Pfizer COVID-19 vaccine appointments are available to our patients. Sign up for Connect today to schedule your vaccination.

Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer in 4 Weeks v. 2 Weeks (SHORTER)

Clinical Trial Details

The purpose of this study is to compare urinary and bowel side effects of hypofractionated radiotherapy in 20 treatments (4 weeks) to ultra- hypofractionated radiotherapy in 5 treatments (2 weeks) for prostate cancer that has returned after prostatectomy.

Learn more about the trial details in this informational video:

Total numerical dose differs in each arm but is considered biologically equivalent to each other and protracted fractionated radiotherapy (8 weeks).The investigators are also interested in looking at progression-free survival and the quality of life (health scores). The standard treatment for men with detectable PSA (biochemical recurrence) after radical prostatectomy is salvage radiotherapy (radiation after detectable PSA). Salvage radiotherapy delays the need for chronic, non-curative treatment, such as long-term androgen suppression, and is the only potentially curative treatment of some biochemical recurrences after prostatectomy. Standard treatment regimens range from 20-40 treatments.

Patients are recommended to undergo salvage radiotherapy delivered over many weeks, representing a high burden of therapy. Modern radiotherapy has been afforded many advantages including advanced image-guided radiotherapy allowing for larger dose delivery in fewer treatments and smaller margins with hypofractionated (20 treatments) and ultra-hypofractionated (5 treatments) radiotherapy. In patients that need salvage radiotherapy, the potential advantages of hypofractionated and ultrahypofractionated radiotherapy delivered over 20 or 5 treatments are: 

  • increased convenience to patients because of fewer treatment days
  • reduced costs to patients because of reduced travel expenses and copays
  • improved resource utilization for physicians because of the fewer number of treatments per patient and consequently
  • reduced cost to society. In prostate cancer specifically, hypofractionated and ultra-hypofractionated radiotherapy has the added potential of not increasing toxicity with shorter treatment times.
Key Eligibility: 

Inclusion Criteria

  • Men aged ≥18 with histologically confirmed prostate cancer after prostatectomy with detectable PSA. PSA does not need to be detectable for men with pathologically node positive disease.
  • Prostatectomy greater than 6 months before treatment
  • KPS greater than or equal to 70
  • Patient with no evidence of distant metastatic disease on CT/MRI and bone scan less than 60 days prior to enrollment. Patients with pelvic lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm in the short axis.
  • Ability to receive MRI-guided radiotherapy
  • Equivocal evidence of metastatic disease outside the pelvis on standard imaging requires documented negative biopsy
  • Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

Exclusion Criteria

  • Prior history of receiving pelvic radiotherapy
  • Patient with inflammatory bowel disease
  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment
  • History of bladder neck or urethral stricture

Study contact by location

Upper East Side - Manhattan

Contact(s)

Sharanya Chandrasekhar
(646) 962-2196
shc2043@med.cornell.edu

Pragya Yadav
(646) 962-2199
pry2003@med.cornell.edu

Jessica Richman
(646) 962-3118
jbr4003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2003021572

ClinicalTrials.gov:

NCT04422132

Status

Open to Enrollment

Age Group

Adult

Sponsor