Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    134
  • sponsor
    Weill Medical College of Cornell University
Updated on 11 July 2021
prostatectomy
metastasis
bone scan
hypofractionated radiation therapy

Summary

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. The investigators are also interested in looking at time to progression and the quality of life (health scores).

Description

The standard treatment for most patients with biochemical recurrence after radical prostatectomy is salvage radiotherapy. 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.

Patients are recommended to undergo salvage radiotherapy to eradicate biochemical disease delivered in approximately 40 treatments over the course of 8 weeks, representing a high burden of therapy, which may be related to lower utilization of salvage radiotherapy. Modern radiotherapy for prostate cancer 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 ultra-hypofractionated radiotherapy delivered over 20 or 5 treatments are: 1) increased convenience to patients because of fewer treatment days, 2) reduced costs to patients because of reduced travel expenses and copays, 3) improved resource utilization for physicians because of the fewer number of treatments per patient and consequently 4) 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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment 5 days Radiation Therapy (32.5 Gy in 5 fractions), 20 days Radiation therapy (55 Gy in 20 fractions)
Clinical Study IdentifierNCT04422132
SponsorWeill Medical College of Cornell University
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men aged 18 and older with histologically confirmed prostate cancer after prostatectomy with PSA of at least 0.1 ng/ml
Prostatectomy > 6 months before treatment
KPS > 70
Patient with no evidence of distant metastatic disease on CT/MRI and bone scan < 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 of ultra-hypofractionated radiotherapy
History of bladder neck or urethral stricture
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