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Back|NCT05053152Recruiting
Official Title

A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

Phase
Phase 2
Sponsor
NRG Oncology
Enrollment
194
Timeline
Apr 2022 → Feb 2029
About This Study

This phase II trial compares the usual treatment of radiation therapy alone to using the study drug, relugolix, plus the usual radiation therapy in patients with castration-sensitive prostate cancer that has spread to limited other parts of the body (oligometastatic). Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. It may stop the growth of cancer cells that need testosterone to grow. Radiation therapy uses high-energy x rays or protons to kill tumor cells. The addition of relugolix to the radiation may reduce the chance of oligometastatic prostate cancer spreading further.

Eligibility Criteria

Inclusion Criteria

  • 1Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration
  • 2Age \>= 18 years
  • 3Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 180 days prior to registration
  • 4Prior curative-intent treatment to the prostate, by either:
  • 5External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites
  • 6Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
  • 7Note: Patients who have received curative intent with radiation prior to prostatectomy are eligible and should be categorized as RT to Intact Prostate since that was the first curative intent
  • 8Must meet study entry criteria based on the following diagnostic workup within 120 days prior to registration:
  • 9History and physical examination;
  • 10Fluciclovine or PSMA PET scan;
  • 11PET must be combined with either CT or MRI, but a diagnostic CT or MRI reading/interpretation is not required
  • 121 - 5 oligometastatic lesions in bone and/or nodal/soft tissue (non-abutting nodes are counted separately) sites on fluciclovine or PSMA PET within 180 days prior to registration and includes at least ONE of the following:
  • 13Bone - each metastasis is counted (for example, 2 distinct lesions in the right ilium count as 2 oligometastatic lesions)
  • 14Extrapelvic Nodal/ soft tissue - requires at least one extrapelvic inguinal or a nodal/soft tissue lesion superior to the iliac bifurcation (that is, American Joint Committee on Cancer \[AJCC\] M1a version 8)
  • 15Note: Although a patient must have bone and/or extrapelvic disease to be eligible, when counting the number of oligometastatic lesions, each lymph node lesion, whether pelvic or extrapelvic, is counted (for example, 2 distinct lymph nodes in the right external iliac basin count as 2 oligometastatic lesions; one extrapelvic and one pelvic node count as 2 oligometastic lesions, etc)
  • 16Serum total prostate-specific antigen (PSA) =\< 10.0 ng/mL that also meets ONE of the following PSA recurrence definitions:
  • 17If patient has received-radiation therapy to intact prostate, either
  • 18PSA \> post-RT nadir PSA + 2 ng/mL obtained within 180 days prior to registration, or
  • 19PSA \> 0.2 ng/mL with at least two rises from post-treatment nadir with the most recent PSA within 180 days prior to registration
  • 20If patient has received a radical prostatectomy with or without post-op RT, either
  • 21Current PSA \> 0.2 ng/mL, with a second confirmatory PSA \> 0.2 ng/mL, with most recent PSA obtained within 180 days prior to registration, or
  • 22Two consecutive PSA rises from post-operative nadir, with most recent PSA obtained within 180 days prior to registration
  • 23Must have \>= 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less
  • 24Note: PSA doubling time must be calculated by entering all PSA values since end of primary treatment or within the last 2 years prior to registration (whichever is less) into the PSA Doubling Time Calculator found at MDCalc.com
  • 25Serum total testosterone \>= 100 ng/dL within 180 days prior to registration
  • 26Note: Prior androgen deprivation therapy (other than bilateral orchiectomy) is allowed if discontinued prior to registration and serum total testosterone is \>= 100 ng/dL
  • 27Total bilirubin: =\< 1.5 x institutional upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, subject is eligible if direct bilirubin is =\< 1.5 x ULN) (within 180 days prior to registration)
  • 28Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): =\< 2.5 x institutional ULN (within 180 days prior to registration)
  • 29For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • 30Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
  • 31Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • 32Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
  • 33Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • 34The patient must agree to use a highly effective contraception (even men with vasectomies) if he is having sex with a woman of childbearing potential or with a woman who is pregnant while on study drug and for 2 weeks following the last dose of study drug
  • 35The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Exclusion Criteria

  • 1Currently on androgen deprivation or anti-androgen therapy
  • 2Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, etc.) metastasis
  • 3Note: Spinal metastases (PET-detected) with epidural extension are eligible if there is \> 0.3 cm spatial separation between the gross tumor volume and spinal cord. Lung metastases are eligible
  • 4Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell)
  • 5Prior metastatic or non-metastatic, invasive malignancy (except non metastatic, non-melanomatous skin cancer) unless continuously disease free for \>= 3 years
  • 6Prior chemotherapy for prostate cancer or bilateral orchiectomy
  • 7Note: Prior chemotherapy for a different cancer is allowed if continuously disease-free for \>= 3 years
  • 8Prior high dose radiotherapy to a lesion (i.e. oligometastatic recurrence by PET)
  • 9Note: Lesions included in or near a previously irradiated planning target volume (PTV) are eligible as long as previous delivered dose is estimated to be less than an EQD2 of 50 Gy
  • 10Inability to treat all oligometastatic sites with radiotherapy in the judgement of the investigator
  • 11Intrapelvic lymph nodes as only site of prostate cancer recurrence
  • 12Inability to swallow whole, undivided, unchewed, and uncrushed pills
  • 13Known gastrointestinal disorder affecting oral medication absorption
  • 14Co-morbidity defined as follows:
  • 15Patients with any comorbidities that would prohibit completion of protocol specified therapy
  • 16Inflammatory bowel disease in patients in whom abdominopelvic radiotherapy is planned
  • 17History of congenital long QT syndrome
  • 18Current severe or unstable angina
  • 19New York Heart Association functional classification III/IV heart failure (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification)

Locations

235 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Sheela Hanasoge

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Sheela Hanasoge

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

Recruiting

Sheela Hanasoge

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →