High-Dose Radiotherapy for Prostate Cancer

(PROSINT Trial)

Not currently recruiting at 1 trial location

Overseen By Hilda Haynes-Lewis

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Metastatic disease, T3/T4 stage, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two high-dose radiotherapy treatments for men with prostate cancer. It evaluates the effectiveness and safety of these treatments for individuals with intermediate-risk prostate cancer, where the cancer is more likely to grow but hasn't spread. Participants will receive either a single high-dose treatment (IGRT 24 Gy single dose) or multiple smaller doses over five days (IGRT 45 Gy in 5 fractions of 9 Gy). Men with untreated prostate cancer and specific test results, such as a PSA level of 10-20, might be suitable candidates. The study will monitor participants for side effects and track their health over several years. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in prostate cancer care.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, alpha blockers are allowed if you have an International Prostate Symptom Score of 15 or less.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both treatment options in this study have promising safety records. For the IGRT 24 Gy single dose, studies found low rates of side effects. Patients generally maintained a similar quality of life compared to those receiving traditional treatments, with fewer urinary issues.

For the IGRT 45 Gy given in 5 sessions of 9 Gy each, past studies with similar doses reported good early results and acceptable side effects. Specifically, doses up to 47.5 Gy in five sessions have been used successfully with manageable side effects.

Overall, previous research indicates that both treatments are well-tolerated. However, since this study is in an earlier phase, it continues to assess the long-term safety and effectiveness of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they offer innovative approaches that could enhance convenience and potentially improve outcomes. Unlike traditional radiotherapy, which often requires multiple sessions over several weeks, the IGRT 24 Gy single-dose treatment delivers all the radiation in just one session. This could significantly reduce the time and effort required for patients. Meanwhile, the IGRT 45 Gy treatment is delivered in five fractions, allowing for a more intense dose over a shorter period compared to conventional methods, which may increase its effectiveness. These methods utilize Image-Guided Radiotherapy (IGRT) to precisely target the tumor, potentially minimizing damage to surrounding healthy tissues.

What evidence suggests that this trial's radiotherapy regimens could be effective for intermediate-risk prostate cancer?

Research has shown that high-dose image-guided radiotherapy (IGRT) effectively treats prostate cancer. In this trial, participants will receive either a single dose of 24 Gy or five doses of 9 Gy, totaling 45 Gy. Studies have found that both dosing regimens yield similar results. Specifically, patients who received high-dose IGRT experienced lower rates of long-term urinary problems, approximately 10.4%. Daily use of IGRT also helped prevent cancer recurrence over three years. Overall, these treatments offer promising results with manageable side effects for prostate cancer patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Madhur Garg, MD

Principal Investigator

Associate Clinical Director

Are You a Good Fit for This Trial?

Men over 50 with intermediate-risk prostate cancer, which means a Gleason score of 7, PSA levels between >10 and ≤20 ng/mL, and no evidence of spread beyond the prostate. They must have good performance status (able to carry out daily activities), a prostate size ≤100 grams, and an International Prostate Symptom Score ≤15.

Inclusion Criteria

My prostate cancer has a Gleason score of 7.

Signed study specific informed consent form

PSA ≤ 20 ng/mL

Exclusion Criteria

My prostate cancer has spread to my lymph nodes or other parts of my body.

PSA > 20 ng/mL

My cancer is at an advanced stage according to MRI results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 45 Gy in 5 fractions of 9 Gy each over one week or 24 Gy in a single session

1 week

5 visits (in-person) for arm A, 1 visit (in-person) for arm B

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 month, every 3 months for 12 months, and every 6 months thereafter

5 years

Regular visits every 3 to 6 months

Imaging and Biopsy Assessment

Multiparametric MRI performed at baseline, 6, 12, and 24 months; post-treatment DW-MRI within 15 minutes of first treatment; prostate needle biopsies at 24 months

24 months

What Are the Treatments Tested in This Trial?

Interventions

• IGRT 24 Gy single dose
• IGRT 45 Gy in 5 fractions of 9 Gy

Trial Overview The study is testing two high-dose radiation treatments using IGRT technology for men with intermediate-risk prostate cancer. One group will receive a single dose of 24 Gy; another will get five doses at 9 Gy each. The trial aims to compare outcomes and side effects like urinary, rectal, and sexual function.

How Is the Trial Designed?

