Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Dermatologic Agents

Metformin

Diphenhydramine

Promethazine

* Metformin - 850mg PO BID; 48 weeks
* Salvage radiotherapy SRT - 35 x 2Gy; 7 weeks

- Salvage radiotherapy SRT - 35 x 2Gy; 7 weeks

Salvage Radiotherapy SRT

Daniel M. Aebersold, Prof

Alan Dal Pra, MD

The main objective of the trial is to explore the efficacy of salvage radiotherapy (SRT) plus metformin compared to SRT in the endpoint of time to progression after prostatectomy failure.

Although the use of salvage radiotherapy (SRT) is the only potentially curative treatment after prostatectomy failure, it has provided suboptimal results over the years. Metformin may represent an effective and inexpensive means to improve SRT outcomes with a favorable therapeutic ratio. Taken pre-clinical and retrospective clinical data together, there is a compelling rationale for conducting a RCT with SRT and metformin. Herein we propose a multicenter, randomized, open-label, proof-of-concept phase II trial with the hypothesis that the addition of metformin to SRT can delay time to progression compared to the standard-of-care SRT. The study has 1:1 randomization and stratification variables include Gleason score, PSA at SRT, surgical margin status and ADT use.

SAKK 08/15 - PROMET - Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy

SAKK 08/15 - PROMET - Multicenter, Randomized Phase II Trial of Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy

The primary endpoint of the trial is time to progression (TTP), defined as time from randomization until one of the following events, whichever comes first:

* Biochemical progression
* Clinical progression
* Death due to clinical progression

PFS is defined as time from randomization until one of the following events, whichever comes first:

* Biochemical progression
* Clinical progression
* Death from any cause

Undetectable PSA is defined as a serum PSA value of ≤0.05 ng/mL for at least two consecutive measurements after the last radiotherapy fraction and up to 18 months thereafter. To count as undetectable PSA under normal testosterone levels, the testosterone level has to be ≥50 ng/dL (i.e. a non-castrate testosterone level).

50% PSA response is defined as a ≥50% PSA decline after radiotherapy compared to the serum PSA level at randomization up to 18 months after last radiotherapy fraction.

Clinical progression-free survival will be calculated as the time from randomization until clinical progression or death due to any cause.

Time to further anti-cancer systemic therapy (e.g. hormonal treatment) is defined as the time from randomization to the start of any type of salvage systemic treatment.

Prostate cancer-specific survival will be calculated as the time from randomization to the date of death due to prostate cancer.

Overall survival will be calculated as the time from randomization to the date of death from any cause.

AEs will be assessed according to NCI CTCAE v4.03.

Spots Global Cancer Trial Database for salvage radiotherapy srt