High Dose Rate Brachytherapy for Prostate Cancer

(SHAPE-PSMA Trial)

Overseen By Peter Chung, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Metastases, GI/GU toxicities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1-3 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests High Dose Rate Brachytherapy for men whose prostate cancer has returned after surgery and initial radiation. The goal is to determine if this treatment can effectively target cancer in the prostate bed area, where the prostate used to be. It is intended for those with recurrent prostate cancer after radiation and rising PSA levels (a protein made by the prostate). Candidates should not have distant metastases or severe side effects from previous radiation. This trial aims to offer another option for managing recurring prostate cancer. As an unphased trial, it provides a unique opportunity to explore new treatment possibilities for this condition.

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 prior data suggests that High Dose Rate Brachytherapy is safe for prostate cancer treatment?

Previous studies have shown that High Dose Rate (HDR) brachytherapy is safe for treating prostate cancer. Research indicates it can be a good option for patients whose cancer has returned after other treatments. Patients in these studies experienced positive outcomes with HDR brachytherapy. For example, the treatment helped many remain cancer-free for several years.

Some studies reported side effects, but serious ones are rare. Most side effects are mild or moderate and can include temporary urinary issues. Overall, patients tolerate HDR brachytherapy well. This treatment is already used in other prostate cancer therapies, suggesting it has a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about High Dose Rate (HDR) Brachytherapy for prostate cancer because it offers a precise, targeted treatment that is different from traditional options like external beam radiation. Unlike standard treatments, HDR Brachytherapy delivers high doses of radiation directly to the prostate tumor through implanted radioactive sources, minimizing damage to surrounding healthy tissues. This method is particularly promising for prostate bed recurrences after prior radiotherapy, where precision is crucial. By focusing the radiation more accurately, HDR Brachytherapy aims to enhance treatment effectiveness while reducing side effects, which is why it's gaining attention in the medical community.

What evidence suggests that High Dose Rate Brachytherapy might be an effective treatment for prostate cancer?

Studies have shown that High Dose Rate (HDR) Brachytherapy can effectively treat prostate cancer that returns after initial radiation therapy. In this trial, participants will receive HDR Brachytherapy as a salvage treatment for prostate bed recurrence. Research indicates that HDR Brachytherapy is safe and effective for carefully selected patients with localized cancer recurrence. It has controlled cancer long-term without requiring additional hormone treatments. Evidence supports its successful implementation with positive outcomes. Overall, HDR Brachytherapy offers a promising option for those facing prostate cancer recurrence. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for men over 18 with prostate cancer that has come back in the area where their prostate used to be. They must have had radiation therapy before, show signs of recurrence through tests like biopsy or scans, and have rising PSA levels above 0.2 ng/dl after treatment.

Inclusion Criteria

I have had radiation therapy to the prostate or pelvic area before.

My prostate cancer recurrence was confirmed by a biopsy, MRI, or PSMA-PET scan.

My PSA levels have risen twice after radiation therapy, now above 0.2 ng/dl.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including QoLs questionnaires, PSA, and pelvic MRI scan for RT planning

1-2 weeks

Treatment

Two fractions of 13 Gy each delivered over 7-21 days with GTV(HDR) delineation based on MRI-guided and PSMA PET, biopsy data

1-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PSA, CTCAE v5.0, MRI pelvis, and optional PSMA-PET scan

60 months

What Are the Treatments Tested in This Trial?

Interventions

• High Dose Rate Brachytherapy

Trial Overview

The study is testing a procedure called salvage MR-guided High-Dose-Rate brachytherapy on patients whose prostate cancer returned after initial radiotherapy. It's a single-group trial to see if this targeted high-dose radiation can treat the cancer effectively.

How Is the Trial Designed?

Group I: 2xHDR Brachytherapy Experimental Treatment 1 Intervention

Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed recurrence after Postoperative Radiotherapy.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

High dose rate brachytherapy is an effective treatment for localized prostate cancer, allowing for higher radiation doses per session compared to traditional external beam radiation.

This method takes advantage of the unique characteristics of prostate cancer cells, specifically their low alpha/beta ratio, to deliver a biologically effective dose that significantly exceeds what is possible with conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High dose rate brachytherapy for prostate cancer: Standard of care and future direction. Thiruthaneeswaran, N., Hoskin, PJ.[2022]

In a study of 207 prostate cancer patients with poor prognostic factors, a high dose rate brachytherapy boost combined with pelvic radiotherapy resulted in a 5-year biochemical control rate of 74%, with even higher rates for patients with fewer poor prognostic factors.

The treatment demonstrated a high overall survival rate of 92% and low complication rates (8% for severe genitourinary issues), indicating that this approach is both effective and safe for managing advanced prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conformal high dose rate brachytherapy improves biochemical control and cause specific survival in patients with prostate cancer and poor prognostic factors. Martinez, A., Gonzalez, J., Spencer, W., et al.[2004]

High-dose-rate brachytherapy is an effective curative treatment for localized prostate cancer, utilizing advanced technology to deliver precise radiation doses to the tumor.

