Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Ductal Adenocarcinoma, Prostate Intraductal Carcinoma, Stage IVB Prostate Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT05053152

Run by

NRG Oncology

People needed

194

Starts

2022-04-20

Expected to finish

2029-02-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically (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
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 180 days prior to registration
• Prior curative-intent treatment to the prostate, by either:
• External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites
• Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
• Note: 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
• Must meet study entry criteria based on the following diagnostic workup within 120 days prior to registration:
• History and physical examination;
• Fluciclovine or PSMA PET scan;
• PET must be combined with either CT or MRI, but a diagnostic CT or MRI reading/interpretation is not required
• 1 - 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:
• Bone - each metastasis is counted (for example, 2 distinct lesions in the right ilium count as 2 oligometastatic lesions)
• Extrapelvic 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)
• Note: 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)
• Serum total prostate-specific antigen (PSA) =< 10.0 ng/mL that also meets ONE of the following PSA recurrence definitions:
• If patient has received-radiation therapy to intact prostate, either
• PSA > post-RT nadir PSA + 2 ng/mL obtained within 180 days prior to registration, or
• PSA > 0.2 ng/mL with at least two rises from post-treatment nadir with the most recent PSA within 180 days prior to registration
• If patient has received a radical prostatectomy with or without post-op RT, either
• Current 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
• Two consecutive PSA rises from post-operative nadir, with most recent PSA obtained within 180 days prior to registration
• Must 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
• Note: 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
• Serum total testosterone >= 100 ng/dL within 180 days prior to registration

You may not qualify if…

• Currently on androgen deprivation or anti-androgen therapy
• Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, etc.) metastasis
• Note: 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
• Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell)
• Prior metastatic or non-metastatic, invasive malignancy (except non metastatic, non-melanomatous skin cancer) unless continuously disease free for >= 3 years
• Prior chemotherapy for prostate cancer or bilateral orchiectomy
• Note: Prior chemotherapy for a different cancer is allowed if continuously disease-free for >= 3 years
• Prior high dose radiotherapy to a lesion (i.e. oligometastatic recurrence by PET)
• Note: 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
• Inability to treat all oligometastatic sites with radiotherapy in the judgement of the investigator
• Intrapelvic lymph nodes as only site of prostate cancer recurrence
• Inability to swallow whole, undivided, unchewed, and uncrushed pills
• Known gastrointestinal disorder affecting oral medication absorption
• Co-morbidity defined as follows:
• Patients with any comorbidities that would prohibit completion of protocol specified therapy
• Inflammatory bowel disease in patients in whom abdominopelvic radiotherapy is planned
• History of congenital long QT syndrome
• Current severe or unstable angina
• New 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)

Where it is running

• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States
• Marin General Hospital — Greenbrae, California, United States
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Memorial Medical Center — Modesto, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• Sutter Pacific Medical Foundation — Santa Rosa, California, United States
• Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States
• UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States
• Memorial Hospital North — Colorado Springs, Colorado, United States
• AdventHealth Porter — Denver, Colorado, United States
• Shaw Cancer Center — Edwards, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado, United States
• Banner North Colorado Medical Center — Greeley, Colorado, United States
• UCHealth Greeley Hospital — Greeley, Colorado, United States
• UCHealth Highlands Ranch Hospital — Highlands Ranch, Colorado, United States
• Mary Bird Perkins Cancer Center - Metairie — Metairie, Louisiana, United States

Full record on ClinicalTrials.gov

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