Radiation Therapy Planning for Prostate Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Mayo Clinic

Disqualifiers: Previous pelvic radiation, Active rectal diverticulitis, Crohn's disease, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 5

Duration: 3-9 weeks

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two different planning methods for radiation therapy impact prostate cancer treatment. One method uses RapidPlan, a tool that automatically creates treatment plans, while the other relies on human planning. The goal is to determine if RapidPlan is as effective or better in terms of side effects compared to the human-driven approach. The trial seeks participants diagnosed with prostate cancer who plan to receive a specific type of radiation therapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking advancements in prostate cancer treatment.

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 team or your doctor.

What prior data suggests that RapidPlan is safe for radiation therapy planning in prostate cancer?

Research has shown that RapidPlan for radiation therapy might result in the same or fewer side effects compared to traditional human planning. Studies have found that RapidPlan creates treatment plans that target tumors while protecting healthy organs, potentially lowering the risk of unwanted side effects.

RapidPlan has been tested in various situations, and results suggest it is generally well-tolerated by patients. Radiation therapy typically causes side effects like skin irritation or tiredness, but these vary depending on the individual and the specific treatment plan. RapidPlan aims to reduce these risks by improving radiation delivery.

Overall, evidence suggests that RapidPlan is safe for use in radiation therapy. It might offer a more efficient and potentially safer option compared to traditional planning methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of RapidPlan, a new method for planning radiation therapy in prostate cancer treatment. Unlike traditional human-driven planning, RapidPlan uses advanced algorithms to optimize the therapy plan, potentially enhancing precision and efficiency. This could lead to improved targeting of cancer cells while sparing healthy tissues, ultimately aiming to reduce side effects and improve patient outcomes. Through this trial, researchers hope to determine if RapidPlan can offer a more effective and streamlined approach compared to the current standard of care.

What evidence suggests that RapidPlan is effective for prostate cancer?

This trial will compare two approaches to radiation therapy planning for prostate cancer. Research has shown that RapidPlan, a tool for designing radiation treatment plans, can effectively treat prostate cancer. Participants in one arm of this trial will receive treatment plans created with RapidPlan. Studies have found these plans to be as good as, or even better than, those made by people. RapidPlan also reduces the time needed to create these plans, allowing patients to start treatment sooner and potentially experience fewer side effects. Overall, RapidPlan appears to be a promising tool for improving prostate cancer treatment. ^{1 4 5 6 7}

Who Is on the Research Team?

Nathan Y. Yu, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with prostate cancer. Participants must be suitable for radiation therapy and willing to undergo various imaging procedures like MRI and PET scans, as well as provide biospecimens. Specific details about inclusion or exclusion criteria are not provided.

Inclusion Criteria

In case of confusion about the eligibility or ineligibility of an individual patient, the principal investigator (PI) can be used as the arbiter and a note to file will be added to the subject's regulatory binder to document outcome

Patients must sign Institutional Review Board (IRB) approved study specific informed consent

Patients must complete all required pre-entry tests within the specified time frames

Exclusion Criteria

Prior hip replacement or penile implant

Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (consent by legal authorized representative is not permitted for this study)

Indwelling or intermittent urinary catheter use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiation therapy with either human-driven or RapidPlan knowledge-based planning over 5-44 fractions

3-9 weeks

5-44 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up at 3 and 12 months, then yearly up to year 5

5 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RapidPlan

Trial Overview The study compares two methods of planning radiation therapy: RapidPlan knowledge-based planning versus traditional human-driven planning. The goal is to see if the new RapidPlan method can match or reduce side effects compared to the standard approach.

How Is the Trial Designed?

Group I: Arm B (RapidPlan treatment planning, radiation therapy) Experimental Treatment 6 Interventions

Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.

Group II: Arm A (human-driven treatment planning, radiation therapy) Active Control 6 Interventions

Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.

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 575 prostate cancer patients, those receiving pelvic radiotherapy experienced significantly higher early gastrointestinal (GI) side effects (42%) compared to those receiving local radiotherapy (26%), indicating a greater risk associated with pelvic treatment.

