Radiation therapy for recurrent 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 clinical trial aims to improve the control of prostate cancer by delivering radiation therapy specifically to the para-aortic and pelvic lymph nodes, combined with systemic androgen suppression therapy. The study will also focus on preserving the quality of life for patients after radiation treatment. Additionally, it will utilize imaging results from PSMA PET/CT scans to evaluate and manage disease progression effectively.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically proven prostate adenocarcinoma
2. Male, ≥ 18 years old
3. Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes

   * a. No more than a total of 5 lesions on PSMA PET/CT scan (each lesion defined as positive with standardized uptake value (SUV) \> liver uptake and CT scan correlate)
   * b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes
   * c. At least one lesion in the sub-diaphragmatic pelvic or para-aortic lymph nodes
   * d. Non-bulky nodal disease (ie, tumor \<5 cm)
4. Prior pelvic radiation with disease response

   * a. Definitive radiation therapy to the prostate with or without treatment of the pelvic lymph nodes and/or
   * b. Salvage or adjuvant radiation therapy to the prostate bed following prostatectomy with or without treatment of the pelvic lymph nodes
5. Hormone-sensitive prostate cancer
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
7. Ability to understand the investigational nature, potential risks and benefits of the research study, and willingness to sign the written informed consent and HIPAA document(s)
8. Willingness to fill out quality of life and psychosocial forms
9. Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)

Exclusion Criteria:

1. No pathological diagnosis of prostate adenocarcinoma
2. Patient has more than 5 sites of metastatic disease
3. Patient has history of bone and/or visceral metastasis
4. No evidence of disease in the para-aortic or pelvic lymph nodes
5. No staging with PSMA PET/CT scan
6. History of prior radiation therapy outside the pelvis for prostate cancer
7. Bulky nodal disease \>5 cm in tumor size
8. Androgen deprivation therapy (ADT) or chemotherapy in the three months prior to staging PSMA PET/CT scan (suggesting oligoprogressive disease, rather than true oligorecurrent disease) or at time of study enrollment
9. Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy
10. Implanted hardware which limits treatment planning or delivery (determined by treating physician)
11. Castration-resistant prostate cancer (history of rising PSA with serum testosterone level \<50 ng/dL)
12. Patients with ECOG performance status \> 2
13. History of inflammatory bowel disease
14. History of malignancy other than prostate cancer except for non-melanoma skin cancer
15. Patients unable to consent or are prisoners
16. Unwilling to fill out quality of life and psychosocial forms
17. Participants with impaired decision-making capacity

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Benjamin J Rich, MD — University of Miami
• Study coordinator: Benjamin J Rich, MD
• Email: brich@miami.edu
• Phone: 305-243-4200

Similar studies

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

• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

  This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• Lower-dose radiation to parts of the prostate for some men with prostate cancer

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• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

  This study tries adding rhPSMA-7.3 (flotufolastat F18) PET/CT to standard mpMRI to see if it finds higher-grade prostate cancer in men on active surveillance.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07285057

• Mevrometostat plus enzalutamide versus enzalutamide alone for men with metastatic castration‑sensitive prostate cancer who are ARPI‑naïve

  This trial will test whether adding the investigational drug mevrometostat to enzalutamide helps men with metastatic castration‑sensitive prostate cancer who have not received androgen receptor pathway inhibitors or chemotherapy.

  Recruiting at 145 sites Phase 3 Pfizer · Huntsville, Alabama and 318 other locations · NCT07028853

• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

  Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT06957691

• Two-fraction radiotherapy for localized prostate cancer

  This study is testing if giving radiotherapy in just two sessions instead of five can effectively treat localized prostate cancer while causing fewer side effects for patients.

  Recruiting UMC Utrecht · Utrecht · NCT06518226

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.