Radiotherapy Techniques for Prostate Cancer

Overseen By Sandy Chang

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Scott Tyldesley

Disqualifiers: Indwelling catheter, Hip prosthesis, Metastatic disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 20

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the side effects of two types of radiation therapy for prostate cancer: adaptive radiotherapy, which adjusts to changes in the body, and non-adaptive radiotherapy, which does not. It also examines whether personalized bladder-filling instructions can improve treatment outcomes. Men with prostate cancer that hasn't spread and who can follow bladder-filling instructions may be suitable for this study. The trial includes several groups testing different combinations of these treatments and instructions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in prostate cancer therapy.

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 these radiotherapy techniques are safe for prostate cancer treatment?

Past studies have shown that adaptive radiotherapy carries a low risk of serious side effects. Research suggests it causes fewer short-term side effects, particularly for prostate cancer, and might reduce stomach and bowel issues, making it potentially gentler on the body compared to some traditional treatments.

Specific recent safety data for non-adaptive radiotherapy isn't readily available, but it remains a well-known method frequently used in radiation therapy. Generally, treatments in Phase 2 trials are considered to have a basic safety profile, having already passed initial safety checks in earlier studies.

Researchers are studying both adaptive and non-adaptive radiotherapy to determine which one has fewer side effects. By participating in such a study, participants help researchers identify which method might be safer and more effective for future patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these radiotherapy techniques for prostate cancer because they explore the potential benefits of adaptive radiotherapy (RT) compared to non-adaptive RT. Adaptive RT is unique because it customizes the treatment plan based on real-time changes in the patient's anatomy, which could lead to more precise targeting of cancer cells while sparing healthy tissue. This contrasts with standard treatments that often rely on fixed plans. Additionally, by experimenting with custom bladder filling instructions, the trial aims to improve the effectiveness and reduce side effects of these radiotherapy techniques. These innovations could enhance treatment outcomes and patient quality of life.

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

This trial will compare adaptive radiotherapy with non-adaptive radiotherapy for prostate cancer. Studies have shown that adaptive radiotherapy, which adjusts to changes in the prostate's position during treatment, can make radiation delivery more accurate. This technique improves patient experiences by reducing urinary symptoms. Research indicates that adaptive radiotherapy better targets the prostate while reducing radiation exposure to nearby areas like the rectum. These improvements suggest it could be a more effective and safer treatment option for prostate cancer compared to methods that don't adjust during treatment.

Non-adaptive radiotherapy, another treatment option in this trial, remains effective but doesn't change to account for shifts in the prostate's position during treatment. This can lead to larger margins of error, potentially affecting nearby healthy tissues. Adaptive radiotherapy aims to address this by fine-tuning the treatment in real-time. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with intermediate or high risk localized prostate cancer. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have no conditions that could interfere with the study.

Inclusion Criteria

Willing and able to have regular per protocol follow up and blood work

Nodal risk ≥ 20% using the Memorial Sloan Kettering Nodal Risk Nomogram

Able to complete BC Cancer POSI questionnaires

Exclusion Criteria

Any other serious intercurrent illness or medical condition judged by the local investigator to compromise the participant's safety, preclude safe administration of the planned protocol treatment, or prevent the participant from being managed according to the protocol guidelines

I use more than one soaked pad or two dry pads daily due to urinary incontinence.

I have had radiation therapy to my pelvic area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive either adaptive or non-adaptive radiotherapy with standard or custom bladder filling instructions

4 weeks

20 fractions

Follow-up

Participants are monitored for safety and effectiveness after treatment using patient-reported and physician-reported questionnaires

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Radiotherapy
• Non-adaptive Radiotherapy

Trial Overview The study compares side effects of two radiation techniques: standard non-adaptive therapy versus daily adaptive therapy. It also examines if customized bladder filling instructions improve treatment outcomes for prostate cancer patients.

How Is the Trial Designed?

Group I: Arm 1i Active Control 1 Intervention

Adaptive RT \& Standard Bladder Filling Instructions

Group II: Arm 1ii Active Control 1 Intervention

Adaptive RT and Custom Bladder Filling Instructions

Group III: Arm 2i Active Control 1 Intervention

Non Adaptive RT and Standard Bladder Filling Instructions

Group IV: Arm 2ii Active Control 1 Intervention

Non Adaptive RT and Custom Bladder Filling Instructions

Adaptive Radiotherapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Trodelvy for:

• Metastatic triple-negative breast cancer (mTNBC)
• Metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer
• Metastatic urothelial cancer (approval being withdrawn)

Approved in European Union as Trodelvy for:

• Metastatic triple-negative breast cancer (mTNBC)
• Metastatic urothelial cancer

Approved in Canada as Trodelvy for:

• Metastatic triple-negative breast cancer (mTNBC)
• Metastatic urothelial cancer

Who Is Running the Clinical Trial?

Scott Tyldesley

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

Sacituzumab govitecan (SG) is an FDA-approved antibody-drug conjugate that has shown significant efficacy in treating metastatic triple-negative breast cancer, improving health-related quality of life and prolonging progression-free and overall survival in patients who have undergone multiple prior therapies.

