Comparing two versus five sessions of radiation therapy for localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare two different schedules of stereotactic radiation therapy for patients with localized prostate cancer. It evaluates the effectiveness and safety of delivering the same total radiation dose in just two sessions versus the standard five sessions. The study utilizes advanced imaging and technology to minimize side effects to surrounding organs by employing a hydrogel spacer. The goal is to determine if fewer treatment sessions can maintain efficacy while improving patient comfort and resource utilization.

Why it matters

Who can join: the full rules

Inclusion:

* Male patients ≥18 years
* Diagnosis of low- or favorable intermediate-risk prostate adenocarcinoma

  * T1-T2c
  * Prostate specific antigen \< 20
  * Gleason 6 or 7 (3+4)
  * Cannot had multiple intermediate-risk factors consistent with unfavorable intermediate risk disease
* Prostate gland \< 60 cc (can include following cytoreductive androgen deprivation)
* International Prostate Symptom Score \< 15 (unaided by a-adrenergic inhibitor or anticholinergic drugs)

Exclusion:

* Unfavorable intermediate-risk disease and above
* Chronic inflammatory bowel condition (IBD, Crohn's disease, Sarcoidosis, Rheumatic disease)
* Chronic immunosuppression
* Contraindications to hydrogel spacer placement
* Contraindications to a prostate MRI
* Any prior prostate cancer treatment
* Prior pelvic radiotherapy
* Previous transurethral resection of the prostate (TURP) within 12 months
* Hip prosthesis
* Prior use of therapeutic androgen deprivation therapy

Where it's running

• Davidoff Cancer Center, Rabin Medical Center
  Petah Tikva, Israel, Israel Recruiting

Study contacts

• Principal investigator: Elisha T Fredman, MD — Davidoff Cancer Center, Rabin Medical Center
• Study coordinator: Elisha T Fredman, MD
• Email: elishafre@clalit.org.il
• Phone: 9148744461

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.