Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy

This purpose of this study is to evaluate the safety and effectiveness of a technique called focal high-dose-rate (HDR) brachytherapy as treatment for prostate cancer that has come back in the prostate after prior radiotherapy. The study will examine the safety and efficacy of the treatment. The type of radiation that participants in this research will receive is targeted directly at the areas of the prostate where recurrent disease is evident, while avoiding treatment of the normal appearing prostate. This involves the placement of a radioactive material in the affected area of the prostate temporarily, where it remains for a short period of time, and then is subsequently removed using a minimally invasive technique called HDR Brachytherapy.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

* Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer.

  * Biopsy must be performed within 182 days of trial registration
  * Biopsy should be a standard sextant biopsy AND either a targeted MR/ultrasound guided biopsy or saturation biopsy or both.
* Initial cancer diagnosis that fits these specific criteria:

  * Stages T1-T3a
  * Nx or N0
  * Mx or M0
* Eligible initial definitive radiotherapy modalities include:
* External beam radiotherapy, with photon or proton beam therapy

  * Conventional or moderately hypofractionated radiotherapy
  * Extremely hypofractionated external beam radiotherapy (Stereotactic body radiation therapy)
* Definitive Brachytherapy:

  * Low-dose rate
  * High-dose rate
* Locally recurrent disease confined to the prostate +/- seminal vesicles and immediately adjacent tissue, as evaluated by the following:

  * History/Physical examination
  * Radiographically node negative disease (N0), as defined by CT or MR of pelvis +/- abdomen within 6 months of registration.
  * No evidence of bone metastases (M0) on bone scan within 6 months of registration.
  * Fluciclovine-PET is encouraged, but not required
* Patients receiving ADT are eligible as long as they meet the other eligibility criteria. However, the duration of all ADT must be documented.
* Current ECOG Performance status Scale 0-2
* Current International Prostate Symptom Score (IPSS) \< 20
* The patient must be medically suitable to receive general anesthesia.
* The patient must be able and willing to sign a study-specific written informed consent form before study entry.

Exclusion Criteria:

* Preregistration GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy
* Patients receiving any other investigational agents.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements.
* Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT

• BACKGROUNDParekh A, Graham PL, Nguyen PL. Cancer control and complications of salvage local therapy after failure of radiotherapy for prostate cancer: a systematic review. Semin Radiat Oncol. 2013 Jul;23(3):222-34. doi: 10.1016/j.semradonc.2013.01.006. PMID 23763889
• BACKGROUNDShipley WU, Thames HD, Sandler HM, Hanks GE, Zietman AL, Perez CA, Kuban DA, Hancock SL, Smith CD. Radiation therapy for clinically localized prostate cancer: a multi-institutional pooled analysis. JAMA. 1999 May 5;281(17):1598-604. doi: 10.1001/jama.281.17.1598. PMID 10235152
• BACKGROUNDZelefsky MJ, Kuban DA, Levy LB, Potters L, Beyer DC, Blasko JC, Moran BJ, Ciezki JP, Zietman AL, Pisansky TM, Elshaikh M, Horwitz EM. Multi-institutional analysis of long-term outcome for stages T1-T2 prostate cancer treated with permanent seed implantation. Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):327-33. doi: 10.1016/j.ijrobp.2006.08.056. Epub 2006 Nov 2. PMID 17084558
• BACKGROUNDZumsteg ZS, Spratt DE, Romesser PB, Pei X, Zhang Z, Kollmeier M, McBride S, Yamada Y, Zelefsky MJ. Anatomical Patterns of Recurrence Following Biochemical Relapse in the Dose Escalation Era of External Beam Radiotherapy for Prostate Cancer. J Urol. 2015 Dec;194(6):1624-30. doi: 10.1016/j.juro.2015.06.100. Epub 2015 Jul 10. PMID 26165583
• BACKGROUNDAhmadi H, Daneshmand S. Androgen deprivation therapy for prostate cancer: long-term safety and patient outcomes. Patient Relat Outcome Meas. 2014 Jul 5;5:63-70. doi: 10.2147/PROM.S52788. eCollection 2014. PMID 25045284
• BACKGROUNDWirth MP, Hakenberg OW, Froehner M. Antiandrogens in the treatment of prostate cancer. Eur Urol. 2007 Feb;51(2):306-13; discussion 314. doi: 10.1016/j.eururo.2006.08.043. Epub 2006 Sep 11. PMID 17007995
• BACKGROUNDGrado GL, Collins JM, Kriegshauser JS, Balch CS, Grado MM, Swanson GP, Larson TR, Wilkes MM, Navickis RJ. Salvage brachytherapy for localized prostate cancer after radiotherapy failure. Urology. 1999 Jan;53(1):2-10. doi: 10.1016/s0090-4295(98)00492-0.