Prostate Cancer Clinical Trial
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer
Summary
This phase II trial tests whether relugolix and radiation therapy works to shrink tumors in patients with prostate cancer that has spread in a limited way to 1 to 5 other parts of the body (oligometastatic). Testosterone can cause the growth of prostate cancer cells. Relugolix lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Giving relugolix with radiation therapy may help lower the chance of prostate cancer growing or spreading.
Full Description
PRIMARY OBJECTIVE:
I. Compare conventional radiological progression-free survival (rPFS) for positron emission tomography (PET)-detected, biochemically recurrent, oligometastatic, castration-sensitive prostate cancer patients treated with stereotactic ablative body radiation therapy (SABR) plus placebo versus (vs.) SABR plus relugolix.
SECONDARY OBJECTIVES:
I. Compare conventional or PET-based radiological progression-free survival (prPFS) between treatment arms.
II. Compare patient-reported sexual and hormonal quality of life as assessed by corresponding Expanded Prostate Cancer Index Composite Short Form (EPIC-26) domains between treatment arms.
III. Compare other measures of quality of life obtained from the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ5D-5L), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-30), and Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instruments between the two treatment arms.
IV. Compare time to salvage therapy and time to castration-resistance between treatment arms.
V. Compare local progression (SABR-targeted lesion), biochemical progression, distant metastases, prostate cancer-specific mortality, metastasis-free survival, and overall survival between treatment arms.
VI. Determine adverse events rates and compare rates between the two treatment arms.
EXPLORATORY OBJECTIVE:
I. Evaluate genomic and peripheral tissue and blood markers of treatment response.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive placebo orally (PO) once daily (QD) on days 1-180 (three tablets on Day 1, one tablet daily on Days 2-180) and undergo SABR for 1-3 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive relugolix PO QD on days 1-180 (three tablets on Day 1, one tablet daily on Days 2-180) and undergo SABR for 1-3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 and 6 months, every 6 months for 4 years, and then annually thereafter.
Eligibility Criteria
Inclusion Criteria:
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 120 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
Must meet study entry criteria based on the following diagnostic workup within 120 days prior to registration:
History and physical examination;
Technetium TC-99m (99mTc) bone scan (Must be negative);
Either computed tomography (CT) or magnetic resonance imaging (MRI) of pelvis +/- abdomen (Must be negative);
Fluciclovine or prostate-specific membrane antigen (PSMA) PET scan (Must be positive with exception of local disease);
Note: All 3 scans are mandatory (bone scan; CT/magnetic resonance [MR]; PET)
1 - 5 oligometastatic lesions in bone and/or nodal/soft tissue sites on fluciclovine or PSMA PET within 120 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 obtained within 120 days prior to registration that also meets ONE of the following PSA recurrence definitions:
PSA ≥ post-radiation therapy (RT) nadir PSA + 2 ng/mL, if patient received-radiation therapy to intact prostate, or
Current PSA ≥ 0.2 ng/mL, with a second confirmatory PSA ≥ 0.2 ng/mL if patient received a radical prostatectomy with or without post-op RT
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 120 days prior to registration
Note: Prior androgen deprivation therapy (other than bilateral orchiectomy) is allowed if discontinued prior to registration and serum total testosterone is ≥ 100 ng/dL
Total 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 120 days prior to registration)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]): ≤ 2.5 x institutional ULN (within 120 days prior to registration)
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Note: 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)
Patients 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
Note: 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
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
The 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
The 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:
Clinical, biopsy-proven, or radiologic (conventional or PET imaging) evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy
Note: if a patient had a prior local recurrence and received local salvage therapy, the patient is eligible if there is no current evidence of disease in the prostate/prostate bed. Patients with positive findings on examination or imaging remain eligible if biopsy of the site is negative for cancer.
Currently on androgen deprivation or anti-androgen therapy
Definitive radiologic evidence of metastatic disease on conventional imaging, defined by one of the following:
Osseous metastasis on 99mTc radionuclide bone scan, or
Extra pelvic nodal/soft tissue disease (> 1.5 cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, 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.
