Hypofractionated Radiation Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Stage T3-4, Gleason 4+3, Metastases, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

188 Participants Needed

Trial Summary

What is the purpose of this trial?

This will be a Phase II study evaluating the effectiveness and toxicity of a specific radiation therapy regimen. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. The total dose is calculated to be effective for late effects which has been shown to be effective and safe in a large prospective Phase II study. If the hypothesis for the prostate is is true, then this regimen should be at least as effective or more effective for tumor control than the current conventional therapy.

Do I need to stop my current medications for this trial?

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 the treatment Hypofractionated Radiation Therapy for Prostate Cancer?

Research shows that hypofractionated radiotherapy, which uses larger doses of radiation in fewer sessions, can improve prostate cancer control by delivering higher effective doses to the prostate. Studies indicate that this approach may enhance treatment outcomes without increasing side effects, making it a promising option for prostate cancer patients. ^{1 2 3 4 5}

Is hypofractionated radiation therapy safe for humans?

Hypofractionated radiation therapy for prostate cancer is generally considered safe, with studies showing it does not significantly increase long-term side effects. However, it may be associated with higher levels of short-term side effects, which require clinical management. ^{3 6 7 8 9}

How is hypofractionated radiation therapy different from other treatments for prostate cancer?

Hypofractionated radiation therapy for prostate cancer involves delivering higher doses of radiation in fewer sessions, which can reduce the number of treatment visits and potentially minimize side effects compared to traditional radiation therapy. This approach takes advantage of the unique radiobiology of prostate cancer, allowing for effective treatment with a shorter schedule. ^{1 2 10 11 12}

Research Team

Danny Song, MD

Principal Investigator

The Johns Hopkins University School of Medcine

Eligibility Criteria

Men with early-stage prostate cancer (Gleason score <7, PSA <10 ng/ml, stages T1a-T2b) who have chosen external beam radiation as their treatment can join. They must sign a consent form. Men with advanced cancer, high Gleason scores or PSA levels, previous major treatments for prostate cancer, other recent cancers (except certain skin/bladder cancers), inflammatory bowel disease, or serious medical/psychiatric issues cannot participate.

Inclusion Criteria

My prostate cancer is in an early stage and my PSA level is below 10 ng/ml.

My prostate cancer has a low Gleason score.

I have chosen external beam radiation to treat my prostate cancer.

Exclusion Criteria

My prostate cancer has a Gleason score of 7 or higher.

I have had chemotherapy or radiation therapy to the pelvis before.

I have a history of inflammatory bowel disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive hypofractionated radiation therapy with 3.6 Gy per day to a total dose of 57.6 Gy over 16 fractions

4 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after radiation therapy

12 weeks

Treatment Details

Interventions

• Hypofractionation

Trial Overview The trial is testing a specific type of radiation therapy called hypofractionation to see if it's effective and safe in treating localized adenocarcinoma of the prostate. This Phase II study builds on earlier research suggesting that this approach could control tumors better than conventional therapy.

Participant Groups

Group I: Hypofractionated radiation therapy in prostate adenocarcinoma Experimental Treatment 1 Intervention

Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).

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

Approved in European Union as Hypofractionation for:

• Soft tissue sarcomas
• Extremity soft tissue sarcomas
• Trunk soft tissue sarcomas

Approved in United States as Hypofractionation for:

• Soft tissue sarcomas
• Extremity soft tissue sarcomas
• Trunk soft tissue sarcomas

Approved in Canada as Hypofractionation for:

• Soft tissue sarcomas
• Extremity soft tissue sarcomas
• Trunk soft tissue sarcomas

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Findings from Research

In a study of 41 patients with high-risk localized prostate cancer, combining whole-pelvis irradiation with a stereotactic body radiotherapy (SBRT) boost resulted in a high 4-year biochemical failure-free survival rate of 91.9%, indicating effective cancer control.

The treatment was associated with minimal toxicity, with no severe (grade 3) gastrointestinal or genitourinary side effects reported, suggesting that this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Lin, YW., Lin, LC., Lin, KL.[2020]

Hypofractionated radiotherapy for prostate cancer, which delivers larger doses in fewer sessions, has shown improved biochemical control of the disease, supported by multiple clinical trials.

