Radiation Therapy for Prostate Cancer

(FORT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Himanshu 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{4 11 12 13 14}

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

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.

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 Overview The 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

Group I: 5 radiation treatments - ARM 1 Experimental Treatment 1 Intervention

Patients randomized to ARM 1 will receive 37.5 in 5 radiotherapy treatments.

Group II: 2 radiation treatments - ARM 2 Active Control 1 Intervention

Patients randomized to ARM 2 will receive 25 Gy in 2 radiotherapy treatments.

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

🇪🇺 Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

🇺🇸 Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

🇨🇦 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

Research Locations Nearby Select from list below to view details:

Weill Cornell Medicine New York, NY

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University Lead Sponsor

Progenics Pharmaceuticals, Inc. Industry Sponsor

Viewray Inc. Industry Sponsor

References

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

Contemporary issues in radiotherapy for clinically localized prostate cancer. [2013] Radiotherapy is a valid curative alternative to surgery for prostate cancer. However, patient selection is critical to ensure patients obtain benefits from therapy delivered with curative intent. Dose-escalated radiation has been shown to improve patient outcomes, facilitated by development of robust image guidance and better target delineation imaging technologies. These concepts have also rekindled interest in hypofractionated radiotherapy in the forms of stereotactic body radiotherapy and brachytherapy. Postprostatectomy radiotherapy also improves long-term biochemical outcome in men at high risk of local recurrence.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Improved toxicity profile following high-dose postprostatectomy salvage radiation therapy with intensity-modulated radiation therapy. [2022] With salvage radiation therapy (SRT) in the postprostatectomy setting, the need to deliver sufficient radiation doses to achieve a high probability of tumor control is balanced with the risk of increased toxicity. Intensity-modulated radiation therapy (IMRT) in the postprostatectomy salvage setting is gaining interest as a treatment strategy.

3. Germany pubmed.ncbi.nlm.nih.gov

[The role of radiotherapy in locally limited prostate cancer]. [2006] Radiation therapy is a legitimate option of treatment for patients with clinically localized prostate carcinoma. Local control of the primary neoplasm can be improved, since clinical and biopsy evidence of prostate cancer after radiation remains high. Improved megavoltage and interstitial radiation methods are being tested to improve local cure rates, preserve bladder and sexual function, and reduce morbidity. Not all patients respond to radiation therapy, and current investigation may help to distinguish those tumors that will respond versus those better treated by alternative means.

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

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] Radiation therapy (RT) is delivered as adjuvant and salvage therapy after radical prostatectomy for prostate cancer. Interest in dose escalation in this setting may necessitate more advanced RT techniques, such as intensity modulation. This study was designed to compare intensity-modulated radiation therapy (IMRT) versus 3-dimensional conformal radiation therapy (3DCRT) planning.

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

Intensified autophagy compromises the efficacy of radiotherapy against prostate cancer. [2022] Radiotherapy is an equivalent alternative or complement to radical prostatectomy, with high therapeutic efficacy. High risk patients, however, experience high relapse rates, so that research on radio-sensitization is the most evident route to improve curability of this common disease.

6. Japan pubmed.ncbi.nlm.nih.gov

Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. [2018] Intensity-modulated radiation therapy (IMRT) is a major therapeutic option for localized prostate cancer. Image-guided radiation therapy (IGRT) allows tumor visualization and corrects the errors caused by daily internal movement of the prostate. The current study retrospectively compared the acute toxicities and biochemical tumor control outcomes of prostate IMRT achieved using two IGRT techniques: bony structure-based IGRT (B-IGRT) and prostate-based IGRT (P-IGRT).

7. England 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. [2021] Image-guided radiotherapy (IGRT) facilitates the delivery of a very precise radiation dose. In this study we compare the toxicity and biochemical progression-free survival between patients treated with daily image-guided intensity-modulated radiotherapy (IG-IMRT) and 3D conformal radiotherapy (3DCRT) without daily image guidance for high risk prostate cancer (PCa).

8. England pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021] The safety and efficacy of dose-escalated radiotherapy with intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) remain unclear in salvage radiotherapy (SRT) after radical prostatectomy. We examined the impact of these advanced radiotherapy techniques and dose intensification on the toxicity of SRT. This multi-institutional retrospective study included 421 patients who underwent SRT at the median dose of 66 Gy in 2-Gy fractions. IMRT and IGRT were used for 225 (53%) and 321 (76%) patients, respectively. At the median follow-up of 50 months, the cumulative incidence of late grade 2 or higher gastrointestinal (GI) and genitourinary (GU) toxicities was 4.8% and 24%, respectively. Multivariate analysis revealed that the non-use of either IMRT or IGRT, or both (hazard ratio [HR] 3.1, 95% confidence interval [CI] 1.8-5.4, p

9. Germany pubmed.ncbi.nlm.nih.gov

Toxicity after intensity-modulated, image-guided radiotherapy for prostate cancer. [2022] :To evaluate toxicity after dose-escalated radiotherapy for prostate cancer using intensity-modulated treatment planning (IMRT) and image-guided treatment (IGRT) delivery.

10. United States pubmed.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] To compare the toxicity and biochemical outcomes of intensity-modulated radiation therapy (IMRT) and (125)I transperineal permanent prostate seed implant ((125)I) for patients with low-risk prostate cancer.

11. Germany pubmed.ncbi.nlm.nih.gov

[Radiotherapy in prostate cancer]. [2021] Radiotherapy is a well-accepted treatment modality for patients with localised prostate cancer. Provided that radiotherapy is applied with a sufficient radiation dose, it is as effective as radical prostatectomy. Different radiation modalities are available (interstitial brachytherapy, external beam radiotherapy or a combination of both). Various new developments will further increase the value of radiation-based approaches. In this regard, a wider use of intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) will result in higher treatment doses with even lower toxicity rates. Combinations of radiotherapy and hormonal ablation improve local control rates in defined groups of patients. After prostatectomy with positive surgical margins, adjuvant radiotherapy improves disease-free survival rates; in cases of local relapse, salvage radiotherapy is the only potentially curative treatment approach.

12. Czech Republic pubmed.ncbi.nlm.nih.gov

[Radical radiotherapy of prostate carcinoma]. [2006] Radiotherapy is an effective treatment modality of prostate carcinoma. Considering the limited radiosensitivity of this tumour it is necessary to use relatively high doses of radiation. Modern technology offers the possibility to perform high-dose radiotherapy with acceptable toxicity. The authors present various options of both external and internal irradiation. They point out that brachytherapy, previously considered less appropriate from the radiobiology aspect, is according to the current views and results a very suitable treatment modality of prostate cancer.

13. France pubmed.ncbi.nlm.nih.gov

[What is the level of evidence of new techniques in prostate cancer radiotherapy?]. [2018] Prostate cancer radiotherapy has evolved from the old 2D technique to conformal, and then to intensity-modulated radiation therapy (IMRT) and stereotactic radiotherapy. At the same time, image-guidance (IGRT) is routinely used. New techniques such as protontherapy or carbontherapy are being developed with the objective of increased efficacy, decreased treatment duration, toxicity or cost. This review summarizes the evidence-based medicine of new technologies in the treatment of prostate cancer.

14. Germany pubmed.ncbi.nlm.nih.gov

[Localized prostate cancer: Radiotherapeutic concepts]. [2018] Radiation therapy is an established cornerstone in the treatment of prostate cancer. Significant advances in the techniques and therapeutic concepts have been made in recent decades.