Adaptive SABR for Prostate Cancer

(RIPCORD Trial)

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Overseen ByDANIEL YANG, MD
Age: 18+
Sex: Male
Trial Phase: Phase < 1
Sponsor: University of Texas Southwestern Medical Center
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat prostate cancer that has spread but still responds to hormone therapy, which lowers male hormones. Researchers aim to understand how adaptive stereotactic ablative radiotherapy (SABR), a precise radiation therapy, can target cancer identified on PSMA PET scans and reduce tumor size and spread. Men with prostate cancer that has spread to 4-20 areas and who plan to receive hormone therapy might be suitable for this study. The trial excludes those who have had previous radiation to the same cancer sites or have certain health conditions that make radiation risky. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any other PSMA-directed investigational agents for the treatment of the cancer under study.

What prior data suggests that adaptive stereotactic ablative radiotherapy (SABR) is safe for prostate cancer treatment?

Research has shown that stereotactic ablative body radiotherapy (SABR) is generally safe and well-tolerated by patients with prostate cancer. One study found SABR effective without causing severe immediate side effects. However, about 15.7% of patients experienced some urinary issues later. Another study suggested that SABR might lead to fewer quality of life side effects compared to typical radiation treatments for prostate cancer. Overall, SABR appears to be a promising and safe treatment option, though some side effects may occur over time.12345

Why do researchers think this study treatment might be promising?

Adaptive stereotactic ablative radiotherapy (SABR) is unique because it offers a precise, high-dose radiation treatment that targets cancer cells more accurately than traditional radiotherapy. This precision minimizes damage to surrounding healthy tissue, which is a significant advantage over standard treatments like external beam radiotherapy. Researchers are excited about this approach as it could potentially improve outcomes and reduce side effects for patients with poly-metastatic hormone-sensitive prostate cancer. Additionally, the adaptive nature of SABR allows for real-time adjustments during treatment, enhancing its effectiveness against rapidly changing cancer conditions.

What evidence suggests that adaptive SABR is effective for prostate cancer?

Research has shown that stereotactic ablative radiotherapy (SABR) can effectively treat prostate cancer. For some patients, it has slowed disease progression, with only about 19% experiencing worsening within six months. In another study, SABR significantly reduced prostate-specific antigen (PSA) levels, a marker for monitoring prostate cancer. Some patients saw their PSA levels drop by more than 50%, and a few even had undetectable levels. SABR has also improved outcomes for those with limited cancer spots, suggesting it might control the disease well. Overall, SABR shows promise, especially for prostate cancer that hasn't spread widely. Participants in this trial will receive SABR as part of the study's single treatment arm.35678

Who Is on the Research Team?

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DANIEL YANG, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer that has spread to multiple areas but still responds to hormone therapy. Participants should be healthy enough for scans and targeted radiation, and not have conditions that would interfere with treatment or study participation.

Inclusion Criteria

I am 18 years old or older.
I am able to care for myself and perform daily activities.
At the discretion of the treating investigator, it is believed safe to treat all sites of disease using SABR
See 5 more

Exclusion Criteria

I have had radiation to the areas of cancer being targeted for this treatment.
History of allergic reactions to PMSA-11 68Ga imaging agent
Uncontrolled intercurrent illness or psychiatric/social situations limiting compliance with study requirements as judged by investigator
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Systemic Therapy

Participants undergo standard of care systemic therapy, including ADT and androgen receptor signaling inhibitors intensification, for up to 3 months before protocol radiotherapy

12 weeks

Radiotherapy

Delivery of SABR to metastatic sites in three qWeekly pulses, with potential for two additional pulses based on interim PSMA PET response

5-10 weeks

Interim Assessment

Interim PSMA PET imaging to evaluate response at 6 months from initiation of ADT

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up scans to monitor PSMA avid lesions

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • 68-Ga PSMA11
  • Adaptive stereotactic ablative radiotherapy (SABR)

Trial Overview

The study uses a special PET scan (68-Ga PSMA11) to see how well the cancer responds, then adjusts high-precision radiation therapy (SABR) based on those results. The goal is to better target tumors while minimizing unnecessary treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SINGLE ARM UNBLINDED SINGLE SITE PILOTExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Varian, a Siemens Healthineers Company

Industry Sponsor

Trials
35
Recruited
7,200+

Telix Pharmaceuticals (Innovations) Pty Ltd

Industry Sponsor

Trials
3
Recruited
870+

Citations

Stereotactic ablative body radiotherapy in patients with ... - PMC

Efficacy for SABR appears to be similar to brachytherapy including positive biopsy rates 2–3 years post treatment, biochemical failure (BF) rates out to 10-year ...

A Phase 2 Trial of Radium223 and Stereotactic Ablative ...

Eleven (55%) and 5 (25%) patients had PSA declines exceeding 50% and 90%, respectively, with 2 patients achieving undetectable PSA levels (<0.01) at 2 years. ...

Stereotactic Ablative Radiation Yields Good Outcomes for ...

The main outcome measures was six-month progression, measured by prostate-specific antigen level increase, conventional imaging, and symptoms; ...

SABR for Metastatic Prostate Cancer

One study found that SABR improved outcomes for patients with a few cancer spots, helping to control the disease. Another study showed promising results with ...

Outcomes of Observation vs Stereotactic Ablative ...

Treatment with SABR for oligometastatic prostate cancer improved outcomes and was enhanced by total consolidation of disease identified by PSMA ...

Adaptive Radiation Therapy (ART) Stereotactic Ablative ...

ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR. ...

Salvage stereotactic MR-Guided adaptive radiotherapy ...

73.7 %, and LC reached 84.2 % • No acute ≥ G3 toxicity; late grade 3 GU events occurred in 15.7 % of patients. EBRT reported unacceptably high toxicity rates

Phase II Randomized Trial of 2 Versus 5 Fraction Prostate ...

Small studies suggest prostate SABR in 2 fractions may be highly effective and well tolerated. However, there is little available data comparing 2 and 5 ...