Advanced radiation techniques like 3D conformal radiotherapy and intensity modulated radiation therapy enable higher doses to the prostate while protecting surrounding healthy tissues, making hypofractionation a safer and more effective option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of hypofractionated radiotherapy for prostate cancer. Spyropoulou, D., Kardamakis, D.[2021]

In a study involving 457 men with localized prostate cancer, hypofractionated high-dose radiotherapy (60 Gy and 57 Gy) was found to be as well tolerated as conventional radiotherapy (74 Gy) over a median follow-up of 50.5 months, with low rates of grade 2 or worse bowel and bladder toxicities.

The rates of bowel toxicity were 4.3% for the conventional group, 3.6% for the 60 Gy group, and 1.4% for the 57 Gy group, indicating that hypofractionated treatment may not increase the risk of side effects compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Dearnaley, D., Syndikus, I., Sumo, G., et al.[2023]

Recent evidence suggests that hypofractionated radiotherapy for prostate cancer is both safe and effective, particularly with a recommended regimen of 60 Gy in 20 fractions, which showed no significant increase in late toxicity.

While moderate hypofractionation has demonstrated positive 5-year outcomes in large trials, further research is needed for extreme hypofractionation techniques, and their use should currently be restricted to clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionation for prostate cancer: an update. Tiberi, D., Vavassis, P., Nguyen, D., et al.[2019]

Moderate hypofractionated radiotherapy for prostate cancer is associated with a 6.3% increase in acute grade ≥ 2 gastrointestinal toxicity compared to standard fractionation, indicating a need for careful monitoring and management of these symptoms.

There was no significant increase in acute genitourinary toxicity or late toxicity levels between moderate hypofractionation and standard fractionation, suggesting that while acute GI symptoms may be more common, overall safety profiles for late effects are similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and late toxicity patterns of moderate hypo-fractionated radiotherapy for prostate cancer: A systematic review and meta-analysis. Sinzabakira, F., Brand, V., Heemsbergen, WD., et al.[2023]

In a study of 820 patients with localized prostate cancer, hypofractionated radiation therapy showed similar 5-year relapse-free survival rates compared to conventional radiation therapy, but it did not demonstrate noninferiority in terms of genitourinary and gastrointestinal quality of life.

While hypofractionation did not perform as well for urinary and gastrointestinal symptoms, it was found to be noninferior for other aspects of quality of life, such as symptoms related to androgen deprivation therapy and sexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate Hypofractionation in Intermediate- and High-Risk, Localized Prostate Cancer: Health-Related Quality of Life From the Randomized, Phase 3 HYPRO Trial. Wortel, RC., Oomen-de Hoop, E., Heemsbergen, WD., et al.[2019]

References

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

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. [2020]

2. Poland pubmed.ncbi.nlm.nih.gov

The rationale behind hypofractionated high-dose intensity-modulated radiotherapy in patients with localized prostate cancer: short review. [2013]

3. Egypt pubmed.ncbi.nlm.nih.gov

Review of hypofractionated radiotherapy for prostate cancer. [2021]

4. Greece pubmed.ncbi.nlm.nih.gov

Treatment of low-risk prostate cancer with radical hypofractionated accelerated radiotherapy with cytoprotection (HypoARC): an interim analysis of toxicity and efficacy. [2018]

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

Randomized Trial of Hypofractionated, Dose-Escalated, Intensity-Modulated Radiation Therapy (IMRT) Versus Conventionally Fractionated IMRT for Localized Prostate Cancer. [2022]

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

Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Hypofractionation for prostate cancer: an update. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Acute and late toxicity patterns of moderate hypo-fractionated radiotherapy for prostate cancer: A systematic review and meta-analysis. [2023]

9. India pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for localized prostate cancer using three-dimensional conformal radiotherapy technique: 3 years toxicity analysis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Phase I/II study of a five-fraction hypofractionated accelerated radiotherapy treatment for low-risk localised prostate cancer: early results of pHART3. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Hypofractionation for radiotherapy of prostate cancer using a low alfa/beta ratio--possible reasons for concerns? An example of five dimensional radiotherapy. [2018]

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

Moderate Hypofractionation in Intermediate- and High-Risk, Localized Prostate Cancer: Health-Related Quality of Life From the Randomized, Phase 3 HYPRO Trial. [2019]