What is the mechanism of action of this treatment?

Prostate cancer treatments such as stereotactic ablative radiotherapy (SABR) and androgen deprivation therapy (ADT) work through different mechanisms to target cancer cells. SABR delivers high doses of radiation precisely to the tumor while sparing surrounding tissues like the urethra, rectum, and pudendal arteries, reducing side effects and improving quality of life. ADT reduces androgen levels or blocks their effect on prostate cancer cells, slowing tumor growth. Novel imaging techniques like [18F]DCFPyL PET-MRI/CT enhance the detection of cancerous lesions, allowing for more targeted and effective treatments. These mechanisms are crucial as they aim to maximize cancer control while minimizing adverse effects, thereby improving patient outcomes.

What side effects are associated with this type of intervention?

Common side effects of high-dose radiation therapies for prostate cancer include urinary incontinence, urgency, bowel frequency, urgency, and sexual dysfunction. These symptoms can persist for years but may lessen over time. SUPR-SABR, which spares the urethra, rectum, and pudendal arteries, aims to reduce these genitourinary and gastrointestinal toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including radioligand therapies such as Lutetium Lu 177 vipivotide tetraxetan for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). This therapy has shown significant improvements in progression-free and overall survival. Additionally, stereotactic ablative radiation therapy (SABR) is a targeted high-dose radiation treatment that has been explored for prostate cancer, although specific FDA approvals for SABR with sparing of the urethra, rectum, and pudendal arteries, as studied in the SUPR-SABR trial, are not detailed. Other approved treatments include androgen receptor signaling inhibitors like enzalutamide and abiraterone, which are often used in combination with other therapies.

What other types of research exist?

Promising novel alternatives to SUPR-SABR for prostate cancer patients include: 1) Actinium-225-PSMA-617 therapy, which has shown significant biochemical response and quality-of-life improvements in heavily pretreated metastatic castration-resistant prostate cancer (mCRPC) patients. 2) Cesium-131 brachytherapy, which offers excellent long-term biochemical control and survival outcomes comparable to other isotopes like Iodine-125 and Palladium-103. 3) Beta-emitting radioisotopes such as Lutetium-177, which have demonstrated promising results in early-phase studies and are advancing through clinical trials.

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Radiation

SUPR-SABR Treatment for Prostate Cancer (SUPR-SABR Trial)

N/A

Recruiting

Led By Harriet Eldredge-Hindy, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new high-dose radiation treatment for men with low- and intermediate-risk prostate cancer. The treatment aims to protect important nearby areas like the urethra, rectum, and certain arteries. It uses precise imaging and positioning to focus radiation on the prostate while reducing side effects.

Who is the study for?

Men over 18 with untreated, localized prostate cancer (cT1-T2c, PSA<20 or <10 if on certain medications, Grade Group 1-3) and in good health can join. They must be able to undergo specific MRI scans for treatment planning and have a prostate volume less than 120 cc. Those with prior treatments for prostate cancer or other pelvic malignancies, distant metastases from prostate cancer, lymph node involvement by the disease, or severe urinary symptoms are excluded.

What is being tested?

The trial is testing SUPR-SABR—a high-dose radiation therapy targeting the prostate while sparing surrounding areas like the urethra and rectum. It aims to see if this method reduces side effects compared to standard SABR in treating low- and intermediate-risk prostate cancer.

What are the potential side effects?

Potential side effects may include genitourinary issues such as urinary frequency/urgency/incontinence and gastrointestinal problems like diarrhea or discomfort due to targeted high-dose radiation near sensitive areas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

12 month Expanded Prostate Cancer Index Composite (EPIC) gastrointestinal score

12 month Expanded Prostate Cancer Index Composite (EPIC) genitourinary score

Secondary study objectives

1 month genitourinary toxicity as assessed by the International Prostate Symptom Score (IPSS)

12 and 24 month erectile function as assessed by the Sexual Health Inventory for Men (SHIM) score.

24 month Expanded Prostate Cancer Index Composite (EPIC) gastrointestinal score

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SUPR-SABR treatmentExperimental Treatment1 Intervention

The prescription dose of this study will be 40 Gy in 5 fractions assigned to PTV_4000 which permits sparing of the rectum, urethra and pudendal artery. There will be a secondary dose level of 36.25 Gy in 5 fractions. A minimum dose of 36.25 Gy will be given to the entire prostate PTV_3625. 36.25 Gy in five fractions is currently endorsed as a standard of care for localized prostate cancer by the National Comprehensive Cancer Network guidelines in prostate cancer. Escalating the therapeutic radiation dose above 36.25 Gy provides potential for improved biochemical control of prostate cancer and decrease in relapse free survival.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments such as stereotactic ablative radiotherapy (SABR) and androgen deprivation therapy (ADT) work through different mechanisms to target cancer cells. SABR delivers high doses of radiation precisely to the tumor while sparing surrounding tissues like the urethra, rectum, and pudendal arteries, reducing side effects and improving quality of life. ADT reduces androgen levels or blocks their effect on prostate cancer cells, slowing tumor growth. Novel imaging techniques like [18F]DCFPyL PET-MRI/CT enhance the detection of cancerous lesions, allowing for more targeted and effective treatments. These mechanisms are crucial as they aim to maximize cancer control while minimizing adverse effects, thereby improving patient outcomes.

177Lu-PSMA for Extended Treatment of Metastatic Castration-Resistant Prostate Cancer.Two-fraction stereotactic ablative radiotherapy (SABR) versus two-fraction high dose rate (HDR) brachytherapy for localized prostate cancer: Does dose heterogeneity matter?[18F]DCFPyL PET-MRI/CT for unveiling a molecularly defined oligorecurrent prostate cancer state amenable for curative-intent ablative therapy: study protocol for a phase II trial.