Study on Using High Levels of Testosterone to Enhance Chemotherapy in Advanced Prostate Cancer (SPECTRA Study)

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06039371

Provider View

This clinical trial is exploring whether giving high levels of testosterone can improve the effectiveness of chemotherapy in men with advanced prostate cancer that has spread and is resistant to standard hormone treatments.

Patient Parameters

Program Overview

The study aims to find out if high doses of testosterone can help chemotherapy work better in men with prostate cancer that has spread and is no longer responding to hormone therapy. The idea is that high testosterone levels might damage the cancer cells' DNA, making them more vulnerable to chemotherapy drugs like carboplatin and etoposide. These drugs work by killing or slowing the growth of cancer cells. The combination of high testosterone and chemotherapy might be an effective treatment for this type of prostate cancer.

Description

In this study, participants are divided into two main groups, each with three sub-groups:

Group I:

  • Sub-group Ia: Continue hormone therapy and receive testosterone injections on the first day of the first cycle. In following cycles, receive testosterone and carboplatin. Cycles repeat every 28 days unless the cancer worsens or side effects are too severe.
  • Sub-group Ib: Continue hormone therapy and receive carboplatin on the first day of the first cycle. In following cycles, receive testosterone and carboplatin. Cycles repeat every 28 days unless the cancer worsens or side effects are too severe.
  • Sub-group Ic: Continue hormone therapy and receive testosterone and carboplatin on the first day of the first cycle. In following cycles, receive testosterone and carboplatin. Cycles repeat every 28 days unless the cancer worsens or side effects are too severe.

Group II:

  • Sub-group IIa: Continue hormone therapy and receive testosterone injections on the first day of the first cycle. In following cycles, receive testosterone and take etoposide pills daily for 14 days. Cycles repeat every 28 days unless the cancer worsens or side effects are too severe.
  • Sub-group IIb: Continue hormone therapy and take etoposide pills daily for 14 days in the first cycle. In following cycles, receive testosterone and take etoposide pills daily for 14 days. Cycles repeat every 28 days unless the cancer worsens or side effects are too severe.
  • Sub-group IIc: Continue hormone therapy and receive testosterone and take etoposide pills daily for 14 days in the first cycle. In following cycles, receive testosterone and take etoposide pills daily for 14 days. Cycles repeat every 28 days unless the cancer worsens or side effects are too severe.

All participants will have a biopsy and provide blood samples during the study. They will also have bone and CT scans throughout the trial. An optional second biopsy may be done at the end of the treatment. After finishing the study treatment, participants will have follow-up visits 30 days later and then every 6 months for 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to provide informed consent before any study procedures.
  • Age 18 years or older.
  • Confirmed diagnosis of prostate cancer.
  • Cancer must be resistant to hormone therapy and have spread, with a rising PSA level.
  • Must have tried at least one previous hormone therapy without success.
  • No prior chemotherapy for advanced prostate cancer, but previous hormone-sensitive treatment is allowed.
  • Must have adequate blood counts and organ function.
  • Must be able to comply with study requirements, including treatment and visits.
  • Must have at least one tumor that can be measured and biopsied.
  • Must agree to use effective contraception during and after the study.

Exclusion Criteria

  • Involvement in planning or conducting the study.
  • Other cancers unless treated and disease-free for 2 years.
  • Uncontrolled brain metastases or spinal cord compression.
  • Use of high-dose corticosteroids.
  • Concurrent treatment with other cancer therapies.
  • Use of warfarin (other blood thinners may be allowed).
  • Recent major surgery or poor medical condition.
  • Known allergies to study drugs.
  • Active hepatitis B or C.
  • Serious medical or psychiatric conditions that could interfere with the study.
  • Risk of complications from testosterone therapy.
  • Pain from prostate cancer or urinary obstruction due to cancer.
  • Recent history of blood clots or heart failure.

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