Radiation Therapy Planning for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Nathan Y. Yu, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Mayo Clinic

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase III trial compares the effects of radiation therapy using RapidPlan, trademark, knowledge-based planning to human-driven planning in treating patients with prostate cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Successful delivery of radiation requires planning to develop a treatment plan for how and where the radiation is to be delivered. RapidPlan is a knowledge-based treatment planning tool that automatically creates an optimal treatment plan based on identified targets and organs at risk for radiation exposure. Human-driven treatment planning by a dosimetrist, the current standard of care, requires significant resources and time and may vary within and among radiation centers. Giving radiation therapy with RapidPlan knowledge-based planning may have similar or less side effects compared to human-driven planning in treating patients with prostate cancer.

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 data supports the effectiveness of the treatment RapidPlan for prostate cancer?

Research shows that RapidPlan, a knowledge-based planning tool, is effective in creating treatment plans for prostate cancer using a method called volumetric modulated arc therapy (VMAT). Studies indicate that RapidPlan can produce treatment plans that are comparable to or better than those manually optimized, suggesting it is a viable option for prostate cancer treatment. ^{1 2 3 4 5}

Is radiation therapy for prostate cancer generally safe for humans?

Radiation therapy for prostate cancer, including three-dimensional conformal radiation therapy (3DCRT), is generally well-tolerated with low rates of serious complications. Studies show that acute severe reactions are rare, and chronic severe complications are uncommon, with a trend towards reduced toxicity when using 3DCRT compared to conventional methods. ^{6 7 8 9 10}

How is the RapidPlan treatment for prostate cancer different from other treatments?

RapidPlan is unique because it uses a knowledge-based model to automate the planning of radiation therapy, specifically volumetric modulated arc therapy (VMAT), for prostate cancer. This approach can improve the efficiency and consistency of treatment planning, potentially reducing treatment times and the need for manual adjustments compared to traditional methods. ^{1 2 4 11 12}

Research Team

Nathan Y. Yu, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• RapidPlan (Procedure)

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.

Participant Groups

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+

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

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]

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 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 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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2018]

2. Italy pubmed.ncbi.nlm.nih.gov

Dosimetric comparison of RapidPlan and manually optimized plans in volumetric modulated arc therapy for prostate cancer. [2018]

3. India pubmed.ncbi.nlm.nih.gov

Validation of RapidPlan Knowledge-Based Model for Volumetric-Modulated Arc Therapy in Prostate Cancer. [2023]

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

Radiotherapy treatment plans with RapidArc for prostate cancer involving seminal vesicles and lymph nodes. [2022]

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

Impact of a multileaf collimator on treatment morbidity in localized carcinoma of the prostate. [2019]

6. United States 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. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Postoperative radiotherapy for prostate cancer : Morbidity of local-only or local-plus-pelvic radiotherapy. [2018]

8. Sweden pubmed.ncbi.nlm.nih.gov

Long-term adverse effects after curative radiotherapy and radical prostatectomy: population-based nationwide register study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Complications of treatment with local field external beam radiotherapy for localized prostate cancer. [2019]

10. Canada 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. [2015]

11. India 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. [2022]

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

A RapidArc planning strategy for prostate with simultaneous integrated boost. [2021]