Comparing two types of radiation therapy for prostate cancer recurrence after surgery

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 investigates the effectiveness of hypofractionated, accelerated high dose radiation therapy compared to standard radiation therapy in patients who have experienced biochemical recurrence of prostate cancer following radical prostatectomy. Participants will be randomly assigned to receive either 65 Gy in 26 fractions or 66 Gy in 33 fractions of radiation. The study aims to determine which treatment offers better biochemical control and to assess the associated toxicity and quality of life for patients. Stratification factors include risk groups, androgen deprivation therapy, and PSA levels prior to treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically confirmed intermediate- or high-risk prostate cancer
* Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and \<=1.0 ng/mL)
* ECOG performance status 0-1
* Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl
* Appropriate values of kidney function within 6 months after enrollment Creatinine \< 2.0 ng/dL
* Appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value

Exclusion Criteria:

* Clinically gross recurrent tumor
* Presence of distant metastasis
* Presence of pelvic LN metastasis
* History of pelvic irradiation
* History of cryotherapy or brachytherapy for prostate cancer
* Double primary cancer other than skin/thyroid cancer
* Combined serious morbidity

Where it's running

• Asan Medical Center
  Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Young Seok Kim, M.D., Ph.D. — Asan Medical Center
• Study coordinator: Young Seok Kim, M.D., Ph.D.
• Email: ysk@amc.seoul.kr
• Phone: 82 2 3010 5614

Similar studies

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

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  Recruiting Phase 2 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu and 1 other locations · NCT05753566

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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.