Radiation Therapy for Prostate Cancer (FORT Trial)
Palo Alto (17 mi)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
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.
What safety data is available for radiation therapy in prostate cancer treatment?The safety data for radiation therapy in prostate cancer treatment includes several studies evaluating different techniques. A study on salvage radiotherapy (SRT) after radical prostatectomy using intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) reported late grade 2 or higher gastrointestinal (GI) and genitourinary (GU) toxicities at 4.8% and 24%, respectively. Another study found decreased acute toxicities with prostate-based IGRT compared to bone-based IGRT in localized prostate cancer. Additionally, image-guided intensity-modulated radiotherapy (IG-IMRT) showed improved toxicity profiles compared to 3D conformal radiotherapy (3DCRT) without daily image guidance in high-risk prostate cancer. Overall, advanced techniques like IMRT and IGRT are associated with reduced toxicity in prostate cancer treatment.3581213
Is Radiation Therapy a promising treatment for Prostate Cancer?Yes, Radiation Therapy is a promising treatment for Prostate Cancer. It is effective at almost any stage of the disease and can be as effective as surgery when applied with the right dose. New techniques like Intensity-Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT) allow for higher doses with fewer side effects, making the treatment even more valuable. It can also be combined with other treatments to improve outcomes.2491014
What data supports the idea that Radiation Therapy for Prostate Cancer is an effective treatment?The available research shows that Radiation Therapy, including advanced techniques like Intensity-modulated radiation therapy (IMRT) and Image-guided radiotherapy (IGRT), is an effective treatment for prostate cancer. It is considered a valid alternative to surgery, especially for patients with localized prostate cancer. Studies indicate that dose-escalated radiation improves patient outcomes, and postprostatectomy radiotherapy enhances long-term results for those at high risk of recurrence. Additionally, these techniques aim to improve local control of the cancer while preserving bladder and sexual function. Although not all patients respond to radiation therapy, ongoing research is helping to identify which tumors are more likely to benefit from this treatment.167911
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients with other diseases whose treatment does not interfere with the trial are eligible, so it's best to discuss your specific medications with the trial team.
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 can undergo MRI-guided radiotherapy.
I am a man over 18 with low or intermediate risk prostate cancer.
Exclusion Criteria
I have a history of inflammatory bowel disease.
I have had one or both of my hips replaced.
My cancer is more advanced than stage T3a according to MRI.
I have had a narrowing of my bladder neck or urethra.
My scans show cancer has spread to distant areas or pelvic nodes.
I have had radiation therapy to my pelvic area before.
Treatment Details
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.
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 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 nearbySelect from list below to view details:
Weill Cornell MedicineNew York, NY
Loading ...
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
Progenics Pharmaceuticals, Inc.Industry Sponsor
Viewray Inc.Industry Sponsor
References
[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.
[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.
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.
[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.
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.
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.
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.
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).
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.
[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.
[Prostate cancer: what treatment techniques for which tumors? Ethical and methodological issues]. [2018]The identification of the optimal radiation technique in prostate cancer is based on the results of dosimetric and clinical studies, although there are almost no randomized studies comparing different radiation techniques. The feasibility of the techniques depends also on the technical and human resources of the radiation department, on the cost of the treatment from the points of view of the society, the patient and the radiation oncologist, and finally on the choice of the patient. The slow evolution of prostate cancer leads to consider the biochemical failure as the main judgment criteria in the majority of the studies. A proper urinary radio-induced toxicity evaluation implies a long follow-up. Intensity-modulated radiotherapy (IMRT) combined with image-guided radiotherapy (IGRT) is recommended in case of high dose (≥76Gy) to the prostate, pelvic lymph nodes irradiation and hypofractionation schedules. For low-risk tumors, the aim of the treatment is to preserve quality of life, while limiting costs. Stereotactic body radiotherapy shows promising results, although the follow-up is still limited and phase III trials are ongoing. Focal radiation techniques are in the step of feasibility. For intermediate and high-risk tumors, the objective of the treatment is to increase the locoregional control, while limiting the toxicity. IMRT combined with IGRT leads to either a well-validated dose escalation strategy for intermediate risk tumors, or to a strategy of moderate hypofractionated schedules, which cannot be yet considered as a standard treatment. These combined radiation techniques allow finally large lymph node target volume irradiation and dose escalation potentially in the dominant intraprostatic lesion. The feasibility of simultaneous integrated boost approaches is demonstrated.
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).
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
RADIOTHERAPY OF PROSTATE CANCER: PRIMARY RADIOTHERAPY AND RADIOTHERAPY IN DISEASE RELAPSE. [2022]Radiotherapy presents one of the essential modes of treatment in patients with prostate cancer at almost any stage of the disease. It can be delivered as external beam radiotherapy, as brachytherapy or two methods combined. Higher radiation doses are proven to be more effective than low doses and moderate hypofractionation with doses up to 3.4 Gy per fraction is proven equivalent to standard fractionation using 1.8- 2 Gy per fraction. Stereotactic body radiotherapy (SBRT) with doses from 3.4 to 7.25 Gy per fraction presents valuable option in certain subgroups of patients. In case of local regional disease relapse, radiotherapy is used in curative setting.