Combined Radiotherapy for Prostate Cancer

(HYDRA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Stephanie M Yoon, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Neuroendocrine carcinoma, Invasive malignancy, Metastases, Inflammatory bowel disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

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 data supports the effectiveness of the treatment Combined Radiotherapy for Prostate Cancer?

Research shows that using CyberKnife, a type of precise radiation therapy, can effectively deliver high-dose radiation similar to HDR brachytherapy for prostate cancer. Early clinical observations and comparisons with other treatments suggest it may be a promising option for treating prostate cancer. ^{1 2 3 4 5}

Is combined radiotherapy for prostate cancer safe for humans?

Studies on treatments like CyberKnife and HDR Brachytherapy for prostate cancer show they are generally safe, with some patients experiencing mild to moderate side effects like urinary issues and proctitis (inflammation of the rectum). Most patients remained disease-free and alive at follow-up, indicating a good safety profile. ^{1 5 6 7 8}

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

This treatment combines high-dose-rate brachytherapy (internal radiation) and stereotactic body radiation therapy (CyberKnife), offering precise targeting of prostate cancer with potentially fewer side effects and shorter treatment times compared to traditional methods. It leverages the benefits of both internal and external radiation, making it a unique approach for localized prostate cancer. ^{1 2 5 9 10}

Eligibility Criteria

Men aged 18+ with intermediate to high-risk prostate adenocarcinoma (T1c-T3b, PSA > 10, Gleason score >=7) without metastases or prior major treatments for prostate cancer. They must be able to undergo sedation or anesthesia, have a prostate size <=60cc, and an ECOG performance status of 0-2.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I can safely undergo procedures with sedation or general anesthesia.

International Prognostic Scoring System (IPSS) score =< 15

Exclusion Criteria

I have had surgery or specific treatments for prostate cancer.

I have a history of inflammatory bowel disease or a high risk for radiation side effects.

I have had radiation treatment to my pelvis or seed implant therapy in my prostate.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo HDR-BT for up to 24 hours and SBRT every other day or consecutive days for up to 14 consecutive days

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Within 90 days, every 3 months for 24 months, then every 6 months

Treatment Details

Interventions

• High-Dose Rate Brachytherapy (Brachytherapy)
• Stereotactic Body Radiation Therapy (Radiation Therapy)

Trial Overview The trial is testing the combination of high dose-rate brachytherapy (internal radiation) and stereotactic body radiotherapy (precise external radiation). It aims to see if this approach effectively treats prostate adenocarcinoma with fewer doses and less damage to healthy tissue.

Participant Groups

Group I: Treatment (HDR-BT, SBRT) Experimental Treatment 2 Interventions

Patients undergo HDR-BT for up to 24 hours and undergo SBRT every other day or consecutive days for up to 14 consecutive chronologic days in the absence of disease progression or unacceptable toxicity.

High-Dose Rate Brachytherapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as High-Dose Rate Brachytherapy for:

• Prostate adenocarcinoma
• Cervical cancer
• Breast cancer
• Skin cancer

🇪🇺 Approved in European Union as High-Dose Rate Brachytherapy for:

• Prostate adenocarcinoma
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

🇨🇦 Approved in Canada as High-Dose Rate Brachytherapy for:

• Prostate adenocarcinoma
• Cervical cancer
• Breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California at Los Angeles / Jonsson Comprehensive Cancer Center Los Angeles, CA

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center Lead Sponsor

References

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

Virtual HDR CyberKnife treatment for localized prostatic carcinoma: dosimetry comparison with HDR brachytherapy and preliminary clinical observations. [2022] We tested our ability to approximate the dose (38 Gy), fractionation (four fractions), and distribution of high-dose-rate (HDR) brachytherapy for prostate cancer with CyberKnife (CK) stereotactic body radiotherapy (SBRT) plans. We also report early clinical observations of CK SBRT treatment.

2. Ireland pubmed.ncbi.nlm.nih.gov

Two-fraction stereotactic ablative radiotherapy (SABR) versus two-fraction high dose rate (HDR) brachytherapy for localized prostate cancer: Does dose heterogeneity matter? [2022] Contemporary radiotherapy for localized prostate cancer (PCa) is deliverable via stereotactic ablative radiotherapy (SABR) and high dose rate (HDR) brachytherapy. Here we report on a parallel cohort analysis of two prospective, phase II clinical trials of two-fraction prostate SABR versus two-fraction HDR monotherapy.

