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

Trial Summary

What is the purpose of this trial?

This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.

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 High Dose Rate Brachytherapy for prostate cancer?

Research shows that High Dose Rate Brachytherapy, when used as a boost with other radiation treatments, improves survival rates and controls cancer better in patients with prostate cancer, especially those with higher risk factors. ^{1 2 3 4 5}

Is high dose rate brachytherapy safe for humans?

High dose rate brachytherapy is generally considered safe for treating prostate cancer, with studies showing it is effective and has manageable short-term side effects. Some research has focused on specific risks like urethral strictures (narrowing of the tube that carries urine out of the body), but overall, it is seen as a safe treatment option. ^{1 3 6 7 8}

How is high dose rate brachytherapy different from other prostate cancer treatments?

High dose rate brachytherapy for prostate cancer is unique because it delivers a highly targeted and intense dose of radiation directly to the prostate, exploiting the cancer's sensitivity to radiation. Unlike traditional external beam radiation, this method allows for a higher biological dose in fewer sessions, potentially improving treatment outcomes while minimizing exposure to surrounding healthy tissues. ^{1 6 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

High dose rate brachytherapy for prostate cancer: Standard of care and future direction. [2022]

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

High dose rate brachytherapy as a boost for the treatment of localized prostate cancer. [2006]

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

High dose rate and external beam radiotherapy in locally advanced prostate cancer. [2009]

4. United States 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. [2004]

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

Improved survival for patients with prostate cancer receiving high-dose-rate brachytherapy boost to EBRT compared with EBRT alone. [2019]

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

Urethral strictures following high-dose-rate brachytherapy for prostate cancer: analysis of risk factors. [2022]

7. Poland pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy delivered in two fractions as monotherapy for low-risk prostate cancer. [2020]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy in the curative treatment of patients with localized prostate cancer. [2018]

10. Egypt pubmed.ncbi.nlm.nih.gov

Brachytherapy for prostate cancer: a systematic review. [2021]

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

High-dose-rate brachytherapy as monotherapy for prostate cancer. [2018]