Personalized two-fraction radiation for 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 Phase 2 trial investigates a personalized radiotherapy approach in men with intermediate or high-risk prostate cancer. Using MRI to monitor tumor response, the plan is to deliver a second higher-dose radiation to prostate nodules that responded to the first fraction. The first fraction adds dose to identifiable nodules, and the second fraction tailors subsequent dosing based on observed response. The study aims to determine safety and feasibility of this adaptive, two-fraction strategy with SBRT-appropriate patients. Enrollment is limited to patients with MRI-detected PIRADS 4-5 nodules who have not had prior pelvic radiotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* NCCN risk grouping of intermediate or high risk prostate cancer
* Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent/assent
* Identifiable lesion within the epithelium of the prostate as determined by the treating radiation oncologist
* Have a prostate imaging reporting and data system (PIRADS) 4 or 5 nodule noted on MRI
* Have not received prior pelvic radiotherapy
* Life expectancy greater than 10 years
* ECOG performance status \<3
* Eligible for SBRT to the prostate

Exclusion Criteria:

* No identifiable lesion within the prostate on 3T MRI
* Prior trans-urethral resection of the prostate
* Non-adenocarcinoma histology
* Meeting criteria for very high-risk risk or node positive prostate cancer
* Active inflammatory bowel disease
* Evidence of metastatic disease on CT or bone scan
* Declined radiotherapy
* Unlikely to be available for all follow-up appointments
* Having received androgen deprivation therapy or 5-alpha reductase therapy prior to trial therapy
* Extensive disease in the posterior prostate or aberrant anatomy that makes the safe delivery of boost irradiation not feasible
* Unable to understand or sign a study consent form after use of interpreter if required
* Has a relative contraindication to radiotherapy including systemic lupus erythematosus, TNM deficiency or scleroderma
* Unable to tolerate or ineligible for mpMR imaging
* Any condition or diagnosis, that could in the opinion of the treating physician or qualified investigator interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk

Where it's running

• Jack Ady Cancer Centre
  Lethbridge, Alberta, Canada Recruiting

Study contacts

• Study coordinator: Charlie Kirkby
• Email: Charles.Kirkby@cancercarealberta.ca
• Phone: 403-388-6872

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

• PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer

  This study tests whether PSMA-guided surgery can help identify and study tissue-resident T cells in prostate cancer that has spread to lymph nodes.

  Recruiting Niguarda Hospital · Milan, Lombardy · NCT07879820

• Predictive factors for response to Lu-177 PSMA therapy in metastatic castration-resistant prostate cancer

  This study tests whether imaging, dose measurements, and blood tests can predict which men with metastatic castration-resistant prostate cancer will respond to Lu-177 PSMA therapy.

  Recruiting Lithuanian University of Health Sciences · Kaunas · NCT07863986

• Salvage high-dose-rate brachytherapy for locally recurrent prostate cancer

  This observational study tests whether salvage HDR brachytherapy can help men with locally recurrent prostate cancer after initial radiotherapy, using advanced imaging and biopsy to guide treatment.

  Recruiting at 8 sites Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic · Benidorm, Alicante and 9 other locations · NCT07860528

• Multi-peptide Vaccination and PSMAxCD3 Antibody Therapy for Prostate Cancer with Biochemical Recurrence

  This phase 2 trial tests whether a PSMA-targeted bispecific antibody (CC-1), a prostate cancer peptide vaccine (VAC-XS15-PC01), or both can be given safely and help control biochemical recurrence after local therapy in men with prostate cancer.

  Recruiting Phase 2 University Hospital Tuebingen · Heidelberg, Baden-Wurttemberg and 3 other locations · NCT07860047

• Lutetium-177 Ludotadipep for advanced prostate cancer

  This study tests whether adding Lu-177 Ludotadipep to standard care helps men with metastatic castration-resistant prostate cancer live longer without their disease getting worse.

  Recruiting at 7 sites Phase 3 FutureChem · Gyeonggi-do and 7 other locations · NCT07853209

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.