The review of clinical studies from 2002 to 2007 indicates that this treatment can be used alone or in combination with external-beam radiotherapy, highlighting its versatility in cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy in the curative treatment of patients with localized prostate cancer. Pisansky, TM., Gold, DG., Furutani, KM., et al.[2018]

In a study of 131 prostate cancer patients treated with high dose rate brachytherapy and external beam radiation, the 5-year biochemical control rate was 81%, indicating effective cancer management over a median follow-up of 62.8 months.

The treatment was associated with minimal severe complications, with only 1.5% experiencing grade 3 acute urinary toxicity and 4% having grade 3 late genitourinary toxicity, demonstrating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High dose rate and external beam radiotherapy in locally advanced prostate cancer. Viani, GA., Pellizzon, AC., Guimarães, FS., et al.[2009]

In a study of 164 men treated with high-dose-rate (HDR) brachytherapy for prostate cancer, the procedure showed a low incidence of genitourinary (GU) and gastrointestinal (GI) complications, indicating it is a safe treatment option.

With a median follow-up of 18.6 months, HDR brachytherapy resulted in a high overall survival rate of 98.7% and a disease-free survival rate of 96.2%, demonstrating its efficacy in treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results. Zhang, H., Kang, S., Ali, N., et al.[2022]

In a study of 309 prostate cancer patients treated with high dose rate brachytherapy and external beam radiation, the 5-year biochemical control rate was 86%, indicating effective cancer management over the follow-up period of 59 months.

The treatment was associated with minimal severe complications, with only 2 cases of grade 3 acute urinary toxicity and 4% experiencing grade 3 genitourinary toxicity, demonstrating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High dose rate brachytherapy as a boost for the treatment of localized prostate cancer. Phan, TP., Syed, AM., Puthawala, A., et al.[2006]

In a study of 354 prostate cancer patients treated with high-dose-rate brachytherapy, the overall risk of developing a urinary stricture was 8.2% at 2 years, with significant variation based on the radiation dose schedule used.

Patients receiving the 19Gy/2 dose schedule had a notably high 2-year stricture risk of 31.6%, leading to a protocol modification to reduce this risk, as most strictures were mild and required minimal intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urethral strictures following high-dose-rate brachytherapy for prostate cancer: analysis of risk factors. Hindson, BR., Millar, JL., Matheson, B.[2022]

High-dose-rate (HDR) brachytherapy is a safe and effective treatment for low-risk prostate cancer, with 45% of patients experiencing some form of acute toxicity, primarily grade 1 urinary toxicity, within three months post-treatment.

The study found that urinary toxicity was significantly linked to the dose received by the urethra, with patients receiving over 111.3% of the prescribed dose being four times more likely to experience urinary issues, highlighting the importance of careful dose management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy delivered in two fractions as monotherapy for low-risk prostate cancer. Cendales, R., Alwers, E., Cifuentes, J., et al.[2020]

Patients with intermediate- to high-risk prostate cancer who received a high-dose-rate (HDR) brachytherapy boost along with 3D conformal radiotherapy (3DCRT) showed significantly better overall survival rates at 5, 10, and 15 years compared to those who received 3DCRT alone, with survival rates of 92%, 81%, and 67% versus 88%, 71%, and 53%, respectively.

The HDR boost group also demonstrated improved cause-specific survival rates, indicating that this treatment combination not only prolongs life but also effectively targets cancer progression, with cause-specific survival rates of 96%, 93%, and 87% for the HDR group compared to 95%, 88%, and 79% for the 3DCRT group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved survival for patients with prostate cancer receiving high-dose-rate brachytherapy boost to EBRT compared with EBRT alone. Kent, AR., Matheson, B., Millar, JL.[2019]

Low-dose rate brachytherapy is a widely accepted treatment for prostate cancer, showing excellent long-term outcomes across various risk levels, largely due to patient advocacy for less invasive options.

High-dose-rate (HDR) brachytherapy offers significant advantages, such as reduced risks associated with source loss and the absence of long-term radioprotection issues, making it a beneficial option for localized prostate cancer either alone or in combination with external-beam radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brachytherapy for prostate cancer: a systematic review. Koukourakis, G., Kelekis, N., Armonis, V., et al.[2021]

High-dose-rate (HDR) brachytherapy as a monotherapy for prostate cancer shows excellent outcomes, with prostate-specific antigen progression-free survival rates ranging from 79% to 100% and local control rates between 97% and 100% over follow-up periods of 1.5 to 8 years.

The treatment is associated with low toxicity rates, with genitourinary complications occurring in 0-16% of patients and gastrointestinal complications in 0-2%, while preserving erectile function in 67-89% of cases, indicating it is a safe and effective option for managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy as monotherapy for prostate cancer. Demanes, DJ., Ghilezan, MI.[2018]

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