3. France pubmed.ncbi.nlm.nih.gov

[Robotic radiotherapy for prostate cancer with CyberKnife]. [2022] After 3D conformal radiation therapy without and with modulated intensity, image-guided radiation therapy represents a new technological step. Should prostate cancer treatment using radiotherapy with the CyberKnife robotic system be considered as a new treatment and then investigated through classical clinical research procedure rather than a technical improvement of an already validated treatment? After a general presentation of the CyberKnife , the authors focused on prostate cancer treatment assuming that, according to dosimetric and biological considerations, the treatment by robotic system appears comparable to high dose rate brachytherapy. For prostate cancer treatment are discussed: biological rational for hypofractionated treatment, high dose rate brachytherapy boost and interest of dose escalation. A comparison is presented between CyberKnife and other validated treatment for prostate cancer (radical prostatectomy, 3D conformal radiation therapy and low and high dose rate brachytherapy). In summary, CyberKnife treatment could be considered as a technical improvement of an already validated treatment in order to deliver a prostate boost after pelvic or peri-prostatic area irradiation. However, the clinical, biological and economical results must be precisely analyzed and could be assessed in the frame of a National Observatory based on shared therapeutic program.

4. Australia pubmed.ncbi.nlm.nih.gov

Clinical outcomes of whole pelvis radiotherapy and stereotactic body radiotherapy boost for intermediate- and high-risk prostate cancer. [2018] We report our experience with Cyberknife to deliver hypofractionated stereotactic body radiotherapy (SBRT) boost combined with whole pelvis radiotherapy (WPRT) to patients with intermediate- to high-risk prostate cancer.

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

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017] Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022] Stereotactic ablative radiation (SAbR) has been increasingly used in prostate cancer (PCa) given its convenience and cost efficacy. Optimal doses remain poorly defined with limited prospective comparative trials and long-term safety/efficacy data at higher dose levels. We analyzed toxicity and outcomes for SAbR in men with localized PCa at escalated 45 Gy in 5 fractions.

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

Cyberknife treatment for low and intermediate risk prostate cancer. [2015] Cyberknife is an emerging treatment for early stage prostate cancer. Between October 2012 and January 2014, 32 patients were treated in our institution. Prescribed dose was 35-36.25 Gy in five fractions. Biochemical response was observed in 22 patients. Four patients experienced G2 acute genitourinary toxicity and in two cases we recorded G3 acute GU toxicity. 5 patients experienced G2 acute proctitis. At last follow up visit, all patients were still alive. 29 remained free of disease at last follow up appointment, while three developed a biochemical recurrence. Our experience confirms the efficacy and safety of Cyberknife for localized prostate cancer.

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

Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022] We report the results of a retrospective study of stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer. The study focused on the safety and feasibility of this treatment modality.

9. Australia pubmed.ncbi.nlm.nih.gov

Treatment of localized prostate cancer using a combination of high dose rate Iridium-192 brachytherapy and external beam irradiation: initial Australian experience. [2019] Combination high dose rate brachytherapy (HDRB) and external beam radiation therapy is technically and clinically feasible as definitive treatment for localized prostate cancer. We report the first large Australian experience using this technique of radiation dose escalation in 82 patients with intermediate- and high-risk disease. With a median follow up of 3 years (156 weeks), complications were low and overall prostate-specific antigen progression-free survival was 91% using the American Society for Therapeutic Radiology and Oncology consensus definition. The delivery of hypofractionated radiation through the HDRB component shortens overall treatment time and is both biologically and logistically advantageous. As a radiation boost strategy, HDRB is easy to learn and could be introduced into most facilities with brachytherapy capability.

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

High-dose-rate brachytherapy for prostate cancer: Rationale, current applications, and clinical outcome. [2022] High-dose-rate brachytherapy (HDR BRT) has been enjoying rapid acceptance as a treatment modality offered to selected prostate cancer patients devoid of risk group, employed either in monotherapy setting or combined with external beam radiation therapy (EBRT) and is currently one of the most active clinical research areas.