this protocol is safe for prostate cancer patients?

Research has shown that radiation therapy is generally safe for prostate cancer patients, even when the bladder is emptied before treatment. Studies have found that traditional radiation treatments rarely cause severe side effects. In some studies, no serious side effects were reported, indicating that patients tolerate the treatment well.

Intensity-modulated radiotherapy, a common type of radiation for prostate cancer, has been used safely for many years. While some patients might experience mild side effects, the chance of serious problems remains low. This evidence supports the manageability of radiation therapy for most patients, regardless of bladder fullness during treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different bladder management techniques during prostate cancer radiotherapy to potentially improve treatment outcomes. Traditional radiotherapy for prostate cancer often involves either filling or emptying the bladder to stabilize prostate positioning, but there's uncertainty about which method optimally enhances the effectiveness of radiation. This trial compares the effect of bladder filling versus bladder emptying on the precision and impact of radiotherapy. By determining the best approach, clinicians hope to maximize the effectiveness of radiation treatment, reduce side effects, and improve the overall quality of life for patients.

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

Research has shown that having a full bladder before prostate cancer radiation therapy can help target the radiation more precisely to the prostate and protect nearby organs. One study found that maintaining a full bladder during treatment reduces radiation exposure to the bladder and bowel, potentially decreasing side effects. In this trial, participants in Arm I will follow this bladder-filling approach. However, patients who struggle to keep their bladder full due to urinary issues might benefit from an empty bladder approach, which is under study in Arm II. This method can also make treatment sessions less stressful and quicker. Both approaches in this trial aim to enhance the effectiveness of radiation by managing bladder size during therapy. ^{6 7 8 9 10}

Who Is on the Research Team?

Bradley J. Stish, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography
• 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.

How Is the Trial Designed?

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 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?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

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 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]

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]

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 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 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]

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]

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06037863

Evaluation of the Impact of Empty Versus Full Bladder in ... 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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1078817425001609

Comparison with cone-beam computed tomography (CBCT) Prostate cancer radiotherapy requires consistent bladder filling to optimize dose delivery and minimize toxicity. This prospective study evaluated the accuracy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3473792/

Assessing the daily consistency of bladder filling using an ... This study evaluates the effectiveness of bladder-filling instructions in achieving a consistent and reproducible bladder volume at the time of planning CT and ...

4. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-020-01681-6

Strict bladder filling and rectal emptying during prostate SBRT The average bladder volume reduction per patient from Sim-CT to fraction #5 (V5-SimBladder) significantly decreased by 86.9 mL or 19.0% ( ...

5. redjournal.org redjournal.org/article/S0360-3016(25)03425-X/fulltext

Handheld Bladder Scanners, Treatment Efficiency and ... Augmenting our full bladder protocol for prostate cancer with a handheld bladder scanner resulted in a significant decrease in excess CBCTs. This improved ...

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

Long-term outcomes of prostate intensity-modulated ... palliative radiation provides significantly improved overall survival at 5 years (42.3% vs. 17.7%, p = 0.006) (41). The STAMPEDE trial evaluated ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214122

Fifteen-Year Outcomes after Monitoring, Surgery, or ... After median follow-up of 15 years, 45 patients (2.7%) had died of prostate cancer: 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the ...

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

Prostate cancer intensity-modulated radiotherapy and long ... Prostate cancer intensity-modulated radiotherapy and long term genitourinary toxicity: an evolving therapeutic landscape

9. 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 ...

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

Intensity-modulated radiotherapy for prostate cancer They identified that dose-escalated radiation resulted in significant reductions in biochemical failure, but there were no differences in the rate of all-cause ...