~24 spots leftby Dec 2025

Radiation Therapy for Prostate Cancer

(FORT Trial)

Recruiting in Palo Alto (17 mi)
+1 other location
HN
Overseen byHimanshu Nagar, M.D.
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Weill Medical College of Cornell University
Disqualifiers: Pelvic radiotherapy, Inflammatory bowel disease, others
No Placebo Group
Prior Safety Data
Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The study is a randomized study that compares 5 radiation therapy treatments to 2 radiation therapy treatments in men with low or intermediate-risk prostate cancer.

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 this treatment for prostate cancer?

Radiation therapy is a valid alternative to surgery for prostate cancer, with dose-escalated radiation improving patient outcomes. Techniques like intensity-modulated radiation therapy (IMRT) and stereotactic body radiotherapy (SBRT) have shown promise in improving local control and reducing side effects.12345

Is radiation therapy generally safe for prostate cancer treatment?

Research shows that advanced radiation therapy techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) are generally safe, with some patients experiencing mild to moderate side effects such as gastrointestinal (GI) and genitourinary (GU) issues. The use of these techniques can reduce the risk of side effects compared to older methods.678910

How is radiation therapy unique for treating prostate cancer?

Radiation therapy for prostate cancer, especially with advanced techniques like intensity-modulated radiation therapy (IMRT) and image-guided radiotherapy (IGRT), allows for higher doses of radiation to be delivered more precisely to the tumor, reducing damage to surrounding healthy tissue and potentially improving treatment outcomes compared to older methods.411121314

Research Team

HN

Himanshu Nagar, M.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for men over 18 with low or intermediate-risk prostate cancer, who are generally healthy and can undergo MRI-guided radiotherapy. They should not have had pelvic radiation before, no large prostate on MRI (>80 cc), no recent TURP surgery, no metastatic disease, and no history of inflammatory bowel disease or hip replacements.

Inclusion Criteria

I am fully active or can carry out light work.
I have no other diseases that could affect this cancer treatment's safety or results.
Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
See 3 more

Exclusion Criteria

MRI Prostate Volume greater than 80 cc
I have a history of inflammatory bowel disease.
I have had one or both of my hips replaced.
See 5 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 5 or 2 MRI-guided adaptive radiotherapy treatments for prostate cancer

1-2 weeks
2 or 5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple intervals

60 months
Regular follow-up visits at 3, 6, 12, 24, and 60 months

Treatment Details

Interventions

  • Radiation Therapy (Radiation Therapy)
Trial OverviewThe study compares two different schedules of MRI-guided adaptive radiotherapy treatments for prostate cancer: one group will receive five treatments while the other group will receive just two. The goal is to see which treatment schedule works best.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: 5 radiation treatments - ARM 1Experimental Treatment1 Intervention
Patients randomized to ARM 1 will receive 37.5 in 5 radiotherapy treatments.
Group II: 2 radiation treatments - ARM 2Active Control1 Intervention
Patients randomized to ARM 2 will receive 25 Gy in 2 radiotherapy treatments.

Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

🇨🇦
Approved in Canada as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇯🇵
Approved in Japan as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇳
Approved in China as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇭
Approved in Switzerland as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+
Dr. Robert Min profile image

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher profile image

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

Progenics Pharmaceuticals, Inc.

Industry Sponsor

Trials
35
Recruited
4,400+

Viewray Inc.

Industry Sponsor

Trials
13
Recruited
1,100+

Findings from Research

Intensity-modulated radiation therapy (IMRT) significantly reduces the mean dose and volume of radiation received by the rectum and bladder compared to 3-dimensional conformal radiation therapy (3DCRT), which is crucial for minimizing side effects in prostate cancer treatment.
IMRT allows for dose escalation up to 72.0 Gy while maintaining similar safety profiles for the bladder and rectum compared to 3DCRT at 68.4 Gy, suggesting potential for improved treatment efficacy without increasing toxicity.
Potential for dose escalation in the postprostatectomy setting with intensity-modulated radiation therapy: a dosimetric study using EORTC consensus guidelines for target volume contours.Harrison, A., Studenski, M., Harvey, A., et al.[2016]
Prostate cancer cells exhibit high levels of autophagy, indicated by high LC3A and low LAMP2a levels, which are associated with poorer outcomes in patients treated with radical radiotherapy.
Blocking components of the autophagy pathway can increase the sensitivity of prostate cancer cells to radiation, suggesting that targeting autophagy may enhance the effectiveness of radiotherapy in high-risk patients.
Intensified autophagy compromises the efficacy of radiotherapy against prostate cancer.Koukourakis, MI., Kalamida, D., Mitrakas, A., et al.[2022]
In a study of 192 patients with localized prostate cancer, using prostate-based IGRT (P-IGRT) resulted in significantly lower acute gastrointestinal toxicities compared to bony structure-based IGRT (B-IGRT), with rates of 3% versus 11%.
Both P-IGRT and B-IGRT showed similar prostate-specific antigen failure-free survival rates at 3 years (95.5% for P-IGRT and 92.7% for B-IGRT), indicating that P-IGRT can reduce toxicity without compromising tumor control.
Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance.Nakamura, K., Mizowaki, T., Inokuchi, H., et al.[2018]

References

Contemporary issues in radiotherapy for clinically localized prostate cancer. [2013]
Improved toxicity profile following high-dose postprostatectomy salvage radiation therapy with intensity-modulated radiation therapy. [2022]
[The role of radiotherapy in locally limited prostate cancer]. [2006]
Potential for dose escalation in the postprostatectomy setting with intensity-modulated radiation therapy: a dosimetric study using EORTC consensus guidelines for target volume contours. [2016]
Intensified autophagy compromises the efficacy of radiotherapy against prostate cancer. [2022]
Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. [2018]
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. [2021]
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]
Toxicity after intensity-modulated, image-guided radiotherapy for prostate cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
A comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or (125)I permanent implant. [2022]
[Radiotherapy in prostate cancer]. [2021]
12.Czech Republicpubmed.ncbi.nlm.nih.gov
[Radical radiotherapy of prostate carcinoma]. [2006]
[What is the level of evidence of new techniques in prostate cancer radiotherapy?]. [2018]
[Localized prostate cancer: Radiotherapeutic concepts]. [2018]