Prostate Cancer Clinical Trial

Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer

Summary

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.

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Full Description

This study is a randomized non-inferiority trial comparing 5 to 2 radiotherapy treatments using an MRI linear accelerator for men with low or intermediate-risk prostate cancer electing for definitive radiotherapy.

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Eligibility Criteria

Inclusion Criteria:

Men aged >=18 with histologically confirmed low or intermediate risk prostate cancer per NCCN guidelines.
ECOG 0 - 1
IPSS < 18
Ability to receive MRI-guided radiotherapy.
Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
Patients with a prior or concurrent disease whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the Principal Investigator.

Exclusion Criteria:

Prior history of receiving pelvic radiotherapy.
Patient with history of inflammatory bowel disease.
MRI Prostate Volume > 80 cc
MRI Stage > T3a
Unilateral or bilateral hip replacements.
History of bladder neck or urethral stricture.
TURP < 8 weeks prior to radiotherapy
Metastatic (pelvic nodal or distant) disease on CT, Bone, Fluciclovine, and/or PSMA PET scan

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

136

Study ID:

NCT04984343

Recruitment Status:

Recruiting

Sponsor:

Weill Medical College of Cornell University

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There is 1 Location for this study

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Weill Cornell Medicine
New York New York, 10065, United States More Info
Charles Ekeh, M.D
Contact
646-962-2196
[email protected]
Pragya Yadav, Ph.D.
Contact
646-962-2199
[email protected]
Himanshu Nagar, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

136

Study ID:

NCT04984343

Recruitment Status:

Recruiting

Sponsor:


Weill Medical College of Cornell University

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