Ongoing clinical trials are exploring the potential of SG for broader applications, including neoadjuvant and adjuvant therapies, combinations with immunotherapy, and treatment of various solid tumors, indicating its promise as a versatile cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of sacituzumab govitecan in solid tumors. Veeraballi, S., Khawar, Z., Aslam, HM., et al.[2023]

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]

The RTOG 3505 study is investigating the effectiveness of combining concurrent chemoradiation with the immune checkpoint inhibitor nivolumab in patients with locally advanced non-small-cell lung cancer, aiming to improve overall survival and progression-free survival.

With a planned enrollment of 660 patients, the study is designed to have sufficient power to detect significant differences in survival outcomes, ensuring robust results regarding the efficacy of nivolumab compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Design and Rationale for a Randomized Trial of Cisplatin and Etoposide Plus Thoracic Radiotherapy Followed by Nivolumab or Placebo for Locally Advanced Non-Small-Cell Lung Cancer (RTOG 3505). Gerber, DE., Urbanic, JJ., Langer, C., et al.[2018]

Sacituzumab govitecan (IMMU-132) demonstrated a predictable pharmacokinetic profile and manageable toxicity in patients with advanced epithelial cancers, with doses of 8 mg/kg (n=81) and 10 mg/kg (n=97) showing safety and efficacy.

The treatment resulted in objective responses in various cancer types, particularly metastatic triple-negative breast cancer, supporting the use of the 10 mg/kg dose for future clinical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. Ocean, AJ., Starodub, AN., Bardia, A., et al.[2018]

In a study of 50 patients with metastatic small cell lung cancer (mSCLC) who had been heavily pretreated, sacituzumab govitecan demonstrated a 14% objective response rate, with 60% of patients showing tumor shrinkage, indicating its potential efficacy as a treatment option.

The treatment was found to be generally safe, with manageable side effects; however, significant adverse events included neutropenia (34%) and fatigue (13%). This suggests that while effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. Gray, JE., Heist, RS., Starodub, AN., et al.[2022]

Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and delivers a topoisomerase I inhibitor, showing promise in treating metastatic triple-negative breast cancer (mTNBC) after at least two prior therapies.

In April 2020, it received accelerated approval in the USA for mTNBC, and it is currently undergoing further clinical trials for various cancers, indicating its potential as a versatile treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan: First Approval. Syed, YY.[2021]

Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2, showed promising therapeutic activity in a phase I trial with 25 patients suffering from various metastatic solid cancers, achieving partial responses in two patients and stable disease in 16 others.

The maximum tolerated dose was determined to be 12 mg/kg for the first cycle, with lower doses (8 and 10 mg/kg) being safer for extended treatment, leading to acceptable toxicity levels and disease control for up to 36 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Starodub, AN., Ocean, AJ., Shah, MA., et al.[2022]

Daily adaptive radiation therapy (ART) for non-small cell lung cancer (NSCLC) can effectively reduce lung exposure while maintaining adequate coverage of the tumor target volume, as shown in a study involving 13 patients and various treatment planning scenarios.

The study found that ART allows for dose escalation to the tumor without increasing the risk of damage to surrounding healthy tissues, suggesting a potential for improved local tumor control while minimizing toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric benefits of adaptive radiation therapy for patients with stage III non-small cell lung cancer. Hoppen, L., Sarria, GR., Kwok, CS., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2405630823001180

CT-based online adaptive radiotherapy improves target ... CT-based online adaptive SBRT resulted in statistically significant and clinically meaningful improvements in PTV coverage and D0.03 cc dose to the rectum.

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Evolution of Image Guidance and Adaptive Radiation ... This review details these advancements, highlighting their impact on local control, patient outcomes, and future implications for RT in prostate cancer ...

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First-in-Men Online Adaptive Robotic Stereotactic Body ... Dose-fractionation sensitivity of prostate cancer deduced from radiotherapy outcomes of 5,969 patients in seven international institutional datasets: α/β ...

4. ir.elekta.com ir.elekta.com/investors/press-releases/2025/study-shows-mri-guided-adaptive-radiotherapy-with-elekta-unity-improves-patient-reported-urinary-symptoms-in-men-with-prostate-cancer/

Study shows MRI-guided adaptive radiotherapy with ... The findings highlight the system's ability to visualize complex changes in prostate anatomy during therapy. This enables clinicians to create ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3664920/

Adaptive Radiation Therapy for Prostate Cancer - PMC Early studies have demonstrated that this technique could significantly improve the therapeutic ratio by safely reducing the large target margin that has to be ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818117

Safety and Tolerability of Online Adaptive High-Field ... The findings of this study suggest that online adaptive MR-guided radiotherapy is associated with a low risk of high-grade acute toxic effects.

7. physicianresources.foxchase.org physicianresources.foxchase.org/news/adaptive-radiation-therapy-increases-safety-and-preserves-quality-of-life-says-study

Adaptive Radiation Therapy Increases Safety and ... Researchers found that using CT adaptive stereotactic body radiation therapy (CTA-SBRT) can make repeat radiation not only possible, but safe.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814025052119

CT online adaptive radiotherapy is associated with ... Original Article. CT online adaptive radiotherapy is associated with dosimetric and acute toxicity improvements in prostate cancer treatment.

9. thegreenjournal.com thegreenjournal.com/article/S0167-8140(21)09061-7/fulltext

Online adaptive radiotherapy potentially reduces toxicity for ... In conclusion, high-risk prostate cancer patients will potentially experience significantly less acute gastrointestinal toxicity as well as ...