Late genitourinary (GU) morbidity was also higher in the pelvic radiotherapy group (24%) compared to the local group (18%), suggesting that advanced treatment techniques like IMRT or VMAT may be beneficial in reducing these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative radiotherapy for prostate cancer : Morbidity of local-only or local-plus-pelvic radiotherapy. Waldstein, C., Dörr, W., Pötter, R., et al.[2018]

Men with prostate cancer who underwent radiotherapy (RT) had a significantly higher risk of serious adverse effects compared to controls, with a relative risk (RR) of 2.64, while those who had radical prostatectomy (RP) had an RR of 2.05, indicating increased long-term risks associated with both treatments.

Specifically, the risk of surgical procedures for urinary incontinence was much higher after RP (RR 23.64), while RT was associated with higher risks for other lower urinary tract and gastrointestinal procedures, showing that both treatment options carry distinct long-term risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term adverse effects after curative radiotherapy and radical prostatectomy: population-based nationwide register study. Fridriksson, JÖ., Folkvaljon, Y., Nilsson, P., et al.[2022]

RapidArc (RA) demonstrated the highest efficiency in treating localized prostate cancer, significantly reducing treatment time to just 1.45-3.7 minutes per fraction, while also maintaining excellent coverage of the target areas.

Among the intensity-modulated techniques studied, helical tomotherapy (HT) provided the best sparing of surrounding organs, particularly the rectum and bladder, compared to traditional 3D conformal radiation therapy (3D CRT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Arc, helical tomotherapy, sliding window intensity modulated radiotherapy and three dimensional conformal radiation for localized prostate cancer: a dosimetric comparison. Kinhikar, RA., Pawar, AB., Mahantshetty, U., et al.[2022]

In a study involving 10 patients with high-risk prostate cancer, conventional intensity-modulated radiotherapy (IMRT) was found to better spare surrounding organs like the bladder and rectum compared to RapidArc plans, particularly for larger treatment areas.

However, RapidArc demonstrated greater efficiency in treatment delivery, reducing the time needed for radiation therapy by 2 to 7 minutes, making it a faster option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy treatment plans with RapidArc for prostate cancer involving seminal vesicles and lymph nodes. Yoo, S., Wu, QJ., Lee, WR., et al.[2022]

In a study of 4,363 men with low-risk prostate cancer, combined radiation therapy was found to be significantly more toxic than brachytherapy alone, leading to higher rates of genitourinary incontinence, obstruction, and erectile dysfunction.

Compared to external beam radiation therapy (EBRT) alone, combined therapy also resulted in increased gastrointestinal bleeding and other toxicities, suggesting that EBRT may offer protective benefits against these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The burden of overtreatment: comparison of toxicity between single and combined modality radiation therapy among low risk prostate cancer patients. Jiang, R., Tomaszewski, JJ., Ward, KC., et al.[2015]

The study demonstrated that RapidPlan (RP) knowledge-based treatment planning can create prostate VMAT plans that deliver comparable or improved doses to target volumes compared to traditional manual planning, based on an analysis of 120 treatment plans.

While RP models generally provided better or similar doses to normal organs like the bladder and rectum, those using automated priority optimization struggled to meet rectum dose constraints, highlighting the importance of model training size and optimization methods in achieving effective treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of RapidPlan Knowledge-Based Model for Volumetric-Modulated Arc Therapy in Prostate Cancer. Ayuthaya, IIN., Suriyapee, S., Sanghangthum, T.[2023]

In a study of 111 patients undergoing local field irradiation for localized prostate cancer, the rates of serious complications were low, with only 3.6% experiencing acute grade 3 or 4 urinary reactions, and no patients developing chronic bowel or skin complications greater than grade 2.

Three-dimensional conformal radiation therapy (3DCRT) showed a trend towards reduced toxicity compared to conventional radiation therapy, even with increased radiation doses, indicating that 3DCRT may enhance the safety profile of prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of treatment with local field external beam radiotherapy for localized prostate cancer. O'Sullivan, JM., Gribbin, A., Taylor, J., et al.[2019]

The study presents a streamlined planning strategy for RapidArc intensity-modulated radiotherapy (IMRT) for prostate cancer, which significantly reduces optimization time to about 15 minutes, enhancing efficiency in treatment planning.

