Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Conditions

• Prostate Adenocarcinoma

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bicalutamide — DRUG
  Drug
• Buserelin — DRUG
  Drug
• Darolutamide — DRUG
  Given PO
• Degarelix — DRUG
  Drug
• Flutamide — DRUG
  Drug
• Goserelin — DRUG
  Drug
• Histrelin — DRUG
  Drug
• Leuprolide — DRUG
  Drug
• Radiation Therapy — RADIATION
  Undergo RT
• Relugolix — DRUG
  Drug
• Triptorelin — DRUG
  Drug

Study Details

This phase III trial uses the Decipher risk score to guide therapy selection. Decipher score is based on the activity of 22 genes in prostate tumor and may predict how likely it is for recurrent prostate cancer to spread (metastasize) to other parts of the body. Decipher score in this study is used for patient selection and the two variations of treatment to be studied: intensification for higher Decipher score or de-intensification for low Decipher score. Patients with higher Decipher risk score will be assigned to the part of the study that compares the use of 6 months of the usual treatment (hormone therapy and radiation treatment) to the use of darolutamide plus the usual treatment (intensification). The purpose of this section of the study is to determine whether the additional drug can reduce the chance of cancer coming back and spreading in patients with higher Decipher score. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Alternatively, patients with low Decipher risk score will be assigned to the part of the study that compares the use of radiation treatment alone (de-intensification) to the usual approach (6 months of hormone therapy plus radiation). The purpose of this part of the study is to determine if radiation treatment alone is as effective compared to the usual treatment without affecting the chance of tumor coming back in patients with low Decipher score prostate cancer. Radiation therapy uses high energy to kill tumor cells and reduce the tumor size. Hormone therapy drugs such as darolutamide suppress or block the production or action of male hormones that play role in prostate cancer development. Effect of radiation treatment alone in patients with low Decipher score prostate cancer could be the same as the usual approach in stabilizing prostate cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy.

Key Dates

Start date

Dec 6, 2021

Status verified

Apr 2026

Primary completion

Nov 11, 2026

Completion

Nov 11, 2026

Study Design

Enrollment

2,050 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (RT)
  Patients undergo radiation therapy (RT) using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (RT, ADT)
  Patients undergo RT as Arm I. Patients also receive androgen deprivation therapy (ADT) consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days.
• Experimental: Arm III (RT, ADT)
  Patients receive treatment as in Arm II.
• Experimental: Arm IV (RT, ADT, darolutamide)
  Patients receive RT and ADT as in Arm II. Patients also receive darolutamide PO BID on days 1-90. Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Distant metastasis (DM) (De-intensification study) [ Time Frame: From randomization to the detection of distant metastasis by conventional imaging, assessed up to 5 years ]

Locations (567)

Find similar trials in Birmingham, AL

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