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 radiotherapy to a lesion (i.e. oligometastatic recurrence by PET)
Note: Lesions outside of a previously irradiated planning treatment volume (PTV) are eligible as long as the prescription isovolume dose of any prior radiotherapy course is > 2.0 cm distant from new lesion
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)
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There are 121 Locations for this study
Phoenix Arizona, 85004, United States More Info
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Berkeley California, 94704, United States More Info
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Beverly Hills California, 90211, United States
Los Angeles California, 90033, United States More Info
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Los Angeles California, 90033, United States More Info
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Los Angeles California, 90048, United States More Info
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Orange California, 92868, United States More Info
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Aurora Colorado, 80045, United States More Info
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Boulder Colorado, 80304, United States More Info
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Colorado Springs Colorado, 80909, United States More Info
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Colorado Springs Colorado, 80920, United States More Info
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Fort Collins Colorado, 80524, United States More Info
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Fort Collins Colorado, 80528, United States More Info
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Greeley Colorado, 80631, United States More Info
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Highlands Ranch Colorado, 80129, United States More Info
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Loveland Colorado, 80538, United States More Info
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Frankford Delaware, 19945, United States More Info
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Newark Delaware, 19713, United States More Info
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Newark Delaware, 19713, United States More Info
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Rehoboth Beach Delaware, 19971, United States More Info
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Lakewood Ranch Florida, 34202, United States More Info
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Plantation Florida, 33324, United States More Info
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Atlanta Georgia, 30308, United States More Info
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Atlanta Georgia, 30309, United States More Info
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Atlanta Georgia, 30322, United States More Info
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Atlanta Georgia, 30342, United States More Info
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Fayetteville Georgia, 30214, United States More Info
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Decatur Illinois, 62526, United States More Info
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Effingham Illinois, 62401, United States More Info
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Peoria Illinois, 61636, United States More Info
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Peoria Illinois, 61637, United States More Info
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Springfield Illinois, 62781, United States More Info
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Fort Wayne Indiana, 46845, United States More Info
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Ames Iowa, 50010, United States More Info
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Ames Iowa, 50010, United States More Info
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Des Moines Iowa, 50309, United States More Info
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Metairie Louisiana, 70006, United States More Info
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Metairie Louisiana, 70006, United States More Info
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Ann Arbor Michigan, 48106, United States More Info
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Brighton Michigan, 48114, United States More Info
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Brighton Michigan, 48114, United States More Info
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Canton Michigan, 48188, United States More Info
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Canton Michigan, 48188, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Clarkston Michigan, 48346, United States More Info
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Farmington Hills Michigan, 48334, United States More Info
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Livonia Michigan, 48154, United States More Info
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Macomb Michigan, 48044, United States More Info
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Madison Heights Michigan, 48071, United States More Info
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Pontiac Michigan, 48341, United States More Info
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Royal Oak Michigan, 48073, United States More Info
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Troy Michigan, 48085, United States More Info
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Troy Michigan, 48098, United States More Info
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Ypsilanti Michigan, 48197, United States More Info
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Saint Paul Minnesota, 55101, United States More Info
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Cape Girardeau Missouri, 63703, United States More Info
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Lebanon New Hampshire, 03756, United States More Info
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Albuquerque New Mexico, 87102, United States More Info
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Buffalo New York, 14263, United States More Info
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Rochester New York, 14620, United States More Info
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Rochester New York, 14642, United States More Info
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Greenville North Carolina, 27834, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Avon Ohio, 44011, United States More Info
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Beachwood Ohio, 44122, United States More Info
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Cleveland Ohio, 44106, United States More Info
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Mentor Ohio, 44060, United States More Info
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Parma Ohio, 44129, United States More Info
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Ravenna Ohio, 44266, United States More Info
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Sylvania Ohio, 43560, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Portland Oregon, 97239, United States More Info
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Beaver Pennsylvania, 15009, United States More Info
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Bryn Mawr Pennsylvania, 19010, United States More Info
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Carlisle Pennsylvania, 17015, United States More Info
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Chadds Ford Pennsylvania, 19317, United States More Info
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Danville Pennsylvania, 17822, United States More Info
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East Norriton Pennsylvania, 19401, United States
Erie Pennsylvania, 16505, United States More Info
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Farrell Pennsylvania, 16121, United States More Info
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Furlong Pennsylvania, 18925, United States
Harrisburg Pennsylvania, 17109, United States More Info
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Lewisburg Pennsylvania, 17837, United States More Info
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Mechanicsburg Pennsylvania, 17050, United States More Info
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Media Pennsylvania, 19063, United States More Info
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Moon Pennsylvania, 15108, United States More Info
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Paoli Pennsylvania, 19301, United States More Info
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Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15213, United States More Info
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Pittsburgh Pennsylvania, 15232, United States More Info
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Pittsburgh Pennsylvania, 15232, United States More Info
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Pittsburgh Pennsylvania, 15237, United States More Info
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Pottsville Pennsylvania, 17901, United States More Info
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Seneca Pennsylvania, 16346, United States More Info
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Washington Pennsylvania, 15301, United States More Info
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Wilkes-Barre Pennsylvania, 18711, United States More Info
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Williamsport Pennsylvania, 17754, United States More Info
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Wynnewood Pennsylvania, 19096, United States More Info
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Myrtle Beach South Carolina, 29577, United States More Info
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Sioux Falls South Dakota, 57104, United States More Info
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Sioux Falls South Dakota, 57117, United States More Info
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Lubbock Texas, 79410, United States More Info
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Saint Johnsbury Vermont, 05819, United States More Info
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Huntington West Virginia, 25701, United States More Info
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Antigo Wisconsin, 54409, United States More Info
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Grafton Wisconsin, 53024, United States More Info
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Green Bay Wisconsin, 54311, United States More Info
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Marinette Wisconsin, 54143, United States More Info
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Marshfield Wisconsin, 54449, United States More Info
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Menomonee Falls Wisconsin, 53051, United States More Info
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Milwaukee Wisconsin, 53215, United States More Info
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Milwaukee Wisconsin, 53226, United States More Info
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Milwaukee Wisconsin, 53233, United States More Info
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Minocqua Wisconsin, 54548, United States More Info
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Mukwonago Wisconsin, 53149, United States More Info
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New Richmond Wisconsin, 54017, United States More Info
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Oak Creek Wisconsin, 53154, United States More Info
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Oconomowoc Wisconsin, 53066, United States More Info
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Oshkosh Wisconsin, 54904, United States More Info
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Sheboygan Wisconsin, 53081, United States More Info
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Stevens Point Wisconsin, 54481, United States More Info
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Summit Wisconsin, 53066, United States More Info
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Waukesha Wisconsin, 53188, United States More Info
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Wausau Wisconsin, 54401, United States More Info
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Wauwatosa Wisconsin, 53226, United States More Info
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West Allis Wisconsin, 53227, United States More Info
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West Bend Wisconsin, 53095, United States More Info
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Wisconsin Rapids Wisconsin, 54494, United States More Info
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