This new approach not only maintains or improves dose distribution compared to traditional static gantry IMRT but also minimizes the influence of the planner's experience on the quality of the treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A RapidArc planning strategy for prostate with simultaneous integrated boost. Jolly, D., Alahakone, D., Meyer, J.[2021]

The study evaluated the RapidPlan (RP) knowledge-based engine for optimizing volumetric modulated arc therapy in prostate cancer, using data from 43 patients to create a model and validating it with 60 patients across 7 institutes.

Results showed that RP-generated plans were generally consistent with manually optimized plans, with some improvements in dose delivery, indicating that knowledge-based models can effectively be shared and utilized across different clinical centers for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intercenter validation of a knowledge based model for automated planning of volumetric modulated arc therapy for prostate cancer. The experience of the German RapidPlan Consortium. Schubert, C., Waletzko, O., Weiss, C., et al.[2018]

RapidPlan (RP) plans for volumetric modulated arc therapy (VMAT) in prostate cancer patients showed clinically acceptable results, with significant similarities to manually optimized plans in key dosimetric parameters like D95% and homogeneity index.

The RP plans demonstrated comparable or superior rectal dose metrics and reduced optimization time, suggesting that this automated approach can be effective regardless of the planner's experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric comparison of RapidPlan and manually optimized plans in volumetric modulated arc therapy for prostate cancer. Kubo, K., Monzen, H., Ishii, K., et al.[2018]

In a study of 123 prostate cancer patients treated with 3-dimensional conformal radiation therapy, only 32% experienced moderate acute side effects, indicating that this treatment is well-tolerated.

The treatment led to normalization of prostate specific antigen (PSA) levels in 67% of patients within a median of 4.5 months, suggesting a promising initial tumor response and effectiveness of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional conformal radiation therapy in locally advanced carcinoma of the prostate: preliminary results of a phase I dose-escalation study. Leibel, SA., Heimann, R., Kutcher, GJ., et al.[2019]

In a study of 245 patients over 9 years, using a multileaf collimator and three-dimensional treatment planning for neutron radiation therapy significantly improved local/regional tumor control rates for prostate cancer without increasing complications.

Compared to traditional photon treatments, the conformal neutron beam delivery resulted in a much lower rate of severe normal tissue complications (10% vs. 39%), highlighting the safety and efficacy of this advanced treatment technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a multileaf collimator on treatment morbidity in localized carcinoma of the prostate. Austin-Seymour, M., Caplan, R., Russell, K., et al.[2019]

Citations

1. nature.com nature.com/articles/s41598-025-08553-7

Systematic implementation of rapidplan for prostate cancer The model achieved clinical effectiveness comparable to or superior to that of the manual method while significantly reducing the planning time.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9747821/

A comparison of in-house and shared RapidPlan models for ... In this study, we assess the success of a using a publicly available KBP model compared with developing an in-house model for prostate cancer radiotherapy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06625034

Radiation Therapy With RapidPlan Knowledge-based ... This phase III trial compares the effects of radiation therapy using RapidPlan, trademark, knowledge-based planning to human-driven planning in treating ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405631622000446

Evaluating the utility of knowledge-based planning for ... The purpose of this study was to explore the potential of KBP as a powerful and efficient tool in clinical trials for QA and planning purposes.

5. scholarworks.gvsu.edu scholarworks.gvsu.edu/cgi/viewcontent.cgi?article=1665&context=gradprojects

Evaluating Dosimetric Outcomes in a Prostate Rapid Plan Model Knowledge-based planning (KBP) using RapidPlan (RP) has demonstrated the ability to produce high quality radiation therapy treatment plans ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0958394725000500

Effect of inter-planner variability on knowledge-based ... In this study, three planners independently constructed RapidPlan models using data from the same 30 prostate cancer patients. Each planner ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10795433/

Multi‐planner validation of RapidPlan knowledge‐based ... The treatment planning data for each plan was used to create and train the RP model. Twelve prostate cancer cases were selected and were used for planning by a ...