Group I: IGRT 24 Gy single dose Experimental Treatment 4 Interventions

single fraction IGRT at a prescription dose of 24 Gy

Group II: IGRT 45 Gy in 5 fractions of 9 Gy Active Control 4 Interventions

Hypofractionated IGRT at a prescription dose of 45 Gy in 5 fractions of 9 Gy delivered in five consecutive days

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Published Research Related to This Trial

Patients treated with high-dose image-guided radiotherapy (IGRT) for prostate cancer experienced significantly lower rates of late urinary toxicity (10.4%) compared to those treated with high-dose intensity-modulated radiotherapy (IMRT) (20.0%), indicating a safer profile for IGRT.

For high-risk prostate cancer patients, IGRT not only reduced urinary toxicity but also improved biochemical tumor control compared to IMRT, suggesting that daily tracking of target positioning enhances treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved clinical outcomes with high-dose image guided radiotherapy compared with non-IGRT for the treatment of clinically localized prostate cancer. Zelefsky, MJ., Kollmeier, M., Cox, B., et al.[2022]

In a study of 100 prostate cancer patients treated with high-dose intensity-modulated radiotherapy (IMRT) and image-guided treatment (IGRT), acute gastrointestinal (GI) toxicity was observed in 12% and genitourinary (GU) toxicity in 42%, with only 4% experiencing severe GU toxicity (grade 3).

After a median follow-up of 26 months, late toxicity rates were low, with only 1.5% experiencing late GI toxicity and 7.7% experiencing late GU toxicity, indicating that high-dose radiotherapy is both effective and has manageable safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity after intensity-modulated, image-guided radiotherapy for prostate cancer. Guckenberger, M., Ok, S., Polat, B., et al.[2022]

Patients with high-risk prostate cancer treated with image-guided intensity-modulated radiotherapy (IG-IMRT) experienced significantly lower rates of gastrointestinal (GI) toxicity (5.8%) compared to those treated with 3D conformal radiotherapy (3DCRT) (57.3%), indicating that IG-IMRT is a safer option.

Both IG-IMRT and 3DCRT showed similar rates of biochemical progression-free survival at 3 years (90.3% for IG-IMRT vs. 86.0% for 3DCRT), suggesting that while IG-IMRT reduces toxicity, it does not compromise treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance. Sveistrup, J., af Rosenschöld, PM., Deasy, JO., et al.[2021]

In a study of 260 men with localized prostate cancer treated with high-dose IGRT and IMRT, the combination resulted in a low rate of late toxicity, with only 4.4% experiencing grade 2 gastrointestinal issues and 7.1% with grade 2 genitourinary issues after 7 years.

The treatment showed high efficacy, with a 7-year prostate-specific antigen relapse-free survival rate of 97.1% for low-risk patients, indicating that this approach is both safe and effective for managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Results of IGRT in Prostate Cancer Treatment. Doležel, M., Odrážka, K., Vaňásek, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12392665/

Comprehensive one-day management of prostate cancer ... A phase II trial comparing 45 Gy/5 fr vs. 24 Gy/1 fr showed similar outcomes [36]. The 24 Gy/1 fr was proposed due to a phase III trial ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04035642

Phase II Study of Single-Dose Image-Guided Radiotherapy ... The present study evaluates clinical outcomes and treatment-related toxicity following definitive ultra-high single dose external beam radiotherapy.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405630822001008

The role of image-guided radiotherapy in prostate cancer Compared with weekly IGRT, high-frequency daily IGRT could lead to greater 3-year biochemical failure-free survival (BFFS) benefit in prostate cancer patients.

4. withpower.com withpower.com/trial/phase-3-prostatic-neoplasms-7-2016-e864e

High-Dose Radiotherapy for Prostate Cancer Patients treated with high-dose image-guided radiotherapy (IGRT) for prostate cancer experienced significantly lower rates of late urinary toxicity (10.4%) ...

5. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00102-6/fulltext

18-month results of a single arm, multicenter phase I/II trial Prospective, multicenter, phase I/II trial of 19 Gy single fraction prostate SBRT. Urinary and rectal toxicity was mild at the 18-month follow-up.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7953338/

Safety and Efficacy of Virtual Prostatectomy With Single-Dose ... 24 Gy SDRT yielded low toxicity, prostate-specific antigen responses, and patient-reported quality-of-life measures akin to curative 5 × 9 